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Model Number ACL TIGHTROPE WITH FIBERTAG, ABS |
Device Problem
Therapeutic or Diagnostic Output Failure (3023)
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Patient Problem
Insufficient Information (4580)
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Event Date 09/17/2021 |
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 sales representative via email that an ar-1588tnt fibertag abs tightrope failed to properly tension down ar-1588tb-3 abs button.This was discovered during an acl reconstruction, surgeon had to use a swivelock to complete case.Additional info requested.
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Search Alerts/Recalls
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