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

Model Number	QUADLINK IMPLANT SYSTEM, 11MM
Medical Device Problem Codes	Break (1069); Material Twisted/Bent (2981)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2025
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 (b)(6) 2025, a sales representative reported via (b)(4) that an ar-1288qis-110 quadlink implant systems tip broke.This occurred during when the device broke in the joint.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.One unpackaged ar-1288qis-110 was received for investigation.Visual evaluation of the device noted that the tip was broken.Functional testing was not performed due to the damage to the device.The most likely cause for the reported failure can be attributed to user error due to applying excessive mechanical forces upon insertion and/or prying/leveraging the device during use.The complaint allegation is confirmed.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The front part of the drill bit broke because of wrong approach when drilled back.It was switched on when too close to the bone instead of approaching with high speed.This is misuse of the surgeon.
Additional Manufacturer Narrative
Additional information: b3, b5, g3, h6.
Event or Problem Description
Additional information was provided on 02/24/2025 indicating that the component c19790-01, part of the ar-1288qis-110, was the device that bent.The event occurred during an acl reconstruction on (b)(6) 2025 when the device tip bent.The patient was noted to have great bone quality.All fragments were retrieved from the patient, and a new device was used to complete the procedure.The delay was approximately two minutes and did not require additional anesthesia.

• 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: 21596225
• Report Number: 1220246-2025-00922
• Device Sequence Number: 15688163
• Product Code: MBI
• UDI-Device Identifier: 00888867344761
• UDI-Public: 00888867344761
• 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: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/01/2025

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
• Device Model Number: QUADLINK IMPLANT SYSTEM, 11MM
• Device Catalogue Number: AR-1288QIS-110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2025
• Supplement Date Received by Manufacturer: 08/28/2025; 10/08/2025; 02/24/2025
• Initial Report FDA Received Date: 03/13/2025
• Supplement Report FDA Received Date: 09/03/2025; 10/08/2025; 12/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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