ARTHREX, INC. DISSECTOR, CURVED 4.0MM X 13CM; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
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Model Number DISSECTOR, CURVED 4.0MM X 13CM |
Device Problem
Material Fragmentation (1261)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 12/01/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
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Event Description
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It was reported on (b)(6) 2022 by a sales representative via sems that an ar-8400cds dissector caused metal shavings when used.Case involvement, device broke during use, fragments unable to be removed.
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Manufacturer Narrative
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The complaint device was not received for evaluation.Based off the information provided, the most likely cause for the reported failure can be attributed to user error of the device due to prying/leveraging the attachment during use.
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Search Alerts/Recalls
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