Catalog Number 2155-1 |
Device Problem
Material Twisted/Bent (2981)
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Patient Problem
No Information (3190)
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Event Date 03/04/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.Reference report 3012447612-2020-00195.
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Event Description
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It was reported that the tips of two drivers were found bent during an inspection.Therefore, there is no surgical or patient information available.This is report one of two for this event.
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Manufacturer Narrative
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(b)(4).D11 - medical product: catalog #: 2155-1, universal driver, lot # 66wh.Reported event was considered confirmed from visual inspection which revealed one of the prongs on each device was bent.Device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause could not be determined.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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No further event information available at the time of this report.
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Search Alerts/Recalls
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