This event has been recorded by zimmer biomet under (b)(4).Associated dermatome report: 0001526350-2023-01314.No product was returned or pictures provided; functional, visual, and/or dimensional evaluations could not be performed.Lot identification is necessary for review of device history records, and lot identification was not provided.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 : requested but not returned by hospital.
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It was reported during the procedure the surgeon went to harvest the graft, and the cut was incomplete.Another dermatome was requested.The donor site on the patient was noted to have intact skin in the middle of the site indicative of the dermatome blade not engaging the skin.The skin from the pass was also torn and did not come off in one uniform piece.The procedure was aborted, and an additional surgery occurred seven days later.An additional unplanned graft was taken.Due diligence information complete.Due diligence information complete.No additional information is available.
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