MAUDE Adverse Event Report: ARTHREX, INC. SUTURELASSO SD WIRE LOOP; ORTHOPEDIC MANUAL SURG INSTR

Model Number	SUTURELASSO SD WIRE LOOP
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 25-dec-2025, it was reported by an arthrex subsidiary employee via (b)(4) that 2 ar-4068-05sd suture lassos sutures became frayed and unusable when tightening.This occurred during use in a case with no patient effect.No delay in case.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: SUTURELASSO SD WIRE LOOP
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• 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: 24037546
• Report Number: 1220246-2026-00158
• Device Sequence Number: 13014294
• Product Code: LXH
• UDI-Device Identifier: 00888867031418
• UDI-Public: (01)00888867031418(11)241201(17)291130(10)4304154116
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 05/05/2026

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: SUTURELASSO SD WIRE LOOP
• Device Catalogue Number: AR-4068-05SD
• Device Lot Number: 4304154116
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/25/2025
• 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): No
• Date Device Manufactured: 12/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown