| Model Number 99-611530 |
| Device Problem
Break (1069)
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| Patient Problem
No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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Analysis of historical records: orthofix (b)(4) checked the internal records related to the controls made on the device code (b)(4) lot b1266930 (lot marked on the component is g180431) before the market release.No anomalies have been found.The original lot, manufactured in 2018, was comprised of 100 units.All of them have already been distributed to the market.According to orthofix (b)(4) historical records, no other notifications have been received for this specific device lot.Orthofix (b)(4) checked the internal records related to the controls made on the device code (b)(4) lot b1268235 (lot marked on the component is g180431) before the market release.No anomalies have been found.The original lot, manufactured in 2018, was comprised of 200 units.All of them have already been distributed to the market.According to orthofix (b)(4) historical records, no other notifications have been received for this specific device lot.Orthofix (b)(4) checked the internal records related to the controls made on the component code 611530 lot g180431 before the market release.No anomalies have been found.The original lot, manufactured in 2018, was comprised of 725 units, which were assembled in several lots of finished devices.All of them have already been distributed to the market.According to orthofix (b)(4) historical records, no other notifications have been received for this specific component lot.Technical evaluation: the returned devices, received on (b)(6) 2020, were examined by orthofix (b)(4) quality engineering department.In particular it was received all the bone screws used to treat the left tibia of the patient.The devices were subjected to visual and dimensional check as per orthofix (b)(4) specifications.The visual check confirmed the problem notified.Three bone screws are broken.All marked with the lot g180431.The dimensional check, performed where possible, did not evidence any anomalies.The verification of the raw material certificate, used to produce the screws, showed that the material is conforming to orthofix (b)(4) specifications.The broken devices were then sent to an external laboratory to verify the material conformity and for further investigation.Please find below an extract of the technical evaluation received: "according to the findings, the failed item consists of an aisi 316 lvm austenitic stainless steel as expected, with a regular microstructure of austenitic matrix, with the presence of shear bands, indicating some degree of cold-working.The average core hardness value (after three readings) is around 330 hv10 for every sample, consistent with the observed microstructure.The fracture was nucleated in the correspondence of a thread root.The section analysis shows the presence of small secondary cracks, sometimes multiple, on near threads.In correspondence of the nucleation, no microstructural anomalies, nor relevant surface notches can be observed.The fractographic clues consistently indicate a fatigue propagation fracture, likely due to a flexural load.This type of load is coherent with expected usage modality for the screw and may be related to an excessive, or unbalanced, load distribution." medical evaluation: the information made available on the event together with the results of the technical evaluation were sent to our medical evaluator.Please find below an extract of the medical evaluations performed.-(b)(6) 2020: "this event took place in (b)(6), where a patient was having bilateral tibial lengthening.The report states that information is hard to discover because the original surgeon seems to have moved to another hospital.The original report states that the patient had the fixation applied on (b)(6) 2019, which is just over 9 months ago.An lrs with osteotite screws size 150/30 was in place and the middle distal screw has broken.It looks as though the proximal screw on each side is 150/40 and the remaining screws 150/30, which is correct for these tibiae.Later information adds that the patient is (b)(6) years old and is having bilateral tibial lengthening.The patient has short stature and a diagnosis of osteogenesis imperfecta is suggested.An x-ray series has been sent from the time of just before fixator application until (b)(6) 2020.The x-rays show a very well applied adult lrs fixator on each tibia.There are no open epiphyses and there is no sign of osteogenesis imperfecta.I do not think that any surgeon would be doing bilateral lengthening with external fixation on a patient with this diagnosis, so we can exclude that.I also suggest that the patient is significantly older than (b)(6), probably late teenage or in her 20's.The pelvis (not all is visible) seems to be in proportion to the femora and the patient may have short stature with normal bones, not achondroplasia.It is unusual to see such well applied external fixation, although i have grown accustomed to it from (b)(6).There are 3 screws in each clamp; they are all in the 1-3-5 positions in each clamp and are perfectly parallel to each other.The thread length is perfectly chosen.It is a text-book example of a tibial lengthening application.The osteotomy is diaphyseal but that cannot be avoided in such short bones.The series of xrays show gradual lengthening and later good callus formation up to the february x-ray, when a single broken screw is obvious with separation (screw 5, counting from proximal), and screw 4 is also broken but in continuity.Just before secondary surgery on (b)(6) it is now obvious that 3 screws have broken, 2, 4 and 5 on the left side, none on the right.This is quite extraordinary for several reasons: - the working length of each clamp (distance from osteotomy) is the same, so the loading will be very similar.