MAUDE Adverse Event Report: ARTHREX, INC. QUADLINK IMPLANT SYSTEM, 9MM; POLYETHYLENE SYNTHETIC SUTURE

Model Number	QUADLINK IMPLANT SYSTEM, 9MM
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On (b)(6) 2023, it was reported by a sales representative via (b)(4)that an ar-1288qis-90 quadlink implant system had an issue during an acl reconstruction procedure on (b)(6) 2023.When drilling the tunnel in the tibia, there was a strange noise, and then after assessing the flipcutter, the end of the mechanism came off completely.A piece broke off inside the patient and was retrieved.They had drilled the femur with the same flipcutter without issue.A new flipcutter with an unknown part and lot number was used to complete the procedure successfully.This occurred during use with no patient harm.Additional information has been requested.On (b)(6) 2023, the sales representative provided the following information via email: there was no adverse effect reported and no case delay.The femur was drilled previously with the same complaint device without issues before the complaint device then broke in the tibia while drilling the tunnel.The complaint device has been discarded.
Additional Manufacturer Narrative
Complaint allegation was confirmed upon evaluation the customer attached pictures.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(s) for the reported failure can be a user error due to improper bone preparation, misaligned insertion, and/or prying/levering the device during insertion.

• Brand Name: QUADLINK IMPLANT SYSTEM, 9MM
• 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: 17897966
• Report Number: 1220246-2023-08112
• Device Sequence Number: 7119449
• Product Code: GAT
• UDI-Device Identifier: 00888867344747
• UDI-Public: 00888867344747
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 10/25/2024

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, 9MM
• Device Catalogue Number: AR-1288QIS-90
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2023
• Supplement Date Received by Manufacturer: 10/09/2024
• Initial Report FDA Received Date: 10/09/2023
• Supplement Report FDA Received Date: 10/25/2024
• 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