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

Model Number	PEEK SWIVELOCK C,4.75X19.1MM
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/24/2026
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-2324pslc, suture anchor, peek-swivelock® c, 4.75 x 19.1 mm, vented, 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-2324pslc 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.13 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 did not seat.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: PEEK SWIVELOCK C,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: 24688606
• Report Number: 1220246-2026-01639
• Device Sequence Number: 15946718
• Product Code: MAI
• UDI-Device Identifier: 00888867026919
• UDI-Public: (01)00888867026919(11)250422(17)300331(10)15424181
• 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: PEEK SWIVELOCK C,4.75X19.1MM
• Device Catalogue Number: AR-2324PSLC
• Device Lot Number: 15424181
• 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: 04/22/2025
• 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