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Model Number N/A |
Device Problems
Failure to Cut (2587); Patient Device Interaction Problem (4001)
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Patient Problem
Localized Skin Lesion (4542)
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Event Date 03/22/2021 |
Event Type
Injury
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Manufacturer Narrative
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This event has been recorded by zimmer biomet under (b)(4).(b)(6).Once the investigation is complete, 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 was taking uneven skin graft.A 3 inch blade was used.There was no delay in procedure as there was an alternate device available for immediate use.An additional skin graft was required from the patient.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).This medwatch is being filed to relay additional information.The following sections were updated/corrected: b4, b5, d8, d9, g3, g6, h2, h10.Once the investigation is complete, a follow up/final report will be submitted.
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Event Description
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No additional event information available.
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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.The following sections were updated/corrected: b4, b5, d4, g3, g6, h2, h3, h4, h6, h8, h10.Review of the most recent repair record determined the 3 inch width plate was defective.The 3 inch width plate was replaced 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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There is no additional information.
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Search Alerts/Recalls
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