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 3012447612-2021-00463 through 3012447612-2021-00467.
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Corrections in d4: lot number and udi number, d9, h3, and h4.Additional information in h6: component, investigation type, findings, and conclusions.Device evaluation the returned devices match the information in the complaint file and were examined.There were five returned closure tops, however one was lost in the wash process (lot j6427145) and is unable to be inspected.The four that were able to be inspected revealed stripped hex on three (lot numbers j6364237, j6392969 and j6435242) and one with damaged threads (lot j6364237).Potential cause: root cause was unable to be determined.This event could possibly be attributed to applying off-axis forces during insertion.Dhr review: per dhr review, the parts were likely conforming when they left zimmer biomet control.Device use: this device is used for treatment.A follow-up report will be submitted if new information is received that changes the information provided in this report.
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