Model Number N/A |
Device Problems
Material Frayed (1262); Material Split, Cut or Torn (4008)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/02/2023 |
Event Type
malfunction
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Manufacturer Narrative
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This event has been recorded by zimmer biomet under cmp (b)(4).Foreign: uk.Once the investigation is complete, a follow up/final report will be submitted.
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Event Description
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It was reported that outside the surgical environment the lead of the dermatome was found clearly damaged and needs repair.There was a big cut on the lead.The wire inside was visible but it was not coming out.There was no patient involvement.Due diligence is complete and there is no additional information.No adverse events were reported as a result of this malfunction.
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Event Description
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No additional event information available.
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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 identified no repairs related to the reported event.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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