One certain® gold-tite® hexed screw (iunihg) was returned for investigation.Visual inspection of the as returned product identified fracture confirmed at the threaded region.Therefore, based on the evaluation, device malfunction did occur and the reported event was confirmed following inspection.Dhr review was completed for the subject lot number.It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformances, which could have caused or contributed to the reported event was noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.A device history review was performed and no related nonconformance¿s were noted.Also a complaint history search was performed using our complaint handling system and there were no additional related complaints for this product lot.A singular root cause could not be determined.The following sections have been updated: expiration date, udi: (b)(4).Device evaluated by manufacturer: change "no" to "yes.".
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