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	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 9/1/2023, it was reported by a sales representative via sems-06021084 that an ar-1288qis-100 quadlink implant system, 10mm had an issue during an unspecified procedure on (b)(6) 2023.When they went to drill, the drill at the tip of the flipcutter iii broke off completely once it touched the bone.They were able to recover the broken drill bit.This occurred during use with no patient harm.Additional information has been requested.On 9/6/2023, the sales representative provided the following information via phone: this occurred during an acl reconstruction procedure.A flipcutter ii with an unknown part and lot number was used to complete the procedure successfully.There was a 2-minute case delay reported, but no adverse effect to the patient.The complaint device was discarded by the facility.
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.
Additional Manufacturer Narrative
Complaint allegation was not confirmed.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, 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: 17845047
• Report Number: 1220246-2023-08041
• Device Sequence Number: 4350115
• Product Code: GAT
• UDI-Device Identifier: 00888867344754
• UDI-Public: 00888867344754
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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, 10MM
• Device Catalogue Number: AR-1288QIS-100
• Device Lot Number: 15126154
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2023
• Supplement Date Received by Manufacturer: 10/09/2024
• Initial Report FDA Received Date: 09/29/2023
• Supplement Report FDA Received Date: 10/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2023
• 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