It was reported during a revision acl procedure, upon inserting the femoral ar-4020c-07 fastthread biocomposite interference screw (lot: 10248522) the screw crumbled into multiple pieces after one and a half turns.The rep confirmed all broken pieces of the screw were retrieved by using a grasper.A second ar-4020c-07 from a different lot (lot: 10262903) was brought in.Upon inserting, the screw broke into two halves after one and a half turns.The rep confirmed all pieces were fully removed by using a grasper.Another manufacturer's screw was brought in and used to complete the procedure without further issue.Only one screw is available to return (lot: 10262903) as the other screw was discarded.The rep stated the revision took place due the patient re-tearing their acl.The original implanted arthrex tightrope and fiberwire were explanted during the revision.Additional information received on 08/01/2019: the rep confirmed the revision was due to re-injury and was not implant related.The primary procedure was a quad tendon autograft, soft tissue.The primary and revision procedure were performed by the same surgeon and took place at the same facility.The surgeon revised with a btb autograft with interference screw fixation.During the revision procedure the femoral interference screw fractured at the tip during the first turn.This issue occurred twice.The surgeon tapped and notched and had a great angle.The following arthrex parts were implanted during the primary procedure, and explanted during the revision: ar-1588rt // lot: 10211964 // qty.:1.Ar-1588tb-3 // lot: 10223250 // qty.:1.Ar-1588tn // lot: 10216139 // qty.:1.
|