- all screws are spaced widely in each clamp for maximum fixation strength.- 6.0 - 5.6 mm osteotite screws are used throughout, which is quite correct.- the first screw of each clamp to break seems to have been the middle screw of each clamp, which should be the most protected screw.- normally the screw nearest the osteotomy has the greatest load and if any are to break this is the first.I have never seen this happen before, and it is difficult to understand why it has happened.The patient has had 2 locking plates applied to the left leg after the fixator and screws were removed.It seems that the length gained has been preserved.I think that the very extensive fixation applied to the left leg may be partly die to the fact that the surgeon had to remove a cylinder of bone with each osteotite screw fragment, potentially weakening the bone.This is a most extraordinary sequence of events and i cannot offer a biomechanical reason for it".-(b)(6) 2020 with the information about the last broken screw: "the saga with this patient in (b)(6) continues.Once again an osteotite screw has broken in this very well applied frame.The photographs of the screws sections that you also sent provide classic examples of fatigue fractures.I think that i now know why this series of events has happened.This patient is having bilateral tibial lengthening.The patient has 6 osteotite screws to each fixator, evenly spaced so that the load will be spread evenly.The patient is (b)(6)years old and (b)(6) kg in weight.I think that this patient has no alternative but to fully weightbear on each leg.I think that because the fixation with the ha coated screws is so good, it feels very secure to the patient, who is very active as a result.This patient has been too active because the fixation is so good.There should be limited partial weightbearing until continuous callus is visible on the x-rays, using crutches and a wheelchair for longer distances.I feel certain that these breakages have happened because the patient has been very active.We should explain to the distributor that breakage of these screws is excessively rare.When it does occur it is because the fatigue life of the bone screw has been reached by repeated cyclic loading.I would love to see a video of this patient moving about.So we can be sure that these screws have been loaded beyond their design criteria, causing fatigue failure of the screws".-(b)(6) 2020 with the results of the technical analysis performed on the returned broken screws: "the technical report confirms our thoughts that these screws had been subject to excessive flexural loading which has caused fatigue failure of the screws.The screws themselves are fully to specification.As stated already, this is excessively rare and will be due in part to the excellent grip on the bone of the ha coated screws, which has lead to excessive loading of the frame.The patient should not have been walking for much of the time, because this was a bilateral lengthening, so partial weightbearing was impossible.I agree with the conclusions of the report".Conclusion: the results of the technical evaluation concluded that the three returned broken screws were originally conforming to orthofix specifications.The breakages occurred are mainly attributable to fatigue failure most likely related to an excessive cyclic load applied.Orthofix can assume that the outcome of this evaluation is also applicable to the fourth screw that broke on the same patient, which is still in use by patient and therefore not available for the evaluation.The medical evaluation evidenced as follows: "the technical report confirms our thoughts that these screws had been subject to excessive flexural loading which has caused fatigue failure of the screws.The screws themselves are fully to specification.As stated already, this is excessively rare and will be due in part to the excellent grip on the bone of the ha coated screws, which has lead to excessive loading of the frame.The patient should not have been walking for much of the time, because this was a bilateral lengthening, so partial weightbearing was impossible".Based on the results of the technical evaluation, and on the evidences deriving from the medical evaluation, orthofix (b)(4) can conclude that the problem that occurred is not device related.The analysis of the historical data evidenced that no other notifications have been received on devices belonging to the same lot.Orthofix continues monitoring the products on the market.Please also kindly refer to mfr report 9680825-2020-00028 and 9680825-2020-00029 and 9680825-2020-00030.- (b)(4).
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Event Description
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The information initially provided by the local distributor indicates: - product code: 99-611530.- batch number: b1266930 or b1268235.- quantity: 1.- hospital name: (b)(6).- surgeon name: unknown.- date of surgery: (b)(6) 2019.- body part to which device was applied: left tibia - bone lengthening.- surgery description: correction.- patient information: female.- problem observed during: into treatment/post-operative.- type of problem: device functional problem.- event description: "the distal middle screw broke during left tibia extension.We have been contacted by doctors for instructions on how to replace and remove screws.The surgeon asked to us that are similar events occurring at other hospital.The surgeon will perform a screw replacement operation on (b)(6), but no information is available on the specific procedure.The screw broke on (b)(6).The surgeon suggests that other screws may also be broken".The complaint report form also indicates: - the device failure had adverse effects on patient.- the initial surgery was completed with the device.- the event did not lead to a clinically relevant increase in the duration of the surgical procedure.- an additional surgery was required (date: (b)(6) 2020).- copies of the operative reports are not available.- copies of the x-ray images are not available.- patient current health condition: unknown.On (b)(6) 2020, orthofix (b)(4) received the following additional information: - name of the surgeon: (b)(6).- patient age and weight: "female, (b)(6) years old, (b)(6) kg" - patient diagnosis and proposed treatment: "the treatment proposed is unknown because dr.(b)(6) moved in (b)(6).We determined from the radiographs that the patient was short stature (osteogenesis imperfecta)." - lengthening planned and lengthening achieved before screw breakage: "the extension distance when the screw was broken was 67 mm.It was originally planned to be extended by 70mm." - copies of the x-rays images are available.- patient current health condition: "the plate is adapted to the affected area of the patient." - three screws were broken in total (mfr report 9680825-2020-00028 and 9680825-2020-00029 and 9680825-2020-00030).Further information and x-ray images received on (b)(6) 2020: on (b)(6) 2020, the distributor informed that another bone screw broke on this patient (mfr report.This last event was identified with number (b)(4).Below are reported the information included in the complaint form provided in regards to this last breakage.- device code: (b)(4).- batch number: b1266930 or b1268235.- quantity: 1.- hospital name: (b)(6).- surgeon name: (b)(6).- date of initial surgery: (b)(6) 2019.- body part to which device was applied: right tibia - bone lengthening.- surgery description: correction.- patient information: (b)(6) years, female, (b)(6) kg.- problem observed during: into treatment/post-operative.- type of problem: device functional problem.- event description: "the distal screw of proximal clamp broke during right tibia extension.This complaints is the same patient of (b)(4).The patient has experienced broken four screws.The surgeon continues to treat the patient because there is only one screw broken in the patient's right foot.We are asked to explain to the patient family what caused the screw to break.We would like a medical advisor to seek advice".The complaint report form also indicated: - the device failure did not have any adverse effects on patient.- the initial surgery was completed with the device.- the event did not lead to a clinically relevant increase in the duration of the surgical procedure.- an additional surgery was not required.- a medical intervention (outpatient clinic) was not required.- copies of the operative reports are not available.- copies of the x-ray images are available.- availability of the device: once the bone extension is complete and the screw is removed as scheduled, we can ship it to you.- the event should be notified to the (b)(6) competent authority.- patient current health condition: the patient's right foot still has an external fixator.Manufacturer ref: (b)(4).Distributor ref: (b)(4).
