ARTHREX, INC. FIBERTAK DX SUTURE ANCHOR WITH 1.33MM SUTURE TAPE; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
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Model Number AR-8990ST |
Device Problems
Break (1069); Entrapment of Device (1212); Activation, Positioning or Separation Problem (2906)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 06/24/2021 |
Event Type
malfunction
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Event Description
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Suture anchor failed to properly deploy correctly resulting in a piece of the tip of the shaft of the inserter to become imbedded in bone.This anchor was never implanted into the patient, the tip was not removed.Fda safety report id# (b)(4).
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