Model Number N/A |
Device Problem
Failure to Cut (2587)
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Patient Problems
Physical Asymmetry (4573); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/07/2023 |
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, the blade malfunctioned causing the patient's skin graft donor site to be patchy and uneven.There was no note of patient harm or delay.Due diligence is in process and there is no additional information available.
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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; 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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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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