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Manufacturer Narrative
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Analysis of historical records orthofix srl checked the internal records related to the controls made on the device code 99-611530 lot b1266930 (lot marked on the component is g180431) before the market release.No anomalies have been found.The original lot, manufactured in 2018, was comprised of 100 units.All of them have already been distributed to the market.According to orthofix srl historical records, no other notifications have been received for this specific device lot.Orthofix srl checked the internal records related to the controls made on the device code 99-611530 lot b1268235 (lot marked on the component is g180431) before the market release.No anomalies have been found.The original lot, manufactured in 2018, was comprised of (b)(4) units.All of them have already been distributed to the market.According to orthofix srl historical records, no other notifications have been received for this specific device lot.Orthofix srl checked the internal records related to the controls made on the component code 611530 lot g180431 before the market release.No anomalies have been found.The original lot, manufactured in 2018, was comprised of 725 units, which were assembled in several lots of finished devices.All of them have already been distributed to the market.According to orthofix srl historical records, no other notifications have been received for this specific component lot.Original technical evaluation the returned devices, received on march 17, 2020, were examined by orthofix srl quality engineering department.In particular it was received all the bone screws used to treat the left tibia of the patient.The devices were subjected to visual and dimensional check as per orthofix srl specifications.The visual check confirmed the problem notified.Three bone screws are broken.All marked with the lot g180431.The dimensional check, performed where possible, did not evidence any anomalies.The verification of the raw material certificate, used to produce the screws, showed that the material is conforming to orthofix srl specifications.The broken devices were then sent to an external laboratory to verify the material conformity and for further investigation.Please find below an extract of the technical evaluation received: "according to the findings, the failed item consists of an aisi 316 lvm austenitic stainless steel as expected, with a regular microstructure of austenitic matrix, with the presence of shear bands, indicating some degree of cold-working.The average core hardness value (after three readings) is around 330 hv10 for every sample, consistent with the observed microstructure.The fracture was nucleated in the correspondence of a thread root.The section analysis shows the presence of small secondary cracks, sometimes multiple, on near threads.In correspondence of the nucleation, no microstructural anomalies, nor relevant surface notches can be observed.The fractographic clues consistently indicate a fatigue propagation fracture, likely due to a flexural load.This type of load is coherent with expected usage modality for the screw and may be related to an excessive, or unbalanced, load distribution." supplementary technical evaluation on july 8, 2020, orthofix received the last screw that broke on this patient.The returned screw was subjected to visual and dimensional check as per orthofix srl specifications.The visual check confirmed the problem notified.The bone screw is broken.Also this one, like the other three screws already examined, is marked with the lot g180431.The dimensional check, performed where possible, did not evidence any anomalies.The lot of the returned bone screw is the same of the other three broken bone screws which were already tested.The verification of the fracture surfaces concluded that also this bone screw broke due to fatigue failure.The technicians decided that it was not necessary to repeat the other tests also on this broken screw, using an external laboratory, as the results of the failure analysis performed on the other bone screws that broke is also deemed to be applicable to this one.Original medical evaluation the information made available on the event together with the results of the technical evaluation were sent to our medical evaluator.Please find below an extract of the medical evaluations performed.-(b)(6) 2020: "this event took place in japan, where a patient was having bilateral tibial lengthening.The report states that information is hard to discover because the original surgeon seems to have moved to another hospital.The original report states that the patient had the fixation applied on may 23rd 2019, which is just over 9 months ago.An lrs with osteotite screws size 150/30 was in place and the middle distal screw has broken.It looks as though the proximal screw on each side is 150/40 and the remaining screws 150/30, which is correct for these tibiae.Later information adds that the patient is 13 years old and is having bilateral tibial lengthening.The patient has short stature and a diagnosis of osteogenesis imperfecta is suggested.An x-ray series has been sent from the time of just before fixator application until february 2020.The x-rays show a very well applied adult lrs fixator on each tibia.There are no open epiphyses and there is no sign of osteogenesis imperfecta.I do not think that any surgeon would be doing bilateral lengthening with external fixation on a patient with this