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 3012447612-2022-00004 through 3012447612-2022-00008.
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Corrections in d4: udi number, d9, and h3.Additional information in h4 and h6: component, investigation type, findings, and conclusions.Inspection the returned devices were examined.Visual inspection revealed minor damage to the screw drive of each closure top.Dhr review the dhr was reviewed.There are no indications of manufacturing issues which would have contributed to this event and the device was likely conforming when it left zimmer biomet¿s control.Potential root cause a definitive root cause cannot be determined with the information provided.This event could possibly be attributed to off axis forces or incomplete insertion of drive mechanism during final torqueing.Device usage: this device is 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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