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	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2026
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 12-mar-2026, a facility representative reported via phone that an ar-1288qai-90 final tensioning, the quad tight rope broke during final tension.Graft had to be removed and replaced, no patient harm.Approximately 20¿30-minute delay.

• 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: 24755759
• Report Number: 1220246-2026-01781
• Device Sequence Number: 18328873
• Product Code: GAT
• UDI-Device Identifier: 00888867473584
• UDI-Public: (01)00888867473584(11)250916(17)290531(10)15498671
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K241235
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• 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: 15498671
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2026
• Supplement Date Received by Manufacturer: 07/07/2026
• Initial Report FDA Received Date: 04/01/2026
• Supplement Report FDA Received Date: 07/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/16/2025
• 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