MAUDE Adverse Event Report: ARTHREX, INC. QUADLINK IMPLANT SYSTEM, 9MM; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	QUADLINK IMPLANT SYSTEM, 9MM
Medical Device Problem Code	Structural Problem (2506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2022
Type of Reportable Event	Malfunction
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.Since the complaint device was not returned, a physical/picture evaluation of the device was not performed.The most likely cause for the reported failure can be attributed to a manufacturing issue; however, due to the device not being returned, the complaint allegation is not confirmed.Capa-00389 and ncr-21199 was opened to address this issue.
Event or Problem Description
On 4/27/2023, it was reported by a sales representative via sems that the black plunger from an ar-1288qis-90 quadlink implant system, would not fit into the clear-cutting piece of the quadpro.The clear piece was not small and did not appear to be 9mm.This was discovered when the surgeon was ready to cut the quad graft during a quad aclr procedure on (b)(6) 2023.The case was completed with a new ar-1288qis-90 quadlink implant system.

• Brand Name: QUADLINK IMPLANT SYSTEM, 9MM
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• 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: 19508837
• Report Number: 1220246-2024-05524
• Device Sequence Number: 3404614
• Product Code: MBI
• UDI-Device Identifier: 00888867344747
• UDI-Public: 00888867344747
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K231857
• 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
• Report Date (Section B): 06/11/2024

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
• Device Lot Number: 15033375
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2023
• Initial Report FDA Received Date: 06/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown