This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: d4; d9; g3; h2; h3; h4; h6 the reported event is confirmed.Sterility has not been compromised as the sterile barriers are intact.Evaluation of the returned products confirmed damage to the sterile packaging blister and 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.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.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.Upon further investigation, it has been determined that the packaging meets the acceptable criteria specifications and the sterility has not been breached.This event is no longer considered reportable.Therefore, the initial report 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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