MAUDE Adverse Event Report: ARTHREX, INC. QUADLINK IMPLANT SYSTEM, 9MM; NON-DEGRADABLE FIXATN FASTENER

Model Number	QUADLINK IMPLANT SYSTEM, 9MM
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, it was reported by a sales representative via email that the quad pro harvester from an ar-1288qis-90 quadlink implant system failed to completely amputate the quad tendon when fully pressed.A small piece of tendon remained intact and required manual removal by twisting the device.Additionally, upon unwinding the suture from the card, the surgeon noticed that one white tail had slid through the mechanism and come undone.To salvage the graft preparation that had already been done, the surgeon utilized an ar-1588tn-21 tightrope ii abs.After this, surgeon was able to complete case normally.This was discovered during an anterior cruciate ligament reconstruction procedure on (b)(6) 2025.
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 allegations are not confirmed based on the customer-provided picture.Visual evaluation of the customer provided photo noted no apparent issues with the device.Refer to attachments.Based on the information provided which may include pictures, videos, the event description, and any additional information from the field, arthrex was able to conclude a most likely cause for the reported failure of an ar-1288qis-90 quadlink implant system failing to completely amputate the quad tendon when fully pressed.The most likely cause for the reported failure can be attributed to user error.The quadpro¿ tendon harvester surgical technique, lt1-000052-en-us_d, notes the following under step 6: using controlled, quarter-turn rotations in the same direction or, alternatively, by rotating the harvester back and forth during the stripping process will allow for an easier advancement of the device compared to a pushing technique.Based on the information provided which may include pictures, videos, the event description, and any additional information from the field, arthrex was able to conclude a most likely cause for the reported failure of the white tail sliding through the mechanism and coming undone.The most likely cause for the reported failure can be attributed to user error likely due to pulling the suture in the incorrect direction.

• Brand Name: QUADLINK IMPLANT SYSTEM, 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: 21546387
• Report Number: 1220246-2025-00841
• Device Sequence Number: 8050603
• Product Code: MBI
• UDI-Device Identifier: 00888867344747
• UDI-Public: (01)00888867344747(11)241119(17)280831(10)15350084
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 09/11/2025

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, 9MM
• Device Catalogue Number: AR-1288QIS-90
• Device Lot Number: 15350084
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2025
• Supplement Date Received by Manufacturer: 09/04/2025
• Initial Report FDA Received Date: 03/07/2025
• Supplement Report FDA Received Date: 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/19/2024
• 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