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Model Number K-LESS T-ROPE W/DRV, SYN REPR, TI |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/07/2022 |
Event Type
malfunction
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Event Description
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On (b)(6) 2022, it was reported by a sales representative via email that a total of four ar-8925t syndesmosis tightrope broke at the round lateral button during the final tightening.Surgeon removed all failed hardware and had to make a medial incision in order to retrieve the buttons.This caused a significant delay in the procured.Case was completed using a syndesmosis screw.This was discovered during an ankle fracture procedure on (b)(6) 2022 additional information received on 4/8/2022: all four ar-8925t syndesmosis tightrope broke and all were removed from inside the patient.No additional anesthesia had to be administered to patient due to delay in procedure.
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Manufacturer Narrative
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The complaint is confirmed based on the customer-provided photo, which displays the three broken suture constructs.However, the cause remains undetermined without receipt of the devices for physical evaluation.No change in harm was identified.
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Search Alerts/Recalls
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