Product complaint # (b)(4).This medwatch was submitted late as the prior medwatch was stuck in transmission.On ((b)(6) 2022) the fda notified depuy synthes that the report needed to be resubmitted.Please reference fda ticket csh-28330 for additional details.Investigation summay: the device associated with this report was returned.After physical review, it was identified that a portion of the outer perimeter is broken.Also, several scratches throughout the piece were found.The allegation is confirmed.No other issues were observed.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.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 information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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