MAUDE Adverse Event Report: ARTHREX, INC. QUADLINK IMPLANT SYSTEM, 10MM; POLYETHYLENE SYNTHETIC SUTURE

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	12/08/2023
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 12/8/2023, it was reported by a sales representative via (b)(4) that the flipcutter ii from an ar-1288qis-100 quadlink implant system tip broke.When the surgeon attempted to flip the blade and ream a tunnel, the tip broke.The fragments were retrieved and an ar-1204ff flipcutter iii was opened to complete the case.This was discovered during an aclr procedure on (b)(6) 2023.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint confirmed.One unpackaged ar-1288qis-100 was received for investigation.Upon visual evaluation, it was noted that the cutter tip was broken off.It was noted that the detached tip shaft was bent.Functional testing was not performed due to the damage to the device.The method of bone preparation employed during the procedure, as well as the bone quality encountered, was not provided.The most likely cause for the reported failure can be attributed to improper bone prep, misaligned insertion, and prying/leveraging the device during insertion.

• Brand Name: QUADLINK IMPLANT SYSTEM, 10MM
• Common Device Name: POLYETHYLENE SYNTHETIC SUTURE
• 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: emily shafer ; 8009337001
• MDR Report Key: 18453272
• Report Number: 1220246-2024-00134
• Device Sequence Number: 7034059
• Product Code: GAT
• UDI-Device Identifier: 00888867344754
• UDI-Public: 00888867344754
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K112990
• 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): 06/09/2025

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: 15098002
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2023
• Supplement Date Received by Manufacturer: 06/19/2024
• Initial Report FDA Received Date: 01/05/2024
• Supplement Report FDA Received Date: 06/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2023
• 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