MAUDE Adverse Event Report: Arthrex, Inc. 0 FW 38" WHITE; POLYETHYLENE SYNTHETIC SUTURE

Model Number	0 FW 38" WHITE
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2026
Type of Reportable Event	Malfunction

• Brand Name: 0 FW 38" WHITE
• 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: 50787988
• Report Number: 1220246-2026-04754
• Device Sequence Number: 21192961
• Product Code: GAT
• UDI-Device Identifier: 00888867041851
• UDI-Public: (01)00888867041851(11)240401(17)290331(10)30824
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 09/16/2026

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: 0 FW 38" WHITE
• Device Catalogue Number: AR-7255
• Device Lot Number: 30824
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown