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 Problem
Material Split, Cut or Torn (4008)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 11/23/2022 |
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 (acl) surgery the tightrope tore off above the button during retraction without exerting much force.Parts have to remain in the patient.There was no harm for patient, operator or third party.The surgery was finished successfully with a different device, ar-4030p-09.It was not necessary to switch the surgical technique or do a second surgery.
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