Product complaint # (b)(4).Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing 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.
|
It was reported that on (b)(6) 2021, the patient underwent for a femoral nail removal of titanium cannulated proximal femoral nailing system (tfna) due to tfna nail and fenestrated lag screw were broken.The nails were removed, and a total hip was implanted.The procedure and patient outcome are unknown.Concomitant device reported.Unknown distal locking screw (part# unknown, lot# unknown, qty unknown).Unknown end caps (part# unknown, lot# unknown, qty unknown).This complaint involves (2) devices.This report is for (1) 12/130 deg ti cann tfna 170 - sterile.This report is 1 of 2 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.Manufacturing location: monument.Manufacturing date: 19-jul-2019.Expiration date: 30-jun-2029.Part number: (b)(4), 12mm/130 deg ti cann tfna 170mm - sterile.Lot number: 12l3464 (sterile).Lot quantity: (b)(4).Production order traveler met all inspection acceptance criteria.Inspection sheet, in-process / inspect dimensional / final met all inspection acceptance criteria.Inspection sheet, tfna assembly inspection (b)(4) rev b met all inspection acceptance criteria.Packaging label log (pll) was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.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: component parts were not reviewed because the complaint condition of ¿removal due to an unknown reason¿ does not indicate breakage of the nail.Therefore, dhr review of the raw materials would not be relevant to the reported condition.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.Visual inspection: 12/130 deg ti cann tfna 170 - sterile (p/n: (b)(4), lot #: 12l3464 ) was returned and received at us customer quality (cq).Upon visual inspection, the tfna nail body was observed to be broken at the helical blade assembly slot.Additionally, scratches and discoloration was also observed on the device which could have potentially been caused during the explantation process.Device failure/defect identified? yes.Dimensional inspection: dimensional inspection could not be performed due to the post-manufacturing damage.Document/specification review: the current and manufactured revision of the following drawings were reviewed: ti cannulated trochanteric fixation nail - advanced, 130 deg.Complaint confirmed? yes.Investigation conclusion: the complaint condition could be confirmed for the returned device as the returned device was observed to be broken.The cracked device could have caused the complaint condition.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.The potential cause could be due to unintended forces applied to the device.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.H5.
|