Model Number N/A |
Device Problems
Dull, Blunt (2407); Failure to Cut (2587)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/09/2023 |
Event Type
Injury
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Event Description
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It was reported that at unknown timing three blades from the same batch number were not very sharp and produced poor samples.There has been no report of harm or delay.Due diligence is in process.No additional information has been received.No adverse events were reported as a result of this malfunction.
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Manufacturer Narrative
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This event has been recorded by zimmer biomet under (b)(4).G2: foreign: france.Multiple mdr reports were filed for this event, please see associated report: 0001526350-2023-01288, 0001526350-2023-01291.Evaluation and investigation is in process.Once the investigation is complete, a supplemental report will be filed.H3 other text: device is not being returned.
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Manufacturer Narrative
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This event has been recorded by zimmer biomet under (b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001526350-2023-01288-2, 0001526350-2023-01291-2.
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Event Description
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It was reported that at post-mortem epidermal sampling three blades from the same batch number were not very sharp and produced poor samples.There was no patient involvement.Due diligence is complete.No additional information is available.
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Event Description
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Due diligence is complete and no additional information is available.
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Manufacturer Narrative
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This event has been recorded by zimmer biomet under (b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001526350-2023-01288-1, 0001526350-2023-01291-1.No product was returned or pictures provided; functional, visual, and/or 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 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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