Model Number N/A |
Device Problems
Dull, Blunt (2407); Failure to Cut (2587); Positioning Problem (3009); Patient Device Interaction Problem (4001)
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Patient Problems
Laceration(s) (1946); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/04/2023 |
Event Type
Injury
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Event Description
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It was reported that during surgery the blade that was placed in the dermatome did not cut evenly.It became like a left stripe in the middle.The machine and blade were changed; however, the same thing occurred.Different doctors used the dermatome, but all get the same result.It is like the blade isn¿t straight in the middle or if it is not sharp in the middle of the blade.There was no harm or delay reported.No adverse events were reported as a result of this malfunction.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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This complaint is recorded by zimmer biomet under (b)(4).A follow up/ final report will be submitted once investigation is complete.Multiple mdr reports were filed for this event, please see associated reports: 0001526350-2023-01027.G2: foreign country - sweden.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.
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Event Description
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There is no additional event information.
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Manufacturer Narrative
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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.
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Event Description
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There is no additional event infromation available.
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Manufacturer Narrative
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Associated report: 0001526350-2023-01027-2.Visual examination of the returned product identified the blades were unopened in original packaging.No visual defects or damages were found.Dhr was reviewed and no discrepancies related to the reported event were found.The root cause of the reported issue is attributed to a manufacturing and design 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.
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Search Alerts/Recalls
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