Model Number N/A |
Device Problem
Material Twisted/Bent (2981)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/08/2023 |
Event Type
malfunction
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Event Description
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It was reported that during decontamination, it was observed that the blade was bent.There was no patient involvement.Due diligence is complete and there is no additional information available.There was no adverse event associated with this 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.Telephone number: (b)(6).
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Manufacturer Narrative
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This event has been recorded by zimmer biomet under (b)(4).Review of the most recent repair record determined the motor rpms were noisy and the thickness control bar was loose.The spring seal, internal retaining ring, vespel bearing, and semi-circle bearing were replaced and resolved the reported issue.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.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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No additional event information available.
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Search Alerts/Recalls
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