Model Number N/A |
Device Problems
Failure to Cut (2587); Noise, Audible (3273)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/31/2023 |
Event Type
malfunction
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Manufacturer Narrative
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This event has been recorded by zimmer biomet under (b)(4).E1 telephone number with ext.: (b)(6).G2 foreign: united kingdom.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 at unknown timing the electric dermatome was making a high pitch tapping sound and it was not taking skin.There has been no report of harm or delay.Due diligence is in process.No additional information has been received.No adverse events were reported as a result of this malfunction.
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Event Description
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Due diligence is complete and no additional information is 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 determined the reported noise and cutting issues were not confirmed during evaluation; however, the motor speeds were unstable and the motor was corroded, which could effect the device functional performance.The motor was 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 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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