diagnosis, so we can exclude that.I also suggest that the patient is significantly older than 13, probably late teenage or in her 20's.The pelvis (not all is visible) seems to be in proportion to the femora and the patient may have short stature with normal bones, not achondroplasia.It is unusual to see such well applied external fixation, although i have grown accustomed to it from japan.There are 3 screws in each clamp; they are all in the 1-3-5 positions in each clamp and are perfectly parallel to each other.The thread length is perfectly chosen.It is a text-book example of a tibial lengthening application.The osteotomy is diaphyseal but that cannot be avoided in such short bones.The series of xrays show gradual lengthening and later good callus formation up to the february x-ray, when a single broken screw is obvious with separation (screw 5, counting from proximal), and screw 4 is also broken but in continuity.Just before secondary surgery on february 20th it is now obvious that 3 screws have broken, 2, 4 and 5 on the left side, none on the right.This is quite extraordinary for several reasons: - the working length of each clamp (distance from osteotomy) is the same, so the loading will be very similar - all screws are spaced widely in each clamp for maximum fixation strength - 6.0 - 5.6 mm osteotite screws are used throughout, which is quite correct - the first screw of each clamp to break seems to have been the middle screw of each clamp, which should be the most protected screw - normally the screw nearest the osteotomy has the greatest load and if any are to break this is the first i have never seen this happen before, and it is difficult to understand why it has happened.The patient has had 2 locking plates applied to the left leg after the fixator and screws were removed.It seems that the length gained has been preserved.I think that the very extensive fixation applied to the left leg may be partly die to the fact that the surgeon had to remove a cylinder of bone with each osteotite screw fragment, potentially weakening the bone.This is a most extraordinary sequence of events and i cannot offer a biomechanical reason for it".-april 18, 2020 with the information about the last broken screw: "the saga with this patient in japan continues.Once again an osteotite screw has broken in this very well applied frame.The photographs of the screws sections that you also sent provide classic examples of fatigue fractures.I think that i now know why this series of events has happened.This patient is having bilateral tibial lengthening.The patient has 6 osteotite screws to each fixator, evenly spaced so that the load will be spread evenly.The patient is 13 years old and 45 kg in weight.I think that this patient has no alternative but to fully weightbear on each leg.I think that because the fixation with the ha coated screws is so good, it feels very secure to the patient, who is very active as a result.This patient has been too active because the fixation is so good.There should be limited partial weightbearing until continuous callus is visible on the x-rays, using crutches and a wheelchair for longer distances.I feel certain that these breakages have happened because the patient has been very active.We should explain to the distributor that breakage of these screws is excessively rare.When it does occur it is because the fatigue life of the bone screw has been reached by repeated cyclic loading.I would love to see a video of this patient moving about.So we can be sure that these screws have been loaded beyond their design criteria, causing fatigue failure of the screws".-april 22, 2020 with the results of the technical analysis performed on the returned broken screws: "the technical report confirms our thoughts that these screws had been subject to excessive flexural loading which has caused fatigue failure of the screws.The screws themselves are fully to specification.As stated already, this is excessively rare and will be due in part to the excellent grip on the bone of the ha coated screws, which has lead to excessive loading of the frame.The patient should not have been walking for much of the time, because this was a bilateral lengthening, so partial weightbearing was impossible.I agree with the conclusions of the report".Supplementary medical evaluation as specifically requested by japan medicalnext, the information made available on the event together with the results of the technical evaluation were sent to another medical evaluator.Please find below an extract of the medical evaluation performed."this involves a case of bilateral simultaneous tibial lengthening in a patient treated at the kitakyusyu rehabilitation centre for children with disabilities.Whist it's not completely clear it is inferred that the primary surgery was carried out in may 2019.There have been subsequent surgeries performed since this date.The exact aetiology and pathogenesis around this case is unclear and the background to the short stature and the diagnosis was not originally provided.Further email correspondence has suggested multiple epiphyseal dysplasia (med) as a diagnosis.Whilst this is not pivotal to the case, it would be useful to know the exact circumstances around diagnosis, preoperative assessment and counseling cognitive function and functional demand.There is a mention, again in email regarding crutch use although its unclear if this is preoperative.Equally the circumstances around postoperative rehabilitation plan and the mobility state over the time following surgery