MAUDE Adverse Event Report: Arthrex, Inc. 2-0 FW LOOP 48" W/ØMOND NDL 26MM; POLYETHYLENE SYNTHETIC SUTURE

Model Number	2-0 FW LOOP 48" W/ØMOND NDL 26MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/31/2026
Type of Reportable Event	Malfunction

• Brand Name: 2-0 FW LOOP 48" W/ØMOND NDL 26MM
• Common Device Name: POLYETHYLENE SYNTHETIC SUTURE
• Manufacturer (Section D): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer (Section G): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer Contact: jared engle ; +1(800)933-7001
• MDR Report Key: 50277186
• Report Number: 1220246-2026-04351
• Device Sequence Number: 13344505
• Product Code: GAT
• UDI-Device Identifier: 00888867041646
• UDI-Public: (01)00888867041646(11)231001(17)280930(10)29775
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K122374
• 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
• Report Date (Section B): 08/17/2026

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: 2-0 FW LOOP 48" W/ØMOND NDL 26MM
• Device Catalogue Number: AR-7232-02
• Device Lot Number: 29775
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2026
• Initial Report FDA Received Date: 08/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2023
• 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