ARTHREX, INC. TIGHTROPE ® II BTB WITH DEPLOYING SUTURE; FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE
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Model Number TIGHTROPE ® II BTB WITH DEPLOYING SUTURE |
Device Problem
Break (1069)
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Patient Problem
Insufficient Information (4580)
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Event Date 11/15/2022 |
Event Type
Injury
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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 sales representative via email that an ar-1588btb-2j tightrope ii btb free rail would not pull through with the wire and wire broke.Another one was used to complete the case.This was discovered while assembling the graft on the back table during a procedure on (b)(6) 2022.Additional information received on (b)(6) 2022: this was discovered on the back table, while prepping the graft, during a btb aclr procedure.Case was competed by switching to a two-incision approach and used an ar-4020c-08 screw instead of a tightrope.
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