It was reported that during surgery, the unit was not maintaining power, sounds like it is dying.There was no harm or delay reported.An alternate device was available for immediate use.There are no adverse events associated with this malfunction.Due diligence is complete, there is no additional information available.
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This event has been recorded by zimmer biomet under (b)(4).The following sections have been updated: b4, b5, d2, d4, g1, g3, g6, h1, h2, h3, h4, h6, and h10.Review of the most recent repair record determined the rpms were not constant.The motor, plug harness assembly, motor seal, spring seal, and needle bearing 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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