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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
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/08/2024 |
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.Investigation is in process.A follow-up report will be provided upon availability of additional information.
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Event Description
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On 02/09/2024, it was reported by a sales representative via email that an ar-1588tnt acl titghtrope came apart.This occurred during a case with no patient harm.Additional information requested additional information provided 2/20/24: there was a delay, as we had to re-suture the graft.I don¿t have the exact time but probably be an extra 15-20 min delay.We used another ar-1588tnt to complete the case.
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Search Alerts/Recalls
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