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Model Number ACL TIGHTROPE WITH FIBERTAG, ABS |
Device Problem
Defective Component (2292)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/10/2024 |
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) 2024, it was reported by a sales representative via email that an ar-1588tnt acl tightrope mechanism did not cinch down.No patient was affected negatively and the case was able to be completed; we tied the sutures over an abs button and put them down into a swivelock with internalbrace.This occurred during use in a case with no patient effect.Additional information requested.
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Search Alerts/Recalls
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