Model Number N/A |
Device Problems
Failure to Cut (2587); Output below Specifications (3004)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/31/2022 |
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 an evaluation of this device is completed, a follow-up/final report will be submitted.
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Event Description
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It was reported that this dermatome does not cut at all and rpm is low.Occurred during surgery and there was no harm or delay.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.
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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 that the motor speed was unstable, the unit was out of calibration, and the position of the control bar was not correct.The unit was recalibrated and the motor was replaced to resolve the reported issue.Dhr was reviewed and no discrepancies related to the reported event were found.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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Search Alerts/Recalls
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