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	03/05/2026
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 05-mar-2026, a sales representative reported via email that an ar-1288qai-90 all-inside quadlink kit experienced a fibertag tightrope failure.The issue was identified during an acl reconstruction procedure on (b)(6) 2026.There was no reported patient harm, and the surgery was completed.Additional information was received on 11-mar-2026: the issue occurred inside the patient during graft tensioning into the femoral tunnel.As tension was applied, the suture frayed and ripped off the metal button, resulting in failure of the device.All detached fragments were accounted for and retrieved from the patient during the procedure.The case was completed using an ar-1588btb-ib tightrope ii btb.The incident caused a brief delay of approximately 5¿10 minutes, and no additional anesthesia was administered.

• 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: 24689429
• Report Number: 1220246-2026-01649
• Device Sequence Number: 10004689
• 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: CA
• 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: 03/05/2026
• Supplement Date Received by Manufacturer: 07/07/2026
• Initial Report FDA Received Date: 03/25/2026
• 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