Catalog Number 00880000010 |
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 12/02/2022 |
Event Type
Injury
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Event Description
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It was reported that the device skipped causing only a part of the skin to be taken off.The event occurred during surgery.There was no delay.There was an additional graft needed.Due diligence is complete.
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Manufacturer Narrative
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This complaint is recorded by zimmer biomet under (b)(4).A follow up/ final report will be submitted once investigation is complete.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 trend.
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Event Description
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There is no additional event information.
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Manufacturer Narrative
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This complaint is 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.A definitive root cause cannot be determined.The event cannot be 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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Search Alerts/Recalls
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