|
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.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.(b)(4).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.
|
|
Device report from (b)(6) reports an event as follows: it was reported that on (b)(6) 2019, a patient underwent re-operation due to non-union and the breakage of a trochanteric femoral nail advanced (tfna) nail at the helical blade hole.The tfna implants were removed and patient was revised to an artificial bone head.Initially, the patient had an open reduction internal fixation (orif) surgery with tfna long system for femoral subtrochanteric fracture on (b)(6) 2018.However, the patient complained of pain during the postoperative follow-up observation.Images were taken on (b)(6) 2019 and showed the non-union and the breakage of the tfna nail.The procedure was successfully completed, though the operation caused an additional burden to the patient due to hospitalization, anesthesia, incision and blood transfusion.There was no surgical delay.Patient status is unknown.The surgeon commented that there was a possibility that stress was concentrated to the implants due to nonunion causing the breakage of the nail and strongly suspected that the event was caused by the metal material of the nail.Concomitant devices: tfna helical blade 95 mm (part: 04.038.295s, lot: h628449, quantity: 1), 5.0 locking screw 34 mm (part: 04.005.524s, lot: l531829, quantity: 1), 5.0 locking screw 34 mm (part: 04.005.524s, lot: l853295, quantity: 1), 1.7 cable with crimp 750 mm (part: 611.105.01s, lot: p285606, quantity: 1).This report is for a 11 mm/125 degree titanium (ti) cannulated tfna nail.This is report 1 of 1 for (b)(4).
|
|
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.H3, h4, h6: a device history record (dhr) review was conducted: manufacturing location: monument, manufacturing date: 22-feb-2016, expiration date: 01-feb-2026, part number: 04.037.120s, 11mm/125 deg ti cann tfna 300mm/right- sterile, lot number: h038380 (sterile), lot quantity: 5.This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Component part(s) reviewed: part number: 04.037.912.2, lock prong, 125 degree tfna, bp55, lot number: 9668051, lot quantity: 96.Work order travelers met all inspection acceptance criteria.Part number: 04.037.912.4, wave spring, shim ended, bp55, lot number: 7921070, lot quantity: 1,000.Work order travelers met all inspection acceptance criteria.Part number: 04.037.912.3, tfna lock drive, bp58, lot number: 9963806, lot quantity: 80.Work order traveler met all inspection acceptance criteria.I part number: 21127, timoagri16.00, bp80, lot number: 7926421, lot quantity: 1,828 lbs.This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.H3, h6: a product investigation was conducted.Visual inspection: the tfna nail was received at the us cq.The device had fractured about the helical blade hole at the proximal end of the device and was received in two fragments.Both fragments were scuffed and scratched.The distal fragment had nicks in two of its screw holes at its distal end.The fracture of the device was jagged, and when the fragments were pieced together, it was observed that small fragments of material were missing.The inner lock subcomponent had broken, and the distal fragment of the subcomponent was not received.The device failure/defect was identified.Dimensional inspection: proximal fragment outer diameter proximal to fracture and distal fragment outer diameter proximal to fracture were measured and is withing specifications per relevant drawings.Conclusion: the complaint was confirmed for the tfna nail.The device had broken in two (2) pieces about the opening for a helical blade at the proximal end.Both fragments had been scuffed and scratched.The distal fragment was nicked in its screw openings.The inner lock subcomponent was also broken, with the distal fragment missing.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.No definitive root cause could be determined, but the device possibly encountered unintended forces.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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.
|
