MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMP, SWIVELOCK C, TT, 4.75X19.1MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number	BIO-COMP, SWIVELOCK C, TT, 4.75X19.1MM
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 29th december 2025, it was reported by a distributor via email that for an ar-2324bcctt, suture anchor, biocomposite swivelock® c vented 4.75 x 19.1 mm, with tigertape® loop suture (white/black), the swivelock screw was deformed during insertion into distal humerus.This was detected during use in a lucl repair procedure on (b)(6) 2025.The procedure was completed successfully as an additional swivelock was used.Ar-1678-01, ar-1678-02, ar-2324ptb were used for hole preparation.Bone density test was not performed.No fragment was left inside the patient.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: BIO-COMP, SWIVELOCK C, TT, 4.75X19.1MM
• Common Device Name: BIO SOFT TISSUE FIXATN FASTNR
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 24041055
• Report Number: 1220246-2026-00172
• Device Sequence Number: 13382437
• Product Code: MAI
• UDI-Device Identifier: 00888867026858
• UDI-Public: (01)00888867026858(11)250616(17)290531(10)15452220
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K101823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2026

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: BIO-COMP, SWIVELOCK C, TT, 4.75X19.1MM
• Device Catalogue Number: AR-2324BCCTT
• Device Lot Number: 15452220
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2025
• Supplement Date Received by Manufacturer: 05/04/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2025
• 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