This event has been recorded by zimmer biomet under (b)(4).G2 foreign: australia.The investigation is complete.This is an initial final report submission.Review of the most recent repair record determined the unit had very low rpm and was out of calibration.The motor, motor sleeve, planet gears, ring gear, needle bearing, lever, spring pin, spring and swivel 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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