Model Number N/A |
Device Problems
Failure to Cut (2587); Patient Device Interaction Problem (4001)
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Patient Problem
Laceration(s) (1946)
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Event Type
Injury
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Event Description
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It was reported that during surgery an incomplete graft was produced, where there was holes and strips in the graft.There was harm associated and a 10 minute extension in procedure.Due diligence is complete.No additional information is available.No additional consequences have been reported as a result of this malfunction.
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Manufacturer Narrative
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This event has been recorded by zimmer biomet under (b)(4).Evaluation and investigation is in process.Once the investigation is complete, a supplemental report will be filed.
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Manufacturer Narrative
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This event has been recorded by zimmer biomet under cmp (b)(4).This medwatch is being filed to relay additional information.The following sections were updated/corrected.Review of the most recent repair record could not be completed because the device was not returned for evaluation and repair.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.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 trends.
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Event Description
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Due diligence is complete and no additional information is available.
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Search Alerts/Recalls
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