Device Problems
Failure to Cut (2587); Power Problem (3010); Pressure Problem (3012); 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 there was difficulty getting a sample of skin and the dermatome didn't have adequate pressure or sufficient cutting speed and 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: 0001526350-2023-01420.G2 country: france.
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Event Description
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There is no additional information available regarding the event.
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Manufacturer Narrative
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This complaint is recorded by zimmer biomet under (b)(4).Review of the most recent repair record could not be completed because the device was not returned for evaluation and repair.Part and lot/serial identification are necessary for review of device history records, neither were provided.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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Search Alerts/Recalls
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