Model Number N/A |
Device Problem
Fracture (1260)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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Zimmer biomet complaint (b)(4).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 that the wire cutters have a fractured tip and the damage was noticed during a case.The procedure was completed with a back up instrument.No adverse events were reported as a result of the malfunction.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The complaint is confirmed.A visual inspection was conducted on the cutter.The cutter shows signs of wear including scratching on the cutter surface.The cutter's cutting tip has a slight chip and as a result the cutters will no longer cut properly.The dhr was reviewed and there were no non-conformances found.There are no indications of manufacturing defects.This is the only complaint in regards to the instrument being chipped for 51-0929 lot 051319e19.The most likely underlying cause of the complaints is that excessive force was used, beyond what the instrument was designed to encounter.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Event Description
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This follow-up report is being submitted to relay additional information.
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Search Alerts/Recalls
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