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 Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2025
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 08-dec-2025, a sales representative reported via email that an ar-1288qtt-100 tibial tunnel quadlink kit (10 mm) snapped while attempting to shorten the femoral fibertag tightrope.The graft may have bottomed out, but no excessive force was believed to have been applied.The rupture occurred at the splice where the four tightrope sutures converge, resulting in loss of suspensory fixation.The graft and broken tightrope portion were removed, and a btb tightrope was passed into the fibertag whipstitch to complete the procedure.The event prolonged surgery by approximately 10 minutes, requiring additional anesthesia.The issue was discovered during a procedure on (b)(6)2025.Additional information was received on 12/15/2025: this occurred during an acl reconstruction procedure on (b)(6) 2025.The case was completed using an ar-1588btb-ib tightrope ii btb.No adverse effects were reported.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint device was not received for evaluation.Based on the information provided, which may include the returned device (if available), pictures, videos, event descriptions, and any additional field data, arthrex concluded the most likely cause of the reported failure the most likely cause of the reported and observed damage is user error, specifically, the application of excessive force during suture tensioning.Improper techniques, such as pulling too forcefully or adjusting the suture against a sharp or rough edge, may result in suture breakage.Directions for use dfu-0147-eo revision 4.Tightrope devices.G.Precautions 1.Acl/pcl/btb/rt/abs/cl/cls/pf/pfc tightrope only: excessive force on the shortening suture strands and/or tensioning the shortening suture strands not in-line with the bone socket may break the strands and impair the ability to fully seat the implant.No additional force on the shortening suture strands is required when the graft/wedge construct reaches the desired position in the femoral socket, and the graft stability is verified by pulling distally on the graft.The complaint allegation was not confirmed.No evidence of that failure was received.

• 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: 23908221
• Report Number: 1220246-2025-05873
• Device Sequence Number: 13034850
• Product Code: GAT
• UDI-Device Identifier: 00888867473638
• UDI-Public: (01)00888867473638(11)250618(17)290228(10)15452953
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 04/13/2026

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: 15452953
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/29/2025
• Supplement Report FDA Received Date: 04/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/18/2025
• 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