It was reported during initial operating room setup, the nurse handling the femoral provisional had black residue on her gloves.There was noticed to be black debris on the inside of the left and right femoral provisional.There were five sets examined and all five sets had the same black debris.As a result of the event, a delay in procedure occurred approximately 35 minutes long.No additional patient consequences were reported.
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This follow-up report is being submitted to relay additional information.The actual device was not returned for evaluation; however, a complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned parts determined that they had scratches suggesting repeated use.Sem micrographs and eds elemental analysis of the debris on the femoral provisionals was conducted and it was found that rust like indication on the laser etched areas which showed high concentration of (o- oxygen, mn-manganese and cl-chlorine) and the debris indication areas were mechanically smeared and were filled with debris which predominantly showed oxides and some areas showed chlorine- cl, carbon-c, silicon- si, calcium-ca and aluminum-al.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.Investigation results concluded that the reported event was due to maintenance issue as some of the chemical elements do not come from the instruments, but could come from hard water.The black residue is spread on each and all the instruments, which is only possible through contact with air and water.The recommended cleaning steps were not followed based on the provided information.This issue only occurred for 1 set out-of 740 sets distributed worldwide in 2017, and in one location where the sterilization equipment of the hospital underwent maintenance one week prior to the issue.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.The actual device was not returned and the date should be blank.
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