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 Type
Injury
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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.
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Event Description
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It was reported on an unspecified date, during surgery, the graft was damaged by bad blades.They used what was usable from the graft taken, however an unplanned additional graft was required.There was no medical intervention such as sutures required.There was a surgical delay of an unspecified time.Due diligence is in progress for this complaint; to date no additional information or product has been received.
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Event Description
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There is no additional information available.
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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 pictures 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 the 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.H3 other text : product not returned.
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Search Alerts/Recalls
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