Model Number N/A |
Device Problems
Failure to Cut (2587); Patient Device Interaction Problem (4001)
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Patient Problem
Laceration(s) (1946)
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Event Date 08/08/2023 |
Event Type
Injury
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Manufacturer Narrative
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This event has been recorded by zimmer biomet under (b)(4).Evaluation and investigation is in process.Once the investigation is complete, a supplemental report will be filed.H3 other text : device is not being returned.
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Event Description
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It was reported that during surgery the device was not cutting correctly and left skin patterns.This created a wound on the patient and wasted skin as well.There was no delay noted.Due diligence is in process and there is no additional information presently available.No additional consequences have been reported as a result of this malfunction.
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Event Description
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It was reported that during surgery the device was not cutting correctly and left skin patterns.This created a wound on the patient.An additional skin graft was required from the patient.Due diligence is in complete; no additional information available at this time.No additional consequences have been reported as a result of this malfunction.
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Manufacturer Narrative
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This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.Once the investigation is complete, a follow up/final report will be submitted.
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Manufacturer Narrative
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This event has been recorded by zimmer biomet under (b)(4).No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.The root cause of the reported issue is attributed to a manufacturing and design issue.The event is confirmed.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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No additional event information available.
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Search Alerts/Recalls
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