It was reported, patient underwent an arthroscopic labral repair on (b)(6) 2014.During the procedure, a juggerknot anchor pulled out.A second juggerknot anchor was inserted but the suture fractured while tying the knot.Competitor product was utilized to complete the procedure.
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Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly.There are warnings in the package insert that state that this type of event can occur: under warnings, number 2 states, "improper selection, placement, positioning, and fixation of the device can lead to failure of the device or the procedure.".
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