Model Number N/A |
Device Problems
Dull, Blunt (2407); Failure to Cut (2587); Patient Device Interaction Problem (4001)
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Patient Problem
Physical Asymmetry (4573)
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Event Type
Injury
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Event Description
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It was reported that during an unknown time the blade was not sharp and there was difficulty getting a sample of skin.It was necessary to increase the sampling surface.Due diligence is in process, and there is no additional information available.
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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.Multiple mdr reports were filed for this event, please see associated reports: 0001526350-2023-01422.G2 country: france.
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Manufacturer Narrative
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This complaint is 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.
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Event Description
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There is no additional information available regarding the event.
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Search Alerts/Recalls
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