Product complaint # (b)(4).Complainant part is expected to be returned for manufacturer review/ investigation but has yet to be received.Reporter is a j&j representative.Without a lot number, the device history records review could not be completed as no product was 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.
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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.H10 additional narrative: h4.Device manufacture date.H6 - codes updated to imdrf codes.Visual inspection: the driving cap/threaded was returned and received at jrz pal.After physical review of the device, it was observed that device is broken from the threaded tip.Broken fragment was not received.Rest of the device shows scratches/normal wear consistent with the device use which would not contribute to the complaint condition.No other issues were observed with the complaint device.Dimensional inspection: complaint relevant dimensional analysis cannot be performed due to post manufacturing damage.Document/specification review: no design issues or discrepancies were identified.Conclusion: the complaint condition was confirmed for the driving cap/threaded.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 history lot - no ncr's were generated during production.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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