Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.Reference reports 3012447612-2022-00084 through 3012447612-2022-00085.
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Corrections in d4: udi number, d9, and h3.Additional information in h4 and h6: component, investigation type, findings, and conclusions.Device evaluation: visual inspection revealed no damage to either the hex drive or the threads.Potential cause root cause was unable to be determined as no product issue was found.Dhr review per dhr review, the parts were likely conforming when they left zimvie control.Device use these devices are used for treatment.If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.
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