This event is recorded by zimmer biomet under (b)(4).Review of the most recent repair record determined the rpms were not in specification, the control bar was not in the correct position, the calibration was not in at all readings, and the control bar was loose.The vespel and semi-circle bearings, motor and other parts 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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