(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 -01800, 0001825034-2020 -01801, 0001825034-2020 -01802, 0001825034-2020 -01803, 0001825034-2020 -01805.
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This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: d4; d11; g4; h2; h3; h4; h6 complaint sample was returned and evaluated against the reported event.Six boxes were returned and evaluated.Upon visual inspection the returned boxes have loose white debris inside of the clear plastic packaging.The sterile barrier is intact.Dhr was reviewed and no discrepancies were found.The root cause of the reported event is likely due to 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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