It was reported that during surgery on (b)(6) 2023 the air dermatome lever loose when unlock.Skin graft unable to harvest properly causing a broken graft.There was no reported patient harm, or delay.Due diligence is complete, no further information is available at this time.
|
This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.Review of the most recent repair record determined the rpm reading was 0 and the device was out of calibration.The motor, spring seal, needle bearing, reciprocating arm, control bar assembly, hinge throttle gasket, and etched lever 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.
|