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Model Number N/A |
Device Problem
Noise, Audible (3273)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/20/2023 |
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.Review of the most recent repair record identified the following related repair: the motor speed was low.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.G2: foreign: taiwan.
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Event Description
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It was reported that during kit inspection, the handpiece appeared noisy while depressing throttle.There was no patient involvement.During device evaluation, it was discovered that the motor speed was low.Due diligence is complete, no further information is available.
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Search Alerts/Recalls
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