This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4, b5, g3, g6, h2, h3, h6, h10.Evaluation of the returned products confirmed damage to the sterile packaging pouch, and there is debris inside the sterile packaging which is consistent with the appearance of porous coating, and foam debris from the foam packaging inside the sterile barrier.Sterility has not been compromised.Device history record was reviewed and no discrepancies relevant to the reported event were found.The likely condition of the products when they left zimmer biomet was conforming to specifications.The root cause of the reported event is likely due to transit damage.This is no longer considered a reportable event.A corrective action has been opened to further investigate this event.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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