would be informative.Again this is not absolutely required and should not delay the case but it would help provide a more complete assessment.The crux of this case is focused around the mechanical failure of xcaliber osteotite screws (6mm-5.6mm) used as bone interface with a lrs device.There are no other reported issues with the device.There are no reported issues with either the rail or the fixation elements / clamps.This issue is as stated one of fatigue of the stainless steel half pin.Having focused the issue down onto the half pins thus attention can be given to the batch materials.Orthofix have carried out a significant analysis of the materials of the half pin and the microstructural environment around the fractured pin element.My subject matter expertise is not in material technology but my reading of the investigations suggests nothing other than fatigue failure.Following the thread thus far it is possible to identify a number or areas that may be contributory: 1).Time in frame i am confused as to the duration of lrs management for this osteoclasis.Following corticotomy a rate of 0.75-1mm lengthening a day is normally prescribed.The index procedure was in may 2019.Allowing for a latent period we could assume conservatively that the lengthening period started on june 1st 2019.To gain around 6.5cm length there would elapse around 90 days.This would infer that the lengthening stage should have been complete by or around september 2019.This is a conservative estimate and could well have finished a few weeks sooner.What confuses me is why, having completed the lengthening at this point, the frame was still on in february the following year.This is a rhetorical question - it means that the clinical path was not straightforward.The radiographs show poor regenerate formation and consolidation.Reviewing the radiographs from november 2019 and january 2020 the first impression is that these show poor regenerate and do not resemble the regenerate expected from a child.Conservatively this child had bilateral frames for at least 9 months and at this time the bone had still not fully consolidated.There are several series utilizing lrs in which frame removal time is quicker than this in far more complex cases, including considerable soft tissue destruction, bone loss and poor hosts.Controlled low energy osteotomy, in a child, with no soft tissue destruction should be associated with more bone formation and significantly less time in frame.2).Weightbearing as discussed above i would like to have sight of the rehabilitation plan.It is unclear what this is.By inference however, bilateral simultaneous surgery may mean that the child was fully weightbearing as it would not be sensible to nonweightbear in an elective setting for a considerable time frame.With at least nine months of treatment there is inferred therefore a considerable loading, through full weightbearing, on the construct.This put simply, means that the half pins were subject to considerable cantilever loading for a considerable period of time.3).Host factors as mentioned above, the clinical details are not completely clear.The age of the patient is in considerable doubt.The radiographical features and the clinical information do not concur.The physes are closed.The diagnosis is not clear - i can see no pathognomic features of med.Equally, metabolic information or any underlying bone biochemistry or endocrine disturbance is not made clear.Equally, cognition and ability to comply with protected weightbearing or a rehabilitation prescription is not clear.-summary: this case did not follow a normal clinical path.The frame materials have been subject to loading over a prolonged period of time that i imagine was not planned for.The case is still not complete as the most recent radiographs do not demonstrate consolidation and the left leg has now been subject to a considerable revision surgical procedure using an internal fixation construct.In the most basic sense, it does not surprise me to see that a complication (not device related) has occurred.Any material subject to this loading over this period of time carries a risk of failure.There has been excellent bonding of the pin to the bone and the metal has failed at this strain interface.There has been expected and natural fatigue failure of a metal exposed to excessive cyclical loading due to the presumed weightbearing and failure of the bone to provide innate offloading as it fails to consolidate in a timely manner.In essence, the pins have [?]had to do too much' and they failed which is part of normal implant / frame material behaviour.This statement is based upon the facts as provided and i cannot comment on the clinical decision making only to confirm that i do not believe there is any grounds for there to be any concern over the performance of the device".Conclusion the results of the technical evaluation concluded that all the returned broken screws were originally conforming to orthofix specifications.The breakages occurred are mainly attributable to fatigue failure most likely related to an excessive cyclic load applied.Based on the results of the technical evaluation, and on the evidences deriving from the medical evaluations, orthofix srl can conclude that the problem that occurred is not device related.The analysis of the historical data evidenced that no other notifications have been received on devices belonging to the same lot.Orthofix continues monitoring the products on the market.- attachment: [2020046_fda medwatch cover letter_follow up 1_35.Pdf].
