This event is recorded by zimmer biomet under (b)(4).Review of the most recent repair record determined the 2 in width plate, head, and reciprocating arm were damaged.The width plate, screws, seal gland, bearing, and reciprocating arm 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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It was reported that during processing that the dermatome attachment was observed to be chipped.After evaluation of the returned device, it was determined that the device had a damaged width plate.There was no harm, injury, or delay as there was no patient involvement.Due diligence is complete.No additional information is available.No adverse event.
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