Model Number N/A |
Device Problems
Failure to Cut (2587); Output Problem (3005)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/15/2020 |
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 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 during surgery the dermatome is taking a thicker graft than what is indicated on the setting lever.There was no harm or delay that occurred during the event and there was no impact or damage to the graph.No adverse event was 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 that the unit was out of calibration and the motor had a low rpm.The motor was replaced and the unit was recalibrated, and resolved the reported issue.Review of the previous repair record identified unrelated repairs to the reported event.The device was tested and found to be functioning to specifications prior to release to the customer.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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There is no additional information.
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Search Alerts/Recalls
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