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Model Number KNOTLESS T-ROPE SYN-DESMOSIS 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 01/09/2024 |
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 1/15/2024, it was reported by an arthrex subsidiary employee via email that an ar-8926t knotless tightrope syndesmosis repair implant had an issue.During an open reduction and internal fixation of ankle fracture surgery on (b)(6) 2024, the round plate was found to loosen due to a broken suture.The procedure was completed using another new ar-8926t; no secondary procedure is needed.All broken sutures were retrieved from the patient.Additional information received on 1/31/2024: there was a ten-minute delay in the case without adverse effects on the patient.
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Search Alerts/Recalls
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