On 6/17/2022, it was reported by a sales representative via email that an ar-3638 knotless fibertak was implanted using the appropriate reusable curved drill guide and drill.Upon lightly setting the anchor, it was apparent that the white and black traction stitch, used to complete the knotless splice, had been displaced and was visible outside of the bone socket created.The surgeon chose to continue with a capsular plication using the repair stitch.When completing the splice, the knotless splice was not able to be tightened down all the way and became loose.At this point, the anchor was no longer effective at reducing tissue.The fibertak anchor came out in pieces and was not recoverable.Surgeon then over drilled the prepared bone socket, and inserted a ar-1938bc bio-composite suturetak to complete the case.This was discovered during an mdi instability procedure.
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