Model Number N/A |
Device Problem
Physical Resistance/Sticking (4012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/24/2023 |
Event Type
malfunction
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Manufacturer Narrative
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This event has been recorded by zimmer biomet under (b)(4).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 the air dermatome was getting stuck during use.There was no harm or delay reported.Due diligence is complete and no additional information is available.No adverse events were 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).Review of the most recent repair record identified no related findings/repairs to the reported event.The reported issue could not be replicated and the swivel, motor and motor sleeve were replaced as a precaution.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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Event Description
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No additional event information available.
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Search Alerts/Recalls
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