Model Number N/A |
Device Problems
Failure to Cut (2587); Power Problem (3010)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/17/2022 |
Event Type
malfunction
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Event Description
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It was reported that outside of surgery the device had intermittent speed issues while in use.There was no harm.No adverse events were reported as a result of this malfunction.No further information is available.
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Manufacturer Narrative
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This event is recorded with zimmer biomet under (b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
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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.Tech confirmed the unit motor speed was out of specification on the low end.The motor, plug harness, and switch were replaced.The unit was tested, calibrated, and returned to the customer.Review of the device history record identified no deviations or anomalies during manufacturing.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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Manufacturer Narrative
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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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There is no additional event information available.
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Search Alerts/Recalls
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