MAUDE Adverse Event Report: ARTHREX, INC. QUADLINK IMPLANT SYSTEM, 11MM; POLYETHYLENE SYNTHETIC SUTURE

Model Number	QUADLINK IMPLANT SYSTEM, 11MM
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/14/2023
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 sems that an ar-1288qis-110 quadlink implant systems flipcutter wobbled when they ran the drill.They attempted a second time and it still appeared to wobble.This occurred during an acl reconstruction, an ar-1204ff was opened and the case was completed without issue.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint confirmed.One unpackaged ar-1288qis-110 was received for investigation.The returned devices were visually inspected, and it was identified that the cutting tip was broken off.The device's manual functional test was completed without issue.However, mechanical tests were not performed since the drill connector was unavailable.The most likely cause(s) of this type of event is a supplier manufacturing defect.

• Brand Name: QUADLINK IMPLANT SYSTEM, 11MM
• 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: 17710167
• Report Number: 1220246-2023-07820
• Device Sequence Number: 6717230
• Product Code: GAT
• UDI-Device Identifier: 00888867344761
• UDI-Public: 00888867344761
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 11/06/2024

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, 11MM
• Device Catalogue Number: AR-1288QIS-110
• Device Lot Number: 15101823
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2023
• Supplement Date Received by Manufacturer: 10/30/2023
• Initial Report FDA Received Date: 09/08/2023
• Supplement Report FDA Received Date: 11/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2023
• 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