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Event Description
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The information initially provided by the local distributor indicates: product code: 99-611530 batch number: b1266930 or b1268235.Quantity: 1.Hospital name: (b)(6).Surgeon name: unknown.Date of surgery: (b)(6) 2019.Body part to which device was applied: left tibia bone lengthening.Surgery description: correction.Patient information: female.Problem observed during: into treatment/postoperative.Type of problem: device functional problem.Event description: "the distal middle screw broke during left tibia extension.We have been contacted by doctors for instructions on how to replace and remove screws.The surgeon asked to us that are similar events occurring at other hospital.The surgeon will perform a screw replacement operation on (b)(6), but no information is available on the specific procedure.The screw broke on (b)(6).The surgeon suggests that other screws may also be broken." the complaint report form also indicates: the device failure had adverse effects on patient.The initial surgery was completed with the device.The event did not lead to a clinically relevant increase in the duration of the surgical procedure.An additional surgery was required (date: (b)(6) 2020).Copies of the operative reports are not available copies of the xray images are not available.Patient current health condition: unknown.On february 27, 2020, orthofix srl received the following additional information: name of the surgeon: "dr.(b)(6)." patient age and weight: "female, 13 years old, 45 kg." patient diagnosis and proposed treatment: "the treatment proposed is unknown because dr.Kawamura moved in october.We determined from the radiographs that the patient was short stature (osteogenesis imperfecta)." lengthening planned and lengthening achieved before screw breakage: "the extension distance when the screw was broken was 67 mm.It was originally planned to be extended by 70mm" copies of the x-rays images are available patient current health condition: "the plate is adapted to the affected area of the patient." three screws were broken in total (mfr report 9680825-2020-00028 and 9680825-2020-00029 and 9680825-2020-00030).Further information and x-ray images received on april 13, 2020: on april 13, 2020, the distributor informed that another bone screw broke on this patient (mfr report 9680825-2020-00035).This last event was identified with number 2020-0032.Below are reported the information included in the complaint form provided in regards to this last breakage.Device code: 99-611530 - batch number: b1266930 or b1268235 - quantity: 1 - hospital name: (b)(6).- surgeon name: dr.(b)(6).- date of initial surgery: (b)(6) 2019 - body part to which device was applied: right tibia - bone lengthening - surgery description: correction - patient information: 14 years, female, 45 kg - problem observed during: into treatment/post-operative - type of problem: device functional problem - event description: "the distal screw of proximal clamp broke during right tibia extension.This complaints is the same patient of (b)(6).The patient has experienced broken four screws.The surgeon continues to treat the patient because there is only one screw broken in the patient's right foot.We are asked to explain to the patient family what caused the screw to break.We would like a medical advisor to seek advice".The complaint report form also indicated: - the device failure did not have any adverse effects on patient - the initial surgery was completed with the device - the event did not lead to a clinically relevant increase in the duration of the surgical procedure - an additional surgery was not required - a medical intervention (outpatient clinic) was not required - copies of the operative reports are not available - copies of the x-ray images are available - availability of the device: once the bone extension is complete and the screw is removed as scheduled, we can ship it to you - the event should be notified to the japanese competent authority - patient current health condition: the patient's right foot still has an external fixator further information and images received on june 25, 2020 on june 25, 2020, japan medicalnext informed that the last bone screw that broke on this patient is available (event number (b)(4)).Below are reported the information included in the revised complaint form.- device code: 99-611530 - batch number: b1266930 or b1268235 (g180431) - quantity: 1 - hospital name: (b)(6).- surgeon name: dr.(b)(6).- date of initial surgery: (b)(6) 2019 - body part to which device was applied: right tibia - bone lengthening multiple epiphyseal dysplasia - surgery description: correction - patient information: 14 years, female, 45 kg; the patient is not so active.Her character is very calm and smart, and she has been listening instructions from the surgeons.She uses crutches or walking assist device for disabled during her walking - problem observed during: into treatment/post-operative - type of problem: device functional problem - event description: the distal screw of proximal clamp broke during right tibia extension.This complaints is the same patient of (b)(6).The patient has experienced broken four screws.The surgeon continues to treat the patient because there is only one screw broken in the patient's right foot.We are asked to explain to the patient family what caused the screw to break.We would like a medical advisor to seek advice.- additional information: the surgeon found a broken screw on an x-ray on april 1.The screw was used until the removal operation on june 11th.The surgery removed the external fixation and replaced the plate.The part of fibula is transplanted to the tibia.The screw removal surgery was performed on (b)(6), and six screws were shipped to us and received on june 18.The surgeon wants to know the following: method and results of screw component analysis.Measures for procedures to prevent similar screw breakage in the future.They are requesting us to suggest any reasons causing screw breakages.The complaint report form also indicated: - the device failure had any adverse effects on patient - the initial surgery was completed with the device - the event did not lead to a delay in the duration of the surgical procedure - an additional surgery was not required - a medical intervention (outpatient clinic) was not required - copies of the operative reports are not available - copies of the x-ray images are available - product is available for return - the event should be notified to the japanese competent authority - patient current health condition: the patient's right foot still has an external fixator manufacturer ref: (b)(4).Distributor ref: (b)(4).
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Search Alerts/Recalls
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