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

Model Number	QUADLINK IMPLANT SYSTEM, 10MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2024
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 09/12/2024, it was reported by a sales representative via (b)(4) that an ar-1288qis-100 quadlink implant system broke.This occurred during an acl primary reconstruction when the flipcutter iii in the 10mm quadlink implant system broke while reaming the tibial tunnel.The outer shaft that attaches to the flipcutter iii dial housing broke loose from the plastic resulting in the inner mechanical mechanism breaking as well.At that point, they had to use the graspers to force the flip cutter blade to close so that they could remove it from the joint.This added substantial time to the case.
Event or Problem Description
On 09/17/2024 additional information was received by a sales representative via email who stated that another flipcutter iii was used to complete the procedure.All fragments were retrieved from the patient.No photos were taken.The device was discarded into a sharps bin.
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 improper bone prep; misaligned insertion; prying/leveraging the device during insertion.

• 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: 20301032
• Report Number: 1220246-2024-07838
• Device Sequence Number: 8686247
• Product Code: MBI
• UDI-Device Identifier: 00888867344754
• UDI-Public: (01)00888867344754(11)230206(17)261130(10)15053105
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 06/16/2025

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: 15053105
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2024
• Supplement Date Received by Manufacturer: 09/17/2024; 06/09/2025
• Initial Report FDA Received Date: 09/25/2024
• Supplement Report FDA Received Date: 12/19/2024; 06/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/06/2023
• 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