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	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 21 january 2025, it was reported by a sales representative via email that an ar-3740sp-1, dbl loaded knotless ftak knee 1-pack was reported to have failed during use.This occurred on 21 january 2025 during a lateral extra-articular tenodesis.It was reported that whilst undertaking lateral extra-articular tenodesis procedure, the surgeon used ar-3710 to drill a hole for ar-3740sp-1 anchor which was implanted.After the iliotibial band was passed through the knotless loops of the anchor, the first black coloured suture limb was tensioned however during tensioning the limb which was being pulled snapped off in the surgeon's hand.Meaning that the first anchor loop could not be fully cinched.The case was completed successfully using only 1 of the 2 knotless loops to tie down the iliotibial band.There was case involvement.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• 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 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 24303101
• Report Number: 1220246-2026-00489
• Device Sequence Number: 5142763
• Product Code: MBI
• UDI-Device Identifier: 00888867428058
• UDI-Public: 00888867428058
• 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,Followup
• Report Date (Section B): 05/28/2026

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: 15335420
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2026
• Supplement Date Received by Manufacturer: 05/28/2026
• Initial Report FDA Received Date: 02/10/2026
• Supplement Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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