MAUDE Adverse Event Report: ARTHREX, INC. QUADLINK IMPLANT SYSTEM, 9MM; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	QUADLINK IMPLANT SYSTEM, 9MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 10/03/2025, a sales representative reported via email that an ar-1288qis-90 quadlink implant system experienced an issue during an acl reconstruction procedure using a quadriceps tendon autograft on (b)(6) 2025.The femoral tightrope broke while tensioning the graft into the femoral tunnel.The surgeon pulled the graft back out through the portal, and the tibial tightrope detached from the fibertag construct.All sutures were removed from the graft and re-prepped with a new fibertag and fibertag abs tightrope.No harm was done to the patient.Additional information was received on 10/13/2025: an ar-1588rtt acl fibertag tightrope implant and ar-1588tnt acl-fibertag tightrope were used to complete the case.The surgery was delayed by about 20 minutes.No additional anesthesia was administered to the patient.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Complaint allegation is not confirmed.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 of the reported failure can be attributed to user error of the device due to either excessive force used during suture passing or the device coming in contact with another device during use.

• Brand Name: QUADLINK IMPLANT SYSTEM, 9MM
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• 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: 23292327
• Report Number: 1220246-2025-04579
• Device Sequence Number: 9935685
• Product Code: MBI
• UDI-Device Identifier: 00888867344747
• UDI-Public: (01)00888867344747(11)250715(17)270731(10)15467279
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 02/02/2026

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: QUADLINK IMPLANT SYSTEM, 9MM
• Device Catalogue Number: AR-1288QIS-90
• Device Lot Number: 15467279
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/03/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2025
• Supplement Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/15/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown