Model Number N/A |
Device Problems
Unstable (1667); Failure to Cut (2587); Patient Device Interaction Problem (4001)
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Patient Problems
Abrasion (1689); Laceration(s) (1946)
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Event Date 08/14/2023 |
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.
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Event Description
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It was reported that during surgery the dermatome skipped during use.An additional skin graft was required from the patient to complete the procedure.Due diligence is complete.No additional information is available.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.Review of the most recent repair record determined the device was skipping; the motor speeds were erratic.The motor, spring seal, and various other parts were replaced and resolved the reported issue.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 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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