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).(udi #): (b)(4).Report source: (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, a delay in procedure occurred approximately 35 minutes long.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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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 and it was found that rust like indication on the laser etched areas which 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 relevant to the reported event were found.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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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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Search Alerts/Recalls
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