MAUDE Adverse Event Report: ARTHREX, INC. TIBIAL TUNNEL QUADLINK KIT, 10MM; NON-DEGRADABLE FIXATN FASTENER

Model Number	TIBIAL TUNNEL QUADLINK KIT, 10MM
Medical Device Problem Codes	Positioning Failure (1158); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On (b)(6) 2026, it was reported by a sales representative via email that an ar-1288qtt-100 tibial tunnel quadlink kit experienced an issue during use.This was discovered during an autograft acl reconstruction with quad tendon procedure on (b)(6) 2026.After the autograft quad tendon was shuttled, the 17 mm abs button was attached.While tensioning the tibial side, the fibertag tightrope ii failed, causing the graft to slip back into the joint and subsequently into the tibial tunnel.The graft was removed, the fibertag tightrope ii was cut out, and a new device was attached.The graft was then shuttled, implanted, and tensioned successfully on the second attempt using a new ar-1588rtt2 fibertag tightrope ii.No adverse patient effects were reported.Additional information was received on 06-mar-2026: this occurred in the patient and delayed the case by 10 minutes.No additional anesthesia was administered.

• Brand Name: TIBIAL TUNNEL QUADLINK KIT, 10MM
• 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: 24625729
• Report Number: 1220246-2026-01480
• Device Sequence Number: 9015176
• Product Code: GAT
• UDI-Device Identifier: 00888867473638
• UDI-Public: (01)00888867473638(11)250812(17)290430(10)15481256
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K241235
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2026

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: TIBIAL TUNNEL QUADLINK KIT, 10MM
• Device Catalogue Number: AR-1288QTT-100
• Device Lot Number: 15481256
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2026
• Supplement Date Received by Manufacturer: 07/07/2026
• Initial Report FDA Received Date: 03/18/2026
• Supplement Report FDA Received Date: 07/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/12/2025
• 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