ARTHREX, INC. TIGHTROPE ® II RT WITH DEPLOYING SUTURE; FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE
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Model Number TIGHTROPE ® II RT WITH DEPLOYING SUTURE |
Device Problems
Tear, Rip or Hole in Device Packaging (2385); Detachment of Device or Device Component (2907)
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Patient Problems
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/09/2022 |
Event Type
malfunction
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Event Description
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It was reported that during an anterior cruciate ligament surgery the tightrope button was flipped.When retracting the acl graft using the white tightrope sutures, one tore off.There was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
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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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Manufacturer Narrative
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Complaint confirmed.Upon visual evaluation, it was noted no problems with the blue suture, suture tape is damaged and tore off.White/black suture was not returned.The cause remains undetermined.
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Search Alerts/Recalls
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