Model Number N/A |
Device Problems
Incorrect, Inadequate or Imprecise Result or Readings (1535); Failure to Cut (2587)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/24/2021 |
Event Type
malfunction
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Manufacturer Narrative
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This event has been recorded by zimmer biomet under (b)(4) once the investigation is completed, a follow-up/final report will be submitted.
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Event Description
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It was reported that during surgery the device took a thicker than expected graft.No harm or delay has been noted to have occurred.No additional adverse event was reported as it relates to this event.
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Manufacturer Narrative
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This complaint has been submitted under (b)(4).Review of the most recent repair record determined that the control bar was not in the correct position and the unit was out of calibration.The control bar was repositioned, and the unit was recalibrated to resolve the reported issue.Review of the device history records 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 information is available.
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Search Alerts/Recalls
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