It was reported that during preventative maintenance, the device was in need of repair due to the motor speed being unstable, damaged cable, and corroded motor.There was no patient involvement.Due diligence is complete and there is no additional information available.There was no adverse event associated with the malfunction.
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This complaint is recorded by zimmer biomet under cmp-(b)(4).Following sections were updated or corrected: b4, b5, d2, d4, g1, g3, g6, h1, h2, h3, h4, h6, and h10.Review of the most recent repair record determined the motor speed was unstable, the motor was corroded and the insulation of the cable was damaged (no exposed metal wires).The plug harness assembly and motor were replaced and resolved the reported issue.Review of the device history record identified no deviations or anomalies during manufacturing.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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