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Model Number DOUBLE LOADED KNOTLESS FIBERTAK, KNEE |
Device Problem
Material Split, Cut or Torn (4008)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/06/2024 |
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 02/12/2024, it was reported by a sales representative via phone that an ar-3740sp double loaded knotless knee fibertak® anchors black stitch was cut.This occurred during a biceps tenodesis on (b)(6) 2024 upon implanting, the black stitch was cut.The surgeon changed the technique and secured the tendon with the suture that was not damaged.There was no harm to the patient.
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Search Alerts/Recalls
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