(b)(4).Report source: (b)(6).Product is in process of being returned to zimmer biomet for the 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 - 01965, 0001825034 - 2020 - 01970, 0001825034 - 2020 - 01971, 0001825034 - 2020 - 01972, 0001825034 - 2020 - 01973.
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Evaluation of the photographs provided confirmed the sterile packaging (blister and foam) is damaged and there is debris inside the sterile packaging which is consistent with the appearance of foam debris from the foam packaging inside the sterile barrier.Sterility was not compromised.Dhr was reviewed and no discrepancies were found.The investigation has concluded that the root cause of the reported event is likely to be damage during transit causing the foam packaging to become abraded and shed.The device evaluation found no malfunction and the event did not contribute to injury, therefore this would not be considered a reportable 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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