MAUDE Adverse Event Report: Arthrex, Inc. #2 TW BRAID POLYBLEND SUTR,38; POLYETHYLENE SYNTHETIC SUTURE

Model Number	#2 TW BRAID POLYBLEND SUTR,38
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2026
Type of Reportable Event	Malfunction

• Brand Name: #2 TW BRAID POLYBLEND SUTR,38
• 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: 50933372
• Report Number: 1220246-2026-04942
• Device Sequence Number: 10759784
• Product Code: GAT
• UDI-Device Identifier: 00888867041301
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 09/29/2026

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 TW BRAID POLYBLEND SUTR,38
• Device Catalogue Number: AR-7203
• Device Lot Number: 32840
• 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: 09/11/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/01/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown