MAUDE Adverse Event Report: ARTHREX, INC. QUADLINK IMPLANT SYSTEM, 11MM; NON-DEGRADABLE FIXATN FASTENER

Model Number	QUADLINK IMPLANT SYSTEM, 11MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/17/2025
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 11/13/2025, an fda medwatch notification was received via email.A facility representative reported that the tip of an ar-1204ff flipcutter iii drill and an ar-1204ff flipcutter iii drill from the ar-1288qis-110 quadlink implant system broke off inside the patient's knee.The broken pieces were retrieved.This occurred during an acl (anterior cruciate ligament) reconstruction procedure on (b)(6) 2025.Additional information was received on 11/19/2025: both issues occurred during the removal of the devices from the bone, and all detached fragments were retrieved.The case was delayed by approximately one to two minutes while another product was opened.No additional anesthesia was administered, and no specific details regarding bone preparation or bone quality were documented.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided ¿ which may include the returned device (if available), photographs, videos, event description, and any additional field input ¿ arthrex has determined the most likely cause.The most likely cause is attributed to user-related factors such as off-axis insertion, improper bone preparation, or prying and leveraging the device with excessive force.

• Brand Name: QUADLINK IMPLANT SYSTEM, 11MM
• 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: 23705335
• Report Number: 1220246-2025-05349
• Device Sequence Number: 13422132
• Product Code: MBI
• UDI-Device Identifier: 00888867344761
• UDI-Public: (01)00888867344761(11)241123(17)280831(10)15352538
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K241235
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2026

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, 11MM
• Device Catalogue Number: AR-1288QIS-110
• Device Lot Number: 15352538
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2025
• Supplement Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/23/2024
• 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