MAUDE Adverse Event Report: ARTHREX, INC. QUADLINK IMPLANT SYSTEM, 9MM; NON-DEGRADABLE FIXATION FASTENER

Model Number	QUADLINK IMPLANT SYSTEM, 9MM
Medical Device Problem Code	Device Misassembled During Manufacturing /Shipping (2912)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On 05/24/2022, it was reported arthrex employee via phone that a ar-1288qis-90 acl tightrope kit has a quad pro harvester that is a 8mm and should be a 9mm.This was discovered during a quad acl when the device would not cut the graft properly, this was the result of the device measuring to shorting.The case was completed using a ar-2386-09.There was no patient effect reported.
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.Device was discarded by facility.The most likely cause for the reported failure can be attributed to a manufacturing issue; however, due to the device not being returned, we are unable to confirm the reported event.

• Brand Name: QUADLINK IMPLANT SYSTEM, 9MM
• Common Device Name: NON-DEGRADABLE FIXATION 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: 19286231
• Report Number: 1220246-2024-03087
• Device Sequence Number: 18249304
• Product Code: MBI
• UDI-Device Identifier: 00888867344747
• UDI-Public: 00888867344747
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K231857
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/10/2024

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 Expiration Date: 12/31/2025
• Device Model Number: QUADLINK IMPLANT SYSTEM, 9MM
• Device Catalogue Number: AR-1288QIS-90
• Device Lot Number: 14728919
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2022
• Initial Report FDA Received Date: 05/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown