Model Number N/A |
Device Problems
Failure to Cut (2587); Output Problem (3005)
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Patient Problem
Abrasion (1689)
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Event Date 11/02/2020 |
Event Type
Injury
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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 when taking a split skin graft a full thickness was taken despite being set on the correct setting.The event occurred during surgery, there was a 1-15 minute delay.An alternate device was available for use.The graph was damaged and an additional graph taken.There were no additional consequences 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).Review of the most recent repair record determined the unit was out of calibration and bearings were replaced and resolved the reported issue.Device is used for treatment.Review of complaint history identified additional similar complaints for the reported item and part and lot combination.Complaints are monitored through monthly complaint review in order to identify potential adverse trends.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.The event cannot be confirmed.
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Event Description
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No additional event information.
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Search Alerts/Recalls
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