| Model Number UNKNOWN (PRESUMED CODE 99-612660) |
| Device Problem
Mechanical Problem (1384)
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| Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
Injury
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Manufacturer Narrative
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Analysis of historical records tl hex ring: orthofix (b)(4) checked the internal records related to the controls made on the device code 99-56-23120 batch v1391444 (lot laser marked on the component v1391157) before the market release.No anomalies have been found.The original lot, manufactured in 2015, was comprised of (b)(4) devices.All of them have already been distributed to the market.According to orthofix (b)(4) historical records, no other similar notifications have been received on this specific device code (please kindly refer to mfr report 9680825-2016-00053).Bone screw: the bone screw involved in this event has not yet been received by orthofix (b)(4) (the tip was left on patient bone while the stem has not yet made available).Unfortunately also the code and the lot number have not been made available and therefore it was not possible to perform the verification of the historical data (please kindly refer to mfr report 9680825-2016-00054).Technical evaluation: the technical evaluation on the retuned ring is currently on going (please kindly refer to mfr report 9680825-2016-00053).The bone screw has not yet been received by orthofix (b)(4).The technical evaluation of the bone screw will be performed as soon as it becomes available (please kindly refer to mfr report 9680825-2016-00054).Medical evaluation: the information made available on the event was sent to our medical evaluator.A preliminary medical evaluation was performed and will be finalized once the results of the technical evaluation will be available.As soon as further information and/or the results of the technical evaluation will be available, orthofix (b)(4) will provide you with a follow up report.Orthofix (b)(4) continues monitoring the devices on the market.Device not returned.
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Event Description
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The information provided by the local distributor indicates: product codes: 99-56-23120 (please refer to mfr report 9680825-2016-00053) & 1 bone screw code and batch unknown (please refer to mfr report 9680825-2016-00054).Batch numbers: v1391444 & unknown.Hospital name: (b)(6).Surgeon name: (b)(6).Date of surgery: (b)(6) 2016.Body part to which device was applied: femur.Surgery description: lengthening.Patient information: (b)(6) years, male.Problem observed during: clinical use on patient.Type of problem: device functional problem.Event description: "the patient had a tl hex fixator applied on the right femur for mainly correcting an "ipometria" of the femur of about 3-4 cm.The initial surgery was performed in january using a total of 3 tl-hex rings: a 5/8 ring (200mm) opened posteriorly, connected by 4 simple threaded rods to a full ring (5/8 + 3/8, ring of 220 mm) positioned in slightly more proximal metaphyseal area, connected with 6 tl-hex struts to a 5/8 ring (220 mm) opened medially.Finally, the whole frame was connected to a femoral arch, using threaded rods and oblique supports.There were no positioning problems during surgery and also the gradual correction was successfully performed.After about 4 months from the surgery, when the correction was concluded and the patient was in consolidation phase, the surgeon - dr.(b)(6) - informed that a bone screw, positioned in metaphyseal region and anchored to the full ring (5/8 + 3/8), broke.Unfortunately, the details of this screw (measure, code and batch) cannot be determined as the stem, which reports the code, was cut at the time of the initial surgery, while the threaded tip is still in the patient's bone.Potential batches (as shown on the labels of the intervention sheet) are: v1400691 (corresponding to bone screw code 99-611540); v1374583 (corresponding to bone screw code 99-612660); v1404111 (corresponding to bone screw code 99-612660).As i began to collect and to request the first data to open a complaint concerning the bone screw, the surgeon sends me a second message in which he explains that the connection part of the 3/8 ring is completely broken.Fortunately a replacement part was available, to stabilize the frame without serious consequences on the patient.The surgeon told me that in this final consolidation phase, the patient was permitted to have "free load" as tolerated with the aid of two sticks type "(b)(4)" to ensure equilibrium.The patient weighs about (b)(6), but has not been reported any falls or accidental impacts".The complaint report form also indicates: the devices failure did not have any adverse effects on patient.The surgery was completed with the used devices.The event did not lead to a clinically relevant increase in the duration of the surgical procedure.An additional surgery was not required.Copies of the operative reports are not available.Copies of the x-rays images are available.Patient current health condition: the patient is in good health conditions.Please also kindly refer to mfr report 9680825-2016-00053.(b)(4).
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Manufacturer Narrative
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Analysis of historical records: tl hex ring: orthofix (b)(4) checked the internal records related to the controls made on the device code 99-56-23120 batch (b)(4) (lot laser marked on the component v1391157) before the market release.No anomalies have been found.The original lot, manufactured in 2015, was comprised of (b)(4) devices.All of them have already been distributed to the market.According to orthofix (b)(4) historical records, no other similar notifications have been received on this specific device code (please kindly refer to mfr report 9680825-2016-00053).Bone screw: the bone screw involved in this event has not yet been received by orthofix (b)(4) (the tip was left on patient bone while the stem is not available).Unfortunately also the code and the lot number have not been made available and therefore it was not possible to perform the verification of the historical data (please kindly refer to mfr report 9680825-2016-00054).Technical evaluation: the technical evaluation on the retuned ring is currently on going (please kindly refer to mfr report 9680825-2016-00053).The bone screw has not yet been received by orthofix (b)(4).The technical evaluation of the bone screw will be performed as soon as it becomes available (please kindly refer to mfr report 9680825-2016-00054).Medical evaluation: the information made available on the event was sent to our medical evaluator.A preliminary medical evaluation was performed and will be finalized once the results of the technical evaluation will be available.As soon as further information and/or the results of the technical evaluation will be available, orthofix (b)(4) will provide you with a follow up report.Orthofix (b)(4) continues monitoring the devices on the market.
