Model Number N/A |
Device Problem
Failure to Cut (2587)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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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 device shredded skin.There was no patient impact and no delay during the procedure.Due diligence is complete and there is no additional information available.There was no adverse event associated with the malfunction.
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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 determined the neckpiece was broken and the control bar was not in the correct position.The neckpiece, reciprocating arm and other worn parts were replaced and resolved the reported issue.Review of the device history record identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.The event is 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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