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Model Number ACL TIGHTROPE WITH FIBERTAG, ABS |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
Insufficient Information (4580)
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Event Date 03/05/2024 |
Event Type
malfunction
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Event Description
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On (b)(6) 2024, it was reported by a sales representative via email that for an ar-1588tnt acl-fibertag®-tightrope® abs-implant, the needle came off the suture during whipstitch.This was detected on (b)(6) 2024 during use in an acl reconstruction procedure.The procedure was completed successfully by using another fibertag abs implant.
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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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Search Alerts/Recalls
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