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

Model Number	BIO-COMP SWVLK C, CLD 4.75X19.1MM
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 5th march 2026, it was reported by an arthrex employee via email that for an ar-2324bcc, suture anchor, biocomposite swivelock® c, 4.75 mm x 19.1 mm, closed eyelet, the anchor could not be set successfully.This was detected during a rotator cuff repair surgery on (b)(6) 2026.The procedure was completed successfully as another new ar-2324bcc was used.Ar-1927pb and ar-2324ptb were used to prepare the bone socket.The bone quality of patient was soft and no fragments were found.13th march 2026 - the complaint initiator replied that the anchor could not be fully implanted, so the surgeon needed to replace a new anchor to complete the procedure.He confirmed that the anchor was deployed successfully, but implant would not seat.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: BIO-COMP SWVLK C, CLD 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: 24688393
• Report Number: 1220246-2026-01636
• Device Sequence Number: 10041940
• Product Code: MAI
• UDI-Device Identifier: 00888867026827
• UDI-Public: (01)00888867026827(11)250526(17)290430(10)15441504
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K203495
• 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,Followup
• Report Date (Section B): 05/20/2026

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 SWVLK C, CLD 4.75X19.1MM
• Device Catalogue Number: AR-2324BCC
• Device Lot Number: 15441504
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2026
• Supplement Date Received by Manufacturer: 05/14/2026
• Initial Report FDA Received Date: 03/25/2026
• Supplement Report FDA Received Date: 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/26/2025
• 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