Model Number N/A |
Device Problems
Failure to Cut (2587); Patient Device Interaction Problem (4001)
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Patient Problems
Abrasion (1689); Scar Tissue (2060)
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Event Date 03/31/2022 |
Event Type
Injury
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Manufacturer Narrative
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This complaint has been recorded under (b)(4).Once investigation is completed a supplement/final report will be submitted.
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Event Description
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It was reported that during surgery the device did not harvest graft successfully.Graft was torn and had areas where device did not cut all the way.An additional graft was needed and harvest adding an unknown amount of time to surgery.No additional adverse events were reported as it relates to this event.
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Manufacturer Narrative
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This incident has been recorded under (b)(4).Review of the most recent repair record could not be completed because the device was not returned for evaluation and repair.Review of the device history record identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.The event cannot be 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 trend.
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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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