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 12/07/2023 |
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 report.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It was reported that the unit was cutting too deep.The event occurred at an unknown time.There was no reported patient harm, or delay.Due diligence is in complete, no further information is available at this time.
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Manufacturer Narrative
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This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.Review of the most recent repair record determined the device was not cutting properly; the vespel bearings were loose, the control bar was not in the correct position, and the device was out of calibration at the 0 reading.The bearings and screws were replaced, the control bar was repositioned, and the device was properly calibrated 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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