ARTHREX, INC. SELF BUNCHING KL 1.8 FIBERTAK, SHOULDER; FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE
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Model Number SELF BUNCHING KL 1.8 FIBERTAK, SHOULDER |
Device Problems
Break (1069); Physical Resistance/Sticking (4012)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 09/23/2022 |
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 (b)(6) 2022, it was reported by a distributor via sems that an ar-3636 1.8 knotless fibertak anchor seemed to be jammed after being inserted halfway and mallet down.The sutures were not able to shuttle so they were cut.At this point, it was noticed that the tip of the inserter had broken off and was stuck in the bone socket.Holes were drilled adjacent to the inserter tip to free it from the bone.Various graspers were used to remove the broken piece.This was discovered during a bankart procedure on (b)(6) 2022.Case was completed without further issues.
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