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	Insufficient Information (4580)
Date of Event	12/16/2024
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 (b)(6)2024, it was reported by a sales representative via email that the blade of the flipcutter iii from an ar-1288qis-100 quadlink implant system broke off during drilling.Due to this, the surgeon had to drill a larger tunnel, leading to having to use button extenders.This was discovered during a procedure on (b)(6)2024.Additional information received on 12/26/2024: this was discovered during an acl reconstruction procedure.All the broken fragments were removed.The case was completed by completing the reaming process with another reamer, which resulted in the use of a button extender.The case was delayed between ten to twenty minutes; however, the sales representative does not know if additional anesthesia was used.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.One unpackaged flipcutter iii drill that is part of an ar-1288qis-100 quadlink implant system was received for investigation.Visual evaluation of the returned device noted that the device was disassembled.Further visual evaluation noted the tip of the device was damaged.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 of the device due to misaligned insertion, excessive mechanical forces and/or prying/leveraging the device during use.Refer to investigation photos.Complaint allegation is confirmed.

• 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: 21138362
• Report Number: 1220246-2025-09383
• Device Sequence Number: 6829705
• Product Code: MBI
• UDI-Device Identifier: 00888867344754
• UDI-Public: (01)00888867344754(11)240701(17)280531(10)15280763
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 06/11/2025

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, 10MM
• Device Catalogue Number: AR-1288QIS-100
• Device Lot Number: 15280763
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2024
• Supplement Date Received by Manufacturer: 06/03/2025
• Initial Report FDA Received Date: 01/13/2025
• Supplement Report FDA Received Date: 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2024
• 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