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Model Number ACL TIGHTROPE WITH FIBERTAG, ABS |
Device Problems
Break (1069); Output Problem (3005)
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Patient Problem
Insufficient Information (4580)
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Event Date 01/31/2023 |
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) 2023, it was reported by a sales representative via sems that a ar-1588tnt acl-fibertag®-tightropes needle popped off after the first pass through the tendon.This occurred during a quad acl making prep difficult with a free needle.No additional information provided.Additional information requested.
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Search Alerts/Recalls
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