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Event Description
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The information initially provided by the local distributor indicates: product codes: 99-56-23120 (please refer to mfr report 9680825-2016-00053) & 1 bone screw code and batch unknown (please refer to mfr report 9680825-2016-00054).Batch numbers: (b)(4) & unknown.Hospital name: (b)(6).Surgeon name: (b)(6).Date of surgery: (b)(6) 2016.Body part to which device was applied: femur.Surgery description: lengthening.Patient information: (b)(6), male, (b)(6).Problem observed during: clinical use on patient.Type of problem: device functional problem.Event description: "the patient had a tl hex fixator applied on the right femur for mainly correcting an "ipometria" of the femur of about 3-4 cm.The initial surgery was performed in (b)(6) using a total of 3 tl-hex rings: a 5/8 ring (200mm) opened posteriorly, connected by 4 simple threaded rods to a full ring (5/8 + 3/8, ring of 220 mm) positioned in slightly more proximal metaphyseal area, connected with 6 tl-hex struts to a 5/8 ring (220 mm) opened medially.Finally, the whole frame was connected to a femoral arch, using threaded rods and oblique supports.There were no positioning problems during surgery and also the gradual correction was successfully performed.After about 4 months from the surgery, when the correction was concluded and the patient was in consolidation phase, the surgeon - dr.(b)(6) - informed that a bone screw, positioned in metaphyseal region and anchored to the full ring (5/8 + 3/8), broke.Unfortunately the details of this screw (measure, code and batch) cannot be determined as the stem, which reports the code, was cut at the time of the initial surgery, while the threaded tip is still in the patient's bone.Potential batches (as shown on the labels of the intervention sheet) are: (b)(4) (corresponding to bone screw code 99-611540), (b)(4) (corresponding to bone screw code 99-612660), (b)(4) (corresponding to bone screw code 99-612660).As i began to collect and to request the first data to open a complaint concerning the bone screw, the surgeon sends me a second message in which he explains that the connection part of the 3/8 ring is completely broken.Fortunately a replacement part was available, to stabilize the frame without serious consequences on the patient.The surgeon told me that in this final consolidation phase, the patient was permitted to have "free load" as tolerated with the aid of two sticks type "(b)(6)" to ensure equilibrium.The patient weighs about (b)(6), but has not been reported any falls or accidental impacts".The complaint report form also indicates: the devices failure did not have any adverse effects on patient.The surgery was completed with the used devices.The event did not lead to a clinically relevant increase in the duration of the surgical procedure.An additional surgery was not required.Copies of the operative reports are not available.Copies of the x-rays images are available.Patient current health condition: the patient is in good health conditions.On june 22, 2016, orthofix (b)(4) received the following additional information: the stem of the bone screw is not available.The tip of the bone screw is in the patient's bone, an intervention for its removal is not planned.Please also kindly refer to mfr report 9680825-2016-00053.(b)(4).
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Manufacturer Narrative
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Analysis of historical records tl hex ring: orthofix (b)(4) checked the internal records related to the controls made on the device code 99-56-23120 batch (b)(4) (lot laser marked on the component (b)(4)) before the market release.No anomalies have been found.The original lot, manufactured in 2015, was comprised of (b)(4) devices.All of them have already been distributed to the market.According to orthofix (b)(4) historical records, no other similar notifications have been received on this specific device code (please kindly refer to mfr report 9680825-2016-00053).Bone screw: the bone screw involved in this event has not yet been received by orthofix (b)(4) (the tip was left on patient bone while the stem is not available).Unfortunately also the code and the lot number have not been made available and therefore it was not possible to perform the verification of the historical data (please kindly refer to mfr report 9680825-2016-00054).Technical evaluation the returned device, ring code 99-56-23120, received on june 7, 2016, was examined by orthofix (b)(4) quality engineering area (please kindly refer to mfr report 9680825-2016-00053).The returned device was subject to visual and dimensional check as per orthofix (b)(4) product specification.The visual check confirmed the problem notified: the ring is broken in correspondence to the connecting point with another ring (used to create a whole ring).The dimensional check, performed where possible, did not evidence any anomalies.The device was then sent to an external laboratory for the chemical analysis.The results of the technical evaluation evidenced that the returned ring was originally conforming to orthofix (b)(4) specification.The breakage occurred is a result of a combination of a fatigue component with a axial overload component related to the specific application.The involved bone screw has not yet been received by orthofix (b)(4) (the tip of the screw is still on patient while the stem is not available).The technical evaluation of the bone screw will be performed as soon as it becomes available (please kindly refer to mfr report 9680825-2016-00054).