(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-00208, 0001825034-2017-00210, 0001825034-2018-04188, 0001825034-2018-04189, 0001825034-2018-04191 complaint sample was evaluated and the reported event was confirmed.Visual inspection confirms the complaints as there is oxidation over all surfaces of the instruments.The products were sent to sem lab for material composition.It was identified that the driver shaft and handles composition were consistent with specification.Device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.A summary of the investigation has been sent to the complainant.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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