ARTHREX, INC. DISSECTOR, SJ 3.0MM X 7CM; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
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Model Number DISSECTOR, SJ 3.0MM X 7CM |
Device Problems
Material Fragmentation (1261); Output Problem (3005)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 09/12/2022 |
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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On 9/20/2022, it was reported by a sales representative via phone that an ar-7300ds dissector had an issue.During an ankle arthroscopy procedure on (b)(6) 2022, when the surgeon was using the complaint device, the shaver was producing metal shards/debris inside the patient.The surgeon was not able to remove those metal pieces, he deemed it safe to leave them inside the patient.He used another ar-7300ds dissector, a different unknown lot number, to complete the procedure successfully with no impact to the patient.The patient is fine to date, the device was discarded.The sales representative stated that they had this issue occurring previously and the facility now wanted to report the complaint.
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Search Alerts/Recalls
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