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	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, a sales representative reported via email that an ar-1288qai-100 all-inside quadlink kit (10 mm) failed to tension properly.The tightrope mechanism appeared to ¿give out¿ while attempting to seat the graft in the femoral tunnel and could not suspend the graft using the tensioning tails.The autograft was then removed, and the defective tightrope was cut out and replaced with an ar-1588btb-ib tightrope ii btb, which functioned as intended.The case was delayed, and additional anesthesia was likely administered.No adverse patient effects were reported.This issue occurred during an acl reconstruction procedure on (b)(6) 2025, with no reported patient harm.Additional information was received on 29-dec-2025: the procedure was delayed by approximately 30 minutes, and the amount of additional anesthesia administered is unknown.The issue with the tightrope implant was first identified when the button was confirmed to be flipped, and the graft was being tensioned on the femoral side.At that point, the implant failed.There was no fraying of the tensioning tails during the event.The constant unloading occurred suddenly.No fragments remained inside the patient; all components were recovered intact.The flip cutter from the associated kit was used to prepare the socket for implant insertion.The bone quality was assessed as normal.
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.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 failure is a use error, including improper surgical technique associated with the device.The complaint allegation was not confirmed.No evidence of that failure was received.

• 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: 24036176
• Report Number: 1220246-2026-00136
• Device Sequence Number: 13076453
• Product Code: GAT
• UDI-Device Identifier: 00888867473553
• UDI-Public: (01)00888867473553(11)250729(17)290430(10)15473748
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K241235
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2026

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: 15473748
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2025
• Supplement Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/29/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown