MAUDE Adverse Event Report: ARTHREX, INC. ALL-INSIDE QUADLINK KIT, 10MM; POLYETHYLENE SYNTHETIC SUTURE

Model Number	ALL-INSIDE QUADLINK KIT, 10MM
Medical Device Problem Codes	Break (1069); Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 06/03/2025, a sales representative reported via email that the fibertag tightrope ii with internalbrace, included in an ar-1288qai-100 all-inside quadlink kit, did not properly tension the graft into the femoral tunnel.The issue was identified during an aclr procedure on (b)(6) 2025.The case was completed successfully, and no patient harm was reported.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: b5, g3, h3, h6.Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
Additional information received on 6/20/2025: during the procedure on (b)(6) 2025, the sutures broke but were successfully removed from the patient.The case was completed using an ar-1588rtt2-ib fibertag tightrope ii implant for the internalbrace to secure the graft.The case experienced a 30-minute delay, and additional anesthesia was administered to account for the extended time.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Complaint allegation is confirmed by the attached picture, which shows the suture frayed/damaged.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to user error of the device due to excessive force used during suture passing/tightening /tensioning.

• Brand Name: ALL-INSIDE QUADLINK KIT, 10MM
• Common Device Name: POLYETHYLENE SYNTHETIC SUTURE
• 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: 22317743
• Report Number: 1220246-2025-02640
• Device Sequence Number: 21037431
• Product Code: GAT
• UDI-Device Identifier: 00888867473553
• UDI-Public: (01)00888867473553(11)250225(17)281031(10)15394928
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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,Followup
• Report Date (Section B): 09/29/2025

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: 15394928
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2025
• Supplement Date Received by Manufacturer: 06/20/2025; 09/26/2025
• Initial Report FDA Received Date: 06/24/2025
• Supplement Report FDA Received Date: 07/14/2025; 09/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/25/2025
• 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