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Model Number N/A |
Device Problems
Material Integrity Problem (2978); Naturally Worn (2988); Appropriate Term/Code Not Available (3191)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/24/2023 |
Event Type
malfunction
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Event Description
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It was reported that the following unit was sent in for maintenance but found in need of repair due to a worn reciprocation arm, defective motor, damaged accessory return, and a damaged tray.Evaluation discovered that rpms were unstable.There was no harm or delay reported.No adverse events were reported as a result of this malfunction.Due diligence is in progress.No additional information is available at this time.
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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 determined that during preventative maintenance it was found that the motor speed was unstable, and the reciprocating arm was worn.The motor and reciprocating arm were replaced and resolved 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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Search Alerts/Recalls
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