This event has been recorded by zimmer biomet under (b)(4).The investigation is complete.This is an initial final report submission.Review of the most recent repair record determined the rpms could not be checked due to exposed wires and there were worn components.The motor, switch, switch mount, plug harness assembly, screws, seals, bearings, thickness control shaft, reciprocating arm, and eccentric shaft were replaced.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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