MAUDE Adverse Event Report: Arthrex, Inc. SwiveLock, SP BC 5.5MM; NON-DEGRADABLE FIXATN FASTENER

Model Number	SwiveLock, SP BC 5.5MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 31st august 2026, it was reported by an arthrex employee via email that for an: 1.(ar-2324bcsp, 4.75 mm biocomposite swivelock® anchor, self punching with white/blue 1.3 mm suturetape lot:15441583 ) the peek tip broke during insertion.The bone quality was normal.2.(ar-2323bcsp, 5.5 mm biocomposite swivelock® anchor, self punching with white/blue 1.3 mm suture tape, ve5 lot:15399119) an attempt was made to insert the anchor using the self-punching technique, but insertion was unsuccessful.Upon removing the anchor, it was discovered that the peek tip was missing.As the tip was caught on the tape that had been passed through the rotator cuff, it had to be retrieved.Inspection of the device revealed that the tape securing the peek tip had snapped.This was detected during use in an unknown procedure on (b)(6) 2026.The procedure was completed successfully by using a product with the same part number.No significant surgery delay reported.All of the product/fragment was removed and nothing remains in the patient.No additional anesthesia administered to the patient.No information about an instrument used to prepare/tap the bone socket for insertion of the implant.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: SwiveLock, SP BC 5.5MM
• Common Device Name: NON-DEGRADABLE FIXATN FASTENER
• Manufacturer (Section D): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer (Section G): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer Contact: jared engle ; +1(800)933-7001
• MDR Report Key: 50732449
• Report Number: 1220246-2026-04680
• Device Sequence Number: 10633524
• Product Code: MAI
• UDI-Device Identifier: 00888867384439
• UDI-Public: (01)00888867384439(11)250304(17)290228(10)15399119
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K222263
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 09/11/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SwiveLock, SP BC 5.5MM
• Device Catalogue Number: AR-2323BCSP
• Device Lot Number: 15399119
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 09/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/04/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown