ARTHREX, INC. BIO-COMP SWVLK SP, 4.75X24.5MM; FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE
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Model Number BIO-COMP SWVLK SP, 4.75X24.5MM |
Device Problems
Break (1069); Entrapment of Device (1212)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 05/04/2021 |
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 after the ar-2324bcm anchor was implanted, the surgeon passed the suture through the tendon and was tying a knot and the suture broke with very little tension.The anchor was removed, but the metal tip of the anchor is still in the patient.No injuries occurred and the surgery was completed successfully with a 6.5 corkscrew.
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