It was reported that during surgery when activating the machine there was a noticeable variation in the speed.When trying to harvest, the blade stopped vibrating, and surgeon was unable to harvest.A split-thickness skin graft (stsg) was not able to be obtained; therefore, a full thickness graft had to be harvested manually from the patient.There was significant delay of an unspecified amount of time, and the patient was under general anesthesia.No additional patient consequences were reported.Due diligence is complete as the customer indicated that no additional information is available.
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This event has been recorded by zimmer biomet under (b)(4).The following sections have been corrected/updated: a2, a3, a4, b4, b5, d2, d4, d9, g1, g3, g6, h1, h2, h3, h4, h6, and h10.Review of the most recent repair record could not be completed because the device was not returned for evaluation and repair.The work order was cancelled as "problem cleared itself." 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 cannot be 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.H3 other text : product not returned.
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