Model Number N/A |
Device Problems
Failure to Cut (2587); Calibration Problem (2890)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/26/2023 |
Event Type
malfunction
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Event Description
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It was reported that the device is skipping during the graft and that it needs calibration.The event timing was during surgery.There is no harm or delay reported.No adverse events were reported as a result of this malfunction due diligence is complete and no additional information is available.
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Manufacturer Narrative
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This complaint is recorded by zimmer biomet under (b)(4).A follow up/ final report will be submitted once investigation is complete.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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Manufacturer Narrative
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Review of the most recent repair record determined the device was not cutting properly; the motor would not power on and the device was out of calibration.The motor, swivel, and lever were replaced and the device was properly recalibrated and resolved the reported issue.Dhr was reviewed and no discrepancies related to the reported event were found.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 event information available.
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Search Alerts/Recalls
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