Model Number N/A |
Device Problems
Vibration (1674); Failure to Cut (2587); Positioning Problem (3009)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/22/2023 |
Event Type
malfunction
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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 that during surgery, there was a gap between the blade being questioned, causing vibration and creating a bad skin graft.There was no patient harm/injury.The taken skin graft was damaged.There was no surgical intervention, and an additional unplanned skin graft was not needed.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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Manufacturer Narrative
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This event has been recorded by zimmer biomet under (b)(4).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: 0001526350-2024-00049 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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