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Model Number N/A |
Device Problems
Corroded (1131); Residue After Decontamination (2325)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
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Event Date 05/08/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).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.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.
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Event Description
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It was reported that during the initial operating room (o.R.) setup the nurse was handling the persona femoral provisionals and noticed black residue on her gloves.On the inside of the femoral provisionals black debris was noticed in all left and right femoral provisionals.All 5 sets were examined and all had the same black debris.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Correction,the initial alert date was (b)(6)2018.Complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned metal parts determined that they had scratches, water marks, and black staining/residue marks.Sem micrographs and eds elemental analysis of the debris on the femoral provisionals.The residue showed high concentration of (o, mn and cl) and the debris indication areas were mechanically smeared and were filled with debris which predominantly showed oxides and some areas showed cl, c, si, ca, and al.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no were trends identified.The root cause for the black residue on the returned instruments is attributed to a maintenance issue 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 spread on each and all the metallic 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.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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Manufacturer Narrative
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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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Manufacturer Narrative
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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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Event Description
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It was reported during initial operating room setup, the nurse handling the instruments discovered black residue on her gloves.Subsequently, there was noticed to be black debris on some of the instruments.There were five sets examined and all five sets had the same black debris.As a result of the event, the surgery was delayed 35 minutes.Multiple cases and instruments were returned for the reported issue, however it is unclear if these instruments contributed to the reported surgical delay.No additional patient consequences were reported, and the surgery was successfully completed.
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Search Alerts/Recalls
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