ARTHREX, INC. H/W INTERNALBRACE LGMNT AUGMNT REPR KIT; FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE
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Model Number H/W INTERNALBRACE LGMNT AUGMNT REPR KIT |
Device Problem
Break (1069)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 12/23/2021 |
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) 2021, it was reported by a sales representative via email that an ar-8990st-2 dx fibertak was inserted through a 1.6mm prepared bone tunnel and after it passed through the cortex, it was discovered that the forks on the inserter device had shredded the sutures bundle.This was discovered during a revision of a failed cmc internal brace on (b)(6) 22021.Surgeon redirected tunnels and used a single-loaded fibertak dx to complete procedure.Additional information received 12/23/2021.There were not arthrex devices explanted.
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Search Alerts/Recalls
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