Model Number N/A |
Device Problem
Failure to Cut (2587)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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This event has been recorded by zimmer biomet under cmp-(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 the device was leaving holes in the graft when cutting.There was no harm or delay.No further information provided.No adverse event was reported as a result of this malfunction.
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Event Description
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There is no additional information.
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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 control bar was not flush with the master blade and the unit was out of calibration.The control bar was repositioned and device recalibrated which resolved the reported issue.Device is used for treatment.A definitive root cause cannot be determined.The event is confirmed.
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Search Alerts/Recalls
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