MAUDE Adverse Event Report: ARTHREX, INC. SUTR ANCH,PEEK CRKSCRW FT,TRI-PLAY; NON-DEGRADABLE FIXATN FASTENER

Model Number	SUTR ANCH,PEEK CRKSCRW FT,TRI-PLAY
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On (b)(6) 2026, an arthrex employee reported via email that the ar-1927psf-3 sutr anch, peek corkscrew ft, tri-play (batch 15408230) experienced a fiberwire breakage upon tensioning while the surgeon was anchoring down the lateral row in a rotator cuff case.The issue occurred during a rotator cuff repair procedure on (b)(6) 2026.No fragments broke off inside the patient.The surgeon continued with the procedure, although the sutures were not tensioned to the desired level.

• Brand Name: SUTR ANCH,PEEK CRKSCRW FT,TRI-PLAY
• Common Device Name: NON-DEGRADABLE FIXATN FASTENER
• 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: 24334299
• Report Number: 1220246-2026-00578
• Device Sequence Number: 9791488
• Product Code: MBI
• UDI-Device Identifier: 00888867023642
• UDI-Public: (01)00888867023642(11)250324(17)300228(10)15408230
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K143745
• 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): 05/27/2026

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: SUTR ANCH,PEEK CRKSCRW FT,TRI-PLAY
• Device Catalogue Number: AR-1927PSF-3
• Device Lot Number: 15408230
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2026
• Supplement Date Received by Manufacturer: 05/26/2026
• Initial Report FDA Received Date: 02/13/2026
• Supplement Report FDA Received Date: 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2025
• 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