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

Model Number	ALL-INSIDE QUADLINK KIT, 10MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6), a sales representative reported via email that the tightrope construct on the femoral side from ar-1288qai-100 all-inside quadlink kit broke during the procedure.The case was continued using a replacement ar-1588rtt2-ib fibertag tightrope ii implant, which also broke.A second ar-1588rtt2-ib fibertag tightrope ii implant from the same lot was then opened and functioned without issue.The event occurred intraoperatively on (b)(6), with no reported patient harm.Additional information was received on (b)(6): it was reported that an ar-1588rtt2-ib fibertag tightrope ii implant device broke while pulling the tightrope through the femoral tunnel and tensioning it down during an acl reconstruction procedure.The break occurred inside the patient.Both implants that broke were removed, and another tightrope was implanted on the femoral side.The femoral side had to be redone twice, resulting in an approximate 15-minute surgical delay.No additional anesthesia information was reported, other than the delay time.No adverse patient effects were reported during or following the procedure due to this issue.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided ¿ which may include the returned device (if available), photographs, videos, event description, and any additional field input ¿ arthrex has determined the most likely cause.The most likely cause is user-related, such as increased friction, tunnel-edge abrasion, or excessive forces during tensioning.

• Brand Name: ALL-INSIDE 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: 24578951
• Report Number: 1220246-2026-01361
• Device Sequence Number: 10474819
• Product Code: GAT
• UDI-Device Identifier: 00888867473553
• UDI-Public: (01)00888867473553(11)251201(17)291031(10)15537681
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 04/06/2026

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, 10MM
• Device Catalogue Number: AR-1288QAI-100
• Device Lot Number: 15537681
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/19/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2026
• Supplement Date Received by Manufacturer: 04/03/2026
• Initial Report FDA Received Date: 03/12/2026
• Supplement Report FDA Received Date: 04/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/01/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown