Model Number N/A |
Device Problems
Unstable (1667); Intermittent Loss of Power (4016); Excessive Heating (4030)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/26/2023 |
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 during surgery the device would start, but has irregular speed and then slowly loses speed until it stops and then will not restart.Device feels warm afterwards.No harm reported.The graft harvest was able to be used.There was a surgery delay 16-30 minutes.Due diligence is complete.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).G2 foreign: australia.This medwatch is being filed to relay additional information.Review of the most recent repair record determined the motor ran below specification.The motor, needle bearing, and reciprocating arm were replaced to resolve 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 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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Search Alerts/Recalls
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