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 were out of specification on the low end and the control bar was loose; the spring seal and internal retaining ring were not fully seated.The vespel bearings, semi-circle bearings, spring seal, and retaining ring 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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