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, a delay in procedure of thirty-five minutes occurred.No additional patient consequences were reported.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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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Search Alerts/Recalls
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