MAUDE Adverse Event Report: ARTHREX, INC. ALL-INSIDE QUADLINK KIT, 9MM; NON-DEGRADABLE FIXATN FASTENER

Model Number	ALL-INSIDE QUADLINK KIT, 9MM
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2026
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, a sales representative reported via email that an ar-1288qai-90 all-inside quadlink kit, 9 mm, experienced an issue during an arthroscopic-aided acl reconstruction procedure.At the final stage of all-inside quad acl reconstruction, the suture on the femoral tightrope snapped, rendering the implant nonfunctional.The graft had been shuttled into the joint, the femoral button was flipped on the cortex, and the tightrope was provisionally tensioned to draw the graft into the femoral socket.Once approximately 10 mm of graft was within the femoral socket, the tibial side was provisionally tensioned until approximately 15 mm of graft was seated within the tibial tunnel.At that point, the surgeon removed the scope and returned to the femoral tightrope to complete final tensioning.While pulling the white sutures individually, the tightrope snapped.All fragments were retrieved.The case was completed by removing the graft from the joint and applying new ar-1588rtt2-ib fibertag tightrope ii implants to the graft.The graft was then reinserted, and the procedure was completed.A case delay of approximately thirty minutes, with additional anesthesia administered, occurred due to fragment removal and graft re-preparation.No patient harm was reported.

• Brand Name: ALL-INSIDE QUADLINK KIT, 9MM
• 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: 24650853
• Report Number: 1220246-2026-01571
• Device Sequence Number: 18591073
• Product Code: GAT
• UDI-Device Identifier: 00888867473584
• UDI-Public: (01)00888867473584(11)251117(17)291031(10)15531189
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 07/09/2026

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: ALL-INSIDE QUADLINK KIT, 9MM
• Device Catalogue Number: AR-1288QAI-90
• Device Lot Number: 15531189
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2026
• Supplement Date Received by Manufacturer: 07/06/2026
• Initial Report FDA Received Date: 03/20/2026
• Supplement Report FDA Received Date: 07/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/17/2025
• 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