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Model Number N/A |
Device Problems
Failure to Cut (2587); Patient Device Interaction Problem (4001)
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Patient Problem
Abrasion (1689)
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Event Date 05/09/2023 |
Event Type
Injury
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Event Description
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It was reported that dermatome blades damaged skin graft when taken during surgery.They tried four times changing blades and dermatome machine.They tried using blades with a different lot# with the same dermatome that caused the damaged graft and it worked therefore, they believe it was the dermatome blades with lot# 65531429 that was causing the problem.There was a surgical delay of 45 minutes.The harvest site did not need an unexpected medical intervention, such as sutures, however an additional unplanned skin graft was needed to complete the surgery.Due diligence is in progress for this complaint; to date no additional information or product has been received.
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Manufacturer Narrative
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An investigation into the reported event has been initiated under (b)(4).Once the investigation has been completed, a follow up report will be submitted with the investigation results and any actions taken by the manufacturer.The following additional reports are being submitted in regards to (b)(4): 0001526350-2023-00522, 0001526350-2023-00523, 0001526350-2023-00524.
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Manufacturer Narrative
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This event has been recorded by zimmer biomet under (b)(4).Visual examination of the provided picture identified the skin graft was incomplete at the center; the graft had a stripe of damage.However, the reported event cannot be confirmed as the product was not returned for evaluation and it cannot be confirmed this cutter produced the graft seen in the provided picture.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: 0001526350-2023-00522-1; 0001526350-2023-00523-1; 0001526350-2023-00524-1.H3 other text : product not returned.
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Event Description
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There is no additional information available.
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Search Alerts/Recalls
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