On (b)(6) 2024, it was reported by a sales representative via email that an ar-2324kbcsp swivelock sp anchor could not be implanted.The surgeons attempted to self-punch the anchor, but the patient's bone quality was too hard.After multiple attempts with different angles, a green punch was used to create a pilot hole, but the anchor still wouldn't go in.The tuberosity ended up fracturing.Another ar-2324kbcsp swivelock sp was opened but ended up breaking into pieces during insertion.After debridement, the case was completed using two biocomposite knotless swivelock.This was discovered during a rotator cuff repair procedure on (b)(6) 2024.
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