Model Number BTB TIGHTROPE W/ DEPLOYING SUTURE |
Device Problem
Physical Resistance/Sticking (4012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/07/2023 |
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 7/11/2023, it was reported by an arthrex employee via email that there was strong resistance when pulling the wire snare from an ar-1588btb-j btb tightrope.The case was completed using a new product.This was discovered on the back table while prepping the graft during a procedure on (b)(6) 2023.Additional information requested.Additional information provided 7/11/2023: the procedure performed was an acl repair.The case was completed by using a new ar-1588btb-j.
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Search Alerts/Recalls
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