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
Break (1069)
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Patient Problem
Insufficient Information (4580)
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Event Date 02/18/2022 |
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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On 20-feb-2022, it was reported by a sales rep via email that an ar-1588rt-2j, tightrope ® ii rt with deploying suture was used during an acl reconstruction.The surgeon had successfully implant an 8.5mm x 7cm quadrupled semi-t and fixated the abs with a 14mm button.On the final tensioning of the femoral side, there was an audible pop.The surgeon dissected down laterally to find the ar-1588rt-2j had snapped.It was final tensioning in full extension but did not appear to be an excessive force.The remaining strands of suture tape were tied over an endo button and backed up with a swivelock.The surgeon was happy with tension/fixation etc.However has lost some confidence in tightrope 2.The remaining parts of the tightrope were double bagged in a biohazard bag.The product cannot be sterilized.
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