Model Number N/A |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Information (3190)
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Event Date 05/08/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).(b)(6).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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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, the surgery was delayed 35 minutes.No additional patient consequences were reported.
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Manufacturer Narrative
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This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Additional: updated corrected conclusion code.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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This follow-up report is being submitted to relay additional information.Complaint samples were evaluated and the reported event was confirmed.Examination of the returned parts found scratches on many of the tray components, suggesting repeated use.Sem / eds analysis of the debris found on the cut guides was performed and observed that the various effected areas were filled with debris which predominantly showed oxides.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 is attributed to a maintenance 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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Search Alerts/Recalls
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