(b)(4).Report source: (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-03052, 0001825034-2020-03054, 0001825034-2020-03055, 0001825034-2020-03058, 0001825034-2020-03059.
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This follow-up report is being submitted to relay additional information.Evaluation of the returned product/photographs provided confirmed the following: lot #3595180; 3518435: debris inside the sterile packaging which is consistent with the appearance of foam debris from the foam packaging inside the sterile barrier.Lot #3730519: debris inside the sterile packaging which is consistent with the appearance of the porous coating inside the sterile barrier.Lot #3760677; 3011826; 3746966: debris inside the sterile packaging which is consistent with the appearance of the porous coating and foam debris from the foam packaging inside the sterile barrier.The reported event is confirmed.Device history record (dhr) was reviewed and no discrepancies were found.The likely condition of the product when it left zimmer biomet was conforming to specification.The root cause of the reported event is likely to be due to transit damage.Upon receipt of additional information, it has been determined no serious injury was reported as a result of this malfunction.Additionally, this malfunction has not previously been reported for having caused a serious injury on a same/similar device in the past.The initial report was forwarded in error and should be voided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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