Model Number ACL TIGHTROPE WITH FIBERTAG |
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 02/06/2024 |
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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It was reported that during an anterior cruciate ligament surgery the needle got detached from the suture.The tendon was completed with a free needle.There was no harm for patient, operator or third party.The surgery was finished successfully with the same device was used.It was not necessary to switch the surgical technique or do a second surgery.
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Search Alerts/Recalls
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