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.If the information is unknown, not available or does not apply.H10 additional narrative: b3: only event year is known.E1 initial reporter address line 1: (b)(6).E3: reporter is a j&j employee.H3, h4, h6: product code: 314.281.Lot number: 22p3667.Manufacturing site: (b)(6).Release to warehouse date:(b)(6) 2020.A manufacturing record evaluation was performed for the finished device lot and no non-conformance was identified.Visual analysis of the returned sample revealed that the guide shaft (part number: 507899) of the hold-sl f/scr f/lcp 4.5/5 was missing.No other issue was identified.A dimensional inspection for the hold-sl f/scr f/lcp 4.5/5 was not performed as it is not applicable to the complaint condition.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the hold-sl f/scr f/lcp 4.5/5 would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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.
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