It was reported that during surgery there was a gap in between the blade and blade guard causing vibration and created a bad skin graft.The graft was not damaged.There was no patient harm or injury.There was no medical intervention, or and no additional surgery/graft procedure required.There was no surgical delay.Another device was used to complete the surgery.Due diligence is complete, no further 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: b4, b5, d2, d4, g1, g3, g6, h1, h2, h3, h4, h6, and, h10.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.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.Multiple mdr reports were filed for this event, please see associated report: 0001526350-2024-00021 h3 other text : product was not returned.
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