MAUDE Adverse Event Report: Arthrex, Inc. Dbl Loaded Knotless FTAK, Knee 1-Pack; NON-DEGRADABLE FIXATN FASTENER

Model Number	Dbl Loaded Knotless FTAK, Knee 1-Pack
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/10/2026
Type of Reportable Event	Malfunction

• Brand Name: Dbl Loaded Knotless FTAK, Knee 1-Pack
• Common Device Name: NON-DEGRADABLE FIXATN FASTENER
• 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: 50408217
• Report Number: 1220246-2026-04460
• Device Sequence Number: 13054726
• Product Code: MBI
• UDI-Device Identifier: 00888867428058
• UDI-Public: (01)00888867428058(11)260629(17)310531(10)15646273
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K251809
• 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): 08/24/2026

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: Dbl Loaded Knotless FTAK, Knee 1-Pack
• Device Catalogue Number: AR-3740SP-1
• Device Lot Number: 15646273
• 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: Not provided
• Initial Report FDA Received Date: 08/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/29/2026
• 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