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Catalog Number 04.027.017S |
Device Problem
Mechanical Jam (2983)
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Patient Problem
Failure of Implant (1924)
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Event Type
Injury
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Manufacturer Narrative
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Patient id/initials, age/date of birth and weight are unknown.Complainant part is not expected to be returned for manufacturer review/investigation.G5: device is not distributed in the united states, but is similar to device marketed in the usa.The investigation could not be completed; no conclusion could be drawn, as no product was received.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported the patient was implanted with a less invasive stabilization system (liss) and a proximal femoral nail anti-rotation (pfna) after a motorcycle accident in 2008, due to a complex multiple supply cut of the right thigh.The patient was free of symptoms.Recently the patient had a further accident where he had a collision with a tree trunk.The patient suffered a break to the thigh between the liss and pfna.An implant removal with new nailing was planned.During surgery, they were not able to remove the blade.The surgery was finished, and an additional surgery with additional instruments was successfully completed on (b)(6) 2017.Concomitant device: pfna nail (part 472.401s, lot 2519028, quantity 1).This is report 1 of 1 for (b)(4).
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Manufacturer Narrative
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Date of implant reported as 2008, exact date is not known.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Manufacturer Narrative
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A device history record (dhr) review was performed for part number: 04.027.017s, synthes lot number: 2618178: release to warehouse date: 29.Jun.2010 expiry date: 01.Jun.2020, manufacturing site: (b)(4): no non-conformance reports (ncrs) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Product was not returned.The device history record was researched; no abnormal findings were identified.Manufacturing and inspection records indicated no problems with the lot in question.Based on these findings we conclude that the cause of failure is not due to any manufacturing non-conformance.Based on the information available, this complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.The received pictures and x-ray confirm the issue as per event description; the complaint therefore has been determined to be confirmed.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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Device report from synthes europe reports an event in germany as follows: it was reported the patient was implanted with a less invasive stabilization system (liss) and a proximal femoral nail anti-rotation (pfna) after a motorcycle accident in 2008, due to a complex multiple supply cut of the right thigh.The patient was free of symptoms.On an unknown date in 2010, the patient had a further accident where he had a collision with a tree trunk.The patient suffered a break to the thigh between the liss and pfna.On (b)(6) 2017, patient had temporary stabilization via external fixation.On (b)(6) 2017, an implant removal with new nailing was attempted.During the surgery, the plate was removed.It was noted that three distal screws could not be loosened by hand and a fourth screw was broken.One of the three screws was removed with a hollow drill.While trying to remove the remaining two screws, the screw head is over-drilled and destroyed with the drill bit.Therefore, three screw remnants were left in the patient.During the surgery, various attempts were made to remove the pfna femoral neck screw but was not successful.Pfna blade remained in the patient.The surgery was stopped, and an additional surgery with additional instruments was successfully completed on (b)(6) 2017.Pfna blade was successfully removed.Concomitant device: pfna nail (part 472.401s, lot 2519028, quantity 1).This report is for one (1) pfna blade.This is report 1 of 3 for (b)(4).
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Updated event description.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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Device report from synthes europe reports an event in germany as follows:it was reported the patient was implanted with a less invasive stabilization system (liss) and a proximal femoral nail anti-rotation (pfna) after a motorcycle accident in 2008, due to a complex multiple supply cut of the right thigh.The patient was free of symptoms.On an unknown date in 2010, the patient had a further accident where he had a collision with a tree trunk.The patient suffered a break to the thigh between the liss and pfna.In 2010, a multilevel fracture of the right femur was treated synchronously with a proximal femoral nail and a femur liss plate.On an unknown date post-operative, patient suffered from a fracture of the femur with horizontal implants at the level of the pfna distal locking screw and at the level of the liss plate end, respectively.On (b)(6) 2017, patient had temporary stabilization via external fixation as the extraction instruments were not primarily available for the pfna.On (b)(6) 2017, an implant removal with nail removal set was attempted.During the surgery, the femoral neck screw could not be removed using the instruments available on nail removal set.In the meantime, the distal locking screw of the nail was removed.The proximal, mono-cortical screws could be completely removed from the plate.It was noted that three distal screws could not be loosened by hand and a fourth screw was broken.Using the special set for screws that could not be loosened, it was possible to unscrew one screw.In the case of the two other non-detachable screws, the screw heads were over-drilled and destroyed with the drill bit.The plate could then be removed.The free traction screws remain in the area of the condyles, together with three screw remnants, which protrude just above the lateral corticalis.Various instruments were used to try to grasp the ends of the screws and unscrew them, but this failed.A hollow drill was available for over-drilling the remaining screws.This was used for the most proximal screw.This made it possible to remove this screw, but the drill was no longer usable after that, so the two other screw remnants remained in place.During the surgery, various attempts were made to remove the pfna femoral neck screw but was not successful using the instruments available on the nail removal set.Pfna blade remained in the patient.The surgery was stopped, and an additional surgery with pfna expert blade extraction set was planned for next day, (b)(6) 2018.The surgery was completed after approximately two and a half hours of surgery time.Due to the extensive wound, there had been a significant loss of blood, resulting in transfusion.On (b)(6) 2018, with the help of the extraction set for blades, the extraction of the casing with an adapter for casing for the removal of pfna blades was attempted.This did not succeed.Then an attempt was made to use removal pliers, which, however, did not sufficiently clasp the protruding end of the screw.Finally, the blade was removed using a hook wire, which was inserted through the femoral neck screw and medially over the blade tip.With another kirschner wire the 1st wire was clamped in such a way that the hook at the end of the screw engages securely.With the help of an adapter, the wire was connected with a guide rod and a knock-out hammer.Only after numerous and intensive knock-out attempts, the screw was finally loosened and extracted together with the sleeve.The inspection of the casing suggested that the oval casing was jammed in the nail, which made removal so difficult.The nail itself could then be removed effortlessly with the extraction instrument.The former bed of the pfna was also chosen as the entry point for the ufn, so as not to further weaken the proximal femur through a new access via the piriform fossa.The resulting slight variation of a few degrees was accepted.The guide wire was over-drilled to 13.5 mm with the flexible drill.This was successful until beyond the 1st remaining screw.A nail with a length of 420 mm and a thickness of 11 mm was inserted with the insertion guide.However, it became stuck on the distal screw, so that it was not driven in further in order not to cause any separation of the distal femur.For this reason, a nail with a length of 380 mm was driven in.(b)(4) captured the incident regarding post-operative bent nail.Concomitant device: pfna nail (part 472.401s, lot 2519028, quantity 1).This report is for one (1) pfna blade.This is report 1 of 3 for (b)(4).
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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Device report from synthes europe reports an event in germany as follows:it was reported the patient was implanted with a less invasive stabilization system (liss) and a proximal femoral nail anti-rotation (pfna) after a motorcycle accident in 2008, due to a complex multiple supply cut of the right thigh.The patient was free of symptoms.On an unknown date in 2010, the patient had a further accident where he had a collision with a tree trunk.The patient suffered a break to the thigh between the liss and pfna.In 2010, a multilevel fracture of the right femur was treated synchronously with a proximal femoral nail and a femur liss plate.On an unknown date post-operative, patient suffered from a fracture of the femur with horizontal implants at the level of the pfna distal locking screw and at the level of the liss plate end, respectively.On (b)(6) 2017, patient had temporary stabilization via external fixation as the extraction instruments were not primarily available for the pfna.On (b)(6) 2017, an implant removal with new nailing was attempted.During the surgery, the plate was removed.It was noted that three distal screws could not be loosened by hand and a fourth screw was broken.One of the three screws were removed with a hollow drill.While trying to remove the remaining two screws, the screw head is over-drilled and destroyed with the drill bit.Therefore, three screw remnants were left in the patient.During the surgery, various attempts were made to remove the pfna femoral neck screw but was not successful using the instruments available on the nail removal set.Pfna blade remained in the patient.The surgery was stopped, and an additional surgery with pfna expert blade extraction set was planned for next day, (b)(6) 2018.The surgery was completed after approximately two and a half hours of surgery time.Due to the extensive wound, there had been a significant loss of blood, resulting in transfusion.On (b)(6) 2018, the blade was removed using a hook wire, which was inserted through the femoral neck screw and medially over the blade tip.After numerous and intensive knock-out attempts, the screw was finally loosened and extracted together with the sleeve.The inspection of the casing suggested that the oval casing was jammed in the nail, which made removal so difficult.The nail itself could then be removed effortlessly with the extraction instrument.The former bed of the pfna was also chosen as the entry point for the ufn, so as not to further weaken the proximal femur through a new access via the piriform fossa.The guide wire was over-drilled to 13.5 mm with the flexible drill.This was successful until beyond the 1st remaining screw.A nail with a length of 420 mm and a thickness of 11 mm was inserted with the insertion guide.However, it becomes stuck on the distal screw, so that it was not driven in further in order not to cause any separation of the distal femur.For this reason, a nail with a length of 380 mm was driven in.(b)(4) captured the incident regarding post-operative bent nail.Concomitant device: pfna nail (part 472.401s, lot 2519028, quantity 1).This report is for one (1) pfna blade.This is report 1 of 3 for (b)(4).
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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