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Model Number N/A |
Device Problems
Corroded (1131); Component Missing (2306); Calibration Problem (2890); Naturally Worn (2988)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/19/2022 |
Event Type
malfunction
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Event Description
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It was reported that this unit was returned for maintenance, but repair was needed as there was a calibration issue, worn reciprocation arm, worn ball bearing, missing hinge, corroded ball bearings, and a defective motor.Evaluation of the device later found that the motor speed was unstable.There was no patient involvement.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).Telephone number: +49 (0)7634 508 4361.Review of the most recent repair record determined the motor speeds were unstable, the ball bearing was corroded, the reciprocating arm and ball bearing were worn, and the device was out of calibration.The motor, hinge gasket, reciprocating arm, and ball bearing were replaced and the device was recalibrated and resolved the reported issue.Dhr was reviewed and no discrepancies related to the reported event were found.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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