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 Date 08/04/2020 |
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 an evaluation of this device is completed, a follow-up/final report will be submitted.(b)(6).
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Event Description
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It was reported that this device was tearing skin during surgery.There was no delay nor any harm/injury.No adverse events were 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).This medwatch is being filed to relay additional information.Review of the most recent repair record determined the unit was out of calibration and control bar not flush.The control bar was replaced and device calibrated and resolved the reported issue.Device is used for treatment.A definitive root cause cannot be determined.The event is confirmed.
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Event Description
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No additional event information available.
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Search Alerts/Recalls
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