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 Date 11/04/2022 |
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 testing prior to the surgery, the device was not cutting properly.No adverse event occurred as there was no patient harm.Due diligence is complete, and no additional details are available.
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Manufacturer Narrative
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This complaint is recorded by zimmer biomet under: (b)(4).Evaluation of the returned device found the rpms were below specifications, the control bar was in the wrong position, and the device was out of calibration.The unit was scrapped following evaluation.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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No additional information is available regarding the incident.
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Search Alerts/Recalls
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