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 and the width plate, which the account thinks is the reason for certain vibration (bouncy, as the account described) resulting in a bad skin graft.There was random skipping of graft.There was no patient harm or injury.There was no surgical delay, and no indication of another graft being taken.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.The root cause of the reported issue is attributed to manufacturing issue.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: 0001526350-2024-00061.
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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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