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.On (b)(6) 2016: "this patient has a tl-hex frame over a femur that requires lengthening and alignment adjustment, consisting of 2 distal rings, and a proximal 5/8 ring and 2 femoral arches.Both the distal rings are 5/8 rings, the proximal one being completed to a full ring with a 3/8 attachment.The bone screws are all ha coated xcaliber screws.To my mind the distal screws have excessively long threads, 60 to 80 mm.There are 4 proximal and 4 distal screws.The proximal screws are all lateral, as are 3 of the distal ones.One distal screw is medial and this is the one that broke.I think that both of these components broke because of fatigue failure, and that the design of the frame resulted in load being focused on them, so that they were loaded beyond their design criteria.It is very unusual for xcaliber screws to break.The screw that broke here was the only one inserted from the medial side.This positioning will have increased the cyclic loading on this screw, which is isolated mechanically, and so this one failed.When it failed, increased cyclic load will have been applied to the frame.The fact that the patient was fully weightbearing will also be relevant.So, i suggest that these components failed in fatigue because their fatigue life was exceeded.The use of a single full ring might have prevented this failure.It may have been better to insert all of the distal screws from the lateral side so that they could share the load".On july 8, 2016 with the results of the technical evaluation performed on the ring: "regarding this case, i agree that this failure was application related".Final comments: the results of the technical evaluation evidenced that the returned ring was originally conforming to orthofix (b)(4) specification.The breakage occurred is a result of a combination of a fatigue component with a axial overload component related to the specific application.The involved bone screw has not yet been received by orthofix (b)(4) (the tip of the screw is still on patient while the stem is not available).The technical evaluation of the bone screw will be performed as soon as it becomes available.The medical evaluation evidenced as follows: "i think that both of these components broke because of fatigue failure, and that the design of the frame resulted in load being focused on them, so that they were loaded beyond their design criteria.The use of a single full ring might have prevented this failure.It may have been better to insert all of the distal screws from the lateral side so that they could share the load".Based on the results of the technical evaluation performed on the returned ring and on the evidences deriving from the medical evaluation, orthofix (b)(4) can conclude that the problem that occurred is not devices related.Orthofix (b)(4) continues monitoring the devices on the market.Device not returned.
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Event Description
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The information initially provided by the local distributor indicates: product codes: 99-56-23120 (please refer to mfr report 9680825-2016-00053) & 1 bone screw, code and batch unknown (please refer to mfr report 9680825-2016-00054).Batch numbers: (b)(4) & unknown.Hospital name: (b)(6).Surgeon name: (b)(6).Date of surgery: (b)(6) 2016.Body part to which device was applied: femur.Surgery description: lengthening.Patient information: (b)(6), male, (b)(6).Problem observed during: clinical use on patient.Type of problem: device functional problem.Event description: "the patient had a tl hex fixator applied on the right femur for mainly correcting an "ipometria" of the femur of about 3-4 cm.The initial surgery was performed in (b)(6) using a total of 3 tl-hex rings: a 5/8 ring (200mm) opened posteriorly, connected by 4 simple threaded rods to a full ring (5/8 + 3/8, ring of 220 mm) positioned in slightly more proximal metaphyseal area, connected with 6 tl-hex struts to a 5/8 ring (220 mm) opened medially.Finally, the whole frame was connected to a femoral arch, using threaded rods and oblique supports.There were no positioning problems during surgery and also the gradual correction was successfully performed.After about 4 months from the surgery, when the correction was concluded and the patient was in consolidation phase, the surgeon - dr.(b)(6) - informed that a bone screw, positioned in metaphyseal region and anchored to the full ring (5/8 + 3/8), broke.Unfortunately the details of this screw (measure, code and batch) cannot be determined as the stem, which reports the code, was cut at the time of the initial surgery, while the threaded tip is still in the patient's bone.Potential batches (as shown on the labels of the intervention sheet) are: (b)(4) (corresponding to bone screw code 99-611540), (b)(4) (corresponding to bone screw code 99-612660), (b)(4) (corresponding to bone screw code 99-612660).As i began to collect and to request the first data to open a complaint concerning the bone screw, the surgeon sends me a second message in which he explains that the connection part of the 3/8 ring is completely broken.Fortunately a replacement part was available, to stabilize the frame without serious consequences on the patient.The surgeon told me that in this final consolidation phase, the patient was permitted to have "free load" as tolerated with the aid of two sticks type "canadian" to ensure equilibrium.The patient weighs about (b)(6), but has not been reported any falls or accidental impacts".The complaint report form also indicates: the devices failure did not have any adverse effects on patient.The surgery was completed with the used devices.The event did not lead to a clinically relevant increase in the duration of the surgical procedure.An additional surgery was not required.Copies of the operative reports are not available.Copies of the x-rays images are available.Patient current health condition: the patient is in good health conditions.On june 22, 2016, orthofix (b)(4) received the following additional information: the stem of the bone screw is not available.The tip of the bone screw is in the patient's bone, an intervention for its removal is not planned.Please also kindly refer to mfr report 9680825-2016-00053.(b)(4).
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Search Alerts/Recalls
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