| Model Number 99-T93025 |
| Device Problem
Mechanical Jam (2983)
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| Patient Problem
No Code Available (3191)
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| Event Date 10/04/2019 |
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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 193337 batch g001 before the market release.No anomalies have been found.The original lot, manufactured in 2017 was comprised of(b)(4)devices.(b)(4) of them have already been distributed to the market.Orthofix (b)(4) checked the internal records related to the controls made on the device code 99-t93025 batch ad1756 before the market release.No anomalies have been found.The original lot, manufactured in 2017 was comprised of (b)(4) devices.All of them have already been distributed to the market.Orthofix (b)(4) checked the internal records related to the controls made on the device code 99-t93025 batch b1291742 before the market release.No anomalies have been found.The original lot, manufactured in 2019 was comprised of (b)(4)devices.All of them have already been distributed to the market.Technical evaluation: the technical evaluation of the devices involved, received on 17 october 2019 is currently on going.Medical evaluation: the information made available on the case was sent to our medical evaluator.A preliminary medical evaluation was performed and will be finalized once the results of the investigation are available.As soon as the results of the investigation are available, orthofix (b)(4) will provide you with a follow up report.Orthofix (b)(4) continues monitoring the devices on the market.Please kindly refer also to mfr report number 9680825-2019-00072 and 9680825-2019-00074.
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Event Description
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The information provided by the local distributor indicates: hospital name: (b)(6).Surgeon's name: dr.(b)(6).Date of surgery: (b)(6) 2019.Body part to which device was applied: femur proximal.Surgery description: fracture treatment.Patient information: (b)(6), female, (b)(6), 168 cm.Problem observed during: clinical use on patient/intraoperative.Type of problem: device functional problem.Event description: screw extractor (ref 193337) got blocked in cephalic screw.This extraction of the lag screw was impossible with the extract device.When the device was put in (b)(6), as the lag screw was too short, the surgeon tried to extract it during (b)(6) surgery, with no success.So he probably damaged the lag screw thread during the first surgery.When they tried to extract the screw 3 months after, so last friday (b)(6), then couldn't get the tread.So they tried with the screw extractor (size 4-9mm) with the universal chuck to turn with no success.The screw extractor's thread and the lag screw thread completely cold welding.The complaint report form also indicates: the device failure had adverse effects on patient.The initial surgery was not completed with the device.A replacement device of same model was not immediately available to complete.Surgery: the surgery was completed with a hip protesis.The event led to a clinically relevant increase in the duration of the surgical.Procedure: longest anestesia.Timing of ablation longer than supposed.An additional surgery was not required.A medical intervention (outpatient clinic) was not required.Copies of the operative report are not available.Copies of the x-ray images are available (pre-operative images).Information about patient current health condition: ok.Further information received from the local distributor on 10th october 2019: the surgery of 4th was a replacement for protesis.The screw too short gave pain to the patient.Pain in the hip.She could walk properly.So the decide to change it by a protesis.(b)(4).
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Event Description
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The information provided by the local distributor indicates: hospital name: (b)(6).Surgeon's name: dr.(b)(6).Date of surgery: (b)(6) 2019.Body part to which device was applied: femur proximal.Surgery description: fracture treatment.Patient information: 80 year-old, female, 79 kg., 168 cm.Problem observed during: clinical use on patient/intraoperative.Type of problem: device functional problem.Event description: screw extractor (ref 193337) got blocked in cephalic screw.This extraction of the lag screw was impossible with the extract device.When the device was put in (b)(6), as the lag screw was too short, the surgeon tried to extract it during (b)(6) surgery, with no success.So he probably damaged the lag screw thread during the first surgery.When they tried to extract the screw 3 months after, so last friday (b)(6) of october, then couldn't get the tread.So they tried with the screw extractor (size 4-9mm) with the universal chuck to turn with no success.The screw extractor's thread and the lag screw thread completely cold welding.The complaint report form also indicates: the device failure had adverse effects on patient.The initial surgery was not completed with the device.A replacement device of same model was not immediately available to complete surgery: the surgery was completed with a hip protesis.The event led to a clinically relevant increase in the duration of the surgical procedure: longest anestesia.Timing of ablation longer than supposed.An additional surgery was not required.A medical intervention (outpatient clinic) was not required.Copies of the operative report are not available.Copies of the x-ray images are available (pre-operative images).Information about patient current health condition: ok.Further information received from the local distributor on 10th october 2019: the surgery of (b)(6) was a replacement for protesis.The screw too short gave pain to the patient.Pain in the hip.She could walk properly.So they decide to change it by a prosthesis.Manufacturer reference number: 2019190.Distributor reference number: 205.
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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 193337 batch g001 before the market release.No anomalies have been found.The original lot, manufactured in 2017 was comprised of (b)(4).26 of them have already been distributed to the market.Orthofix srl checked the internal records related to the controls made on the device code 99-t93025 batch ad1756 before the market release.No anomalies have been found.The original lot, manufactured in 2017 was comprised of (b)(4).All of them have already been distributed to the market.Orthofix srl checked the internal records related to the controls made on the device code 99-t93795 batch b1291742 before the market release.No anomalies have been found.The original lot, manufactured in 2019 was comprised of (b)(4).All of them have already been distributed to the market.Technical evaluation: the returned devices, received on 17th october 2019 were examined by orthofix srl quality engineering department.The devices were subjected to visual and dimensional check as per orthofix srl design and product specifications.The visual check confirmed that the screw extractor is locked in the cephalic screw.Screw and nail are damaged and the teeth of the screw are broken.The screw is partially extracted.The visual check did not evidence any bone residuals on the implant.Therefore, the issue experienced during extraction was not due to the bone ingrowth preventing the movement of the screw.The dimensional check did not evidence any anomalies.During the functional check the screw was removed from the nail by the application of an anti-clockwise torque with a control instrument corresponding to code ref.17955 universal chuck with t-handle, as stated in the applicable operative technique hf 1501 opt.After the removal of the screw from the nail it was evidenced that the teeth and hole of the nail are damaged.It was not possible to perform a complete functional check as the devices are damaged.Medical evaluation: the information made available on the case together with the results of the technical investigation, was sent to our medical evaluator.Please find below an extract of the medical evaluations: on (b)(6) 2019: in this case from france an 80 year old female patient of 79 kg sustained a basal femoral neck fracture in (b)(6) 2019 and was treated by internal fixation with a chimaera nail including a supplementary lag screw.The x-ray attached shows a main lag screw of good length with a slightly short supplementary lag screw.We are told that during the july operation the surgeon tried to remove the supplementary lag screw to insert a longer one, but was unable to do so.He therefore left it in place.The patient apparently had some pain, and the surgeon once again attempted to remove the supplementary lag screw to insert a longer one, but was again unable to do so.The screw extractor would not engage with the screw head.He therefore changed the fixation completely by removing all the implants and inserting a prosthesis.There was a problem with the screw extractor because the screw head had probably been damaged in the previous surgery.He therefore needed a generic screw extractor to remove the screw.My comments are as follows: we do not know the date of the one x-ray provided.In the x-ray it can be seen that the femoral head and neck have collapsed down until the base of the neck seems to be resting on the nail.We do not have a lateral view so cannot make any comment about the original reduction.I think that it is very likely that this patient's pain was due to a non union secondary to a collapse of the fracture with shortening.I do not think that the slightly short supplementary lag screw made any difference to the outcome and do not think that it caused the pain.A prosthesis is the correct solution in this type of case and the patient should do well.We need to see more x-rays including the original ones prior to fixation, and some laterals of the fixation to show the fracture position.We do not know how well it was possible to reduce the fracture.It is likely that failure to unite in this case was due to particular factors of the fracture and the position of the fixation.I think that it is likely that these events were not product related.This patient had persistent pain in her hip after a fractured neck of femur.The pain persisted almost certainly because the fracture failed to unite.The patient therefore had a prosthesis inserted.I do not think that this is a serious injury because of an implant; it is a sequence of events that have happened because a fracture failed to unite.The final treatment is the recognised solution to this problem.25 november 2019 with the outcome of the technical analysis: this technical analysis confirms that it was possible to remove the supplementary screw from this patient with the use of the correct amount of torque.The screw had not been inserted correctly as the teeth were not engaged as they should have been.We only have the ap x-rays and are therefore unable to comment on the lateral view, or the fracture in a preoperative film.We know that the fracture had collapsed down to the nail and that it would probably not have united, which is why the patient still had pain.I agree with the conclusion of the technical analysis.Final comments: the results of the technical evaluation evidenced that the devices were originally conforming to orthofix srl design specifications.During the functional check performed it was possible to extract correctly the lag screw from the nail using the screw extractor as indicated in the operative technique.The issue notified is most likely related to the incorrect initial positioning of the cephalic screw, which led to the locking of the screw-nail connection.Orthofix srl continues monitoring the devices on the market.Please kindly refer also to mfr report number 9680825-2019-00072 follow up 1 and 9680825-2019-00074 follow up 1.- attachment: [(b)(4)_fda medwatch cover letter follow up 1.Pdf].
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