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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2025
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 10/02/2025, a sales representative reported via (b)(4) that the flipcutter iii component from the ar-1288qis-100 quadlink implant system experienced breakage while reaming the tibial tunnel.The inner rod of the flipcutter separated from the outer sheath.The inner sheath was removed without incident by closing the flipcutter with a locking grasper.The case was completed successfully, and no further details were provided.This was discovered during an acl reconstruction procedure on (b)(6) 2025, with no reported patient harm.Additional information has been requested on 10/06/2025.Additional information was received on 10/7/2025: during the procedure, the internal sleeve containing the flipcutter blade detached from the external sleeve.However, the internal sleeve with the blade was successfully removed without incident.The product involved was ar-1204ff flipcutter iii.The case was not significantly delayed, as the flipcutter blade was closed using a grasper and retracted through the acl tunnel within moments.No additional anesthesia was administered, and no adverse effects have been reported to date.No fragments were retained inside the patient.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Complaint allegation is confirmed by the attached picture, which shows that the outer tube was broken off.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 is user error resulting from excessive force during use, prying/ levering the device, and/or the device coming into contact with another device during use.

• 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: 23292650
• Report Number: 1220246-2025-04585
• Device Sequence Number: 9926544
• Product Code: MBI
• UDI-Device Identifier: 00888867344754
• UDI-Public: (01)00888867344754(11)250513(17)280531(10)15435237
• 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
• Report Date (Section B): 02/17/2026

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, 10MM
• Device Catalogue Number: AR-1288QIS-100
• Device Lot Number: 15435237
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2025
• Supplement Date Received by Manufacturer: 02/16/2026
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 02/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2025
• 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