MAUDE Adverse Event Report: ARTHREX, INC. QUADLINK IMPLANT SYSTEM, 10MM; NON-DEGRADABLE FIXATN FASTENER

Model Number	QUADLINK IMPLANT SYSTEM, 10MM
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 2/28/2025, a sales representative reported via phone that an ar-1288qis-100 quadlink implant system had an issue during a quadriceps acl reconstruction procedure on (b)(6) 2025.When the surgeon was cinching the sutures, one side prematurely tensioned down and did not allow the implant to tension appropriately.All sutures were cut and removed together with the implant from the patient.Nothing broke inside the patient, and there was no harm.The complaint device was discarded, and no pictures were taken.An ar-1588tnt acl-fibertag-tightrope abs-implant with an unknown lot number was used to complete the procedure successfully.There was a case delay of under 15 minutes, and no additional anesthesia was administered.This occurred during use with no reported patient harm.
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.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 use error due to mishandling.

• Brand Name: QUADLINK IMPLANT SYSTEM, 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: 21619555
• Report Number: 1220246-2025-00980
• Device Sequence Number: 6791222
• Product Code: MBI
• UDI-Device Identifier: 00888867344754
• UDI-Public: (01)00888867344754(11)231214(17)271130(10)15180816
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 09/17/2025

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: QUADLINK IMPLANT SYSTEM, 10MM
• Device Catalogue Number: AR-1288QIS-100
• Device Lot Number: 15180816
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2025
• Supplement Date Received by Manufacturer: 09/17/2025
• Initial Report FDA Received Date: 03/17/2025
• Supplement Report FDA Received Date: 09/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2023
• 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