(b)(4).Complaint sample was evaluated and the reported event was confirmed.Sem / eds analysis of the debris found on the instruments was performed and observed that the various effected areas were filled with debris which predominantly showed oxides and some areas showed chlorine.Dhr was reviewed and no discrepancies relevant to the reported event were found.Review of the complaint history determined that no further action is required as no were trends identified.The root cause is attributed to a maintenance due to following reason.All the metallic instruments contained in the trays show water marks.Some of the chemical elements (ca, s, o) do not come from the instruments themselves, but could come from caso4 contained in hard water.The black residue is ¿uniformly¿ spread on each and all the instruments, which is only possible through contact with air and water.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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