Model Number N/A |
Device Problems
Loss of Power (1475); Intermittent Loss of Power (4016)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/26/2023 |
Event Type
malfunction
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Manufacturer Narrative
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This event is recorded with zimmer biomet under (b)(4).This medwatch is being filed as an initial / final report based on information discovered during the device evaluation.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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Event Description
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It was reported that during surgery the unit stops and starts, breaks during cut.There was no reported patient harm, or delay.Due diligence is complete, no further information is available at this time.
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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.The reported stop/start and cutting issue could not be replicated.The device passed all functional testing; no problem found.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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