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Device Problem
Failure to Cut (2587)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/17/2023 |
Event Type
malfunction
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Manufacturer Narrative
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This event is recorded with zimmer biomet under (b)(4).This medwatch is being filed as an initial / final report based on information discovered during the device evaluation.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Part and lot 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.Multiple mdr reports were filed for this event, please see associated report: 0001526350-2023-01182-1 h3 other text : product did not returned.
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Event Description
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It was reported that during surgery, the unit was taking skin in strips, fortunately wide enough to be implanted, but not the width of the blade.There was no patient harm or injury.There was no surgical delay.During device investigation, it was discovered that the blade may have attributed to the reported event.Due diligence is complete, no further information is available.
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Search Alerts/Recalls
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