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

Model Number	QUADLINK IMPLANT SYSTEM, 9MM
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 02/13/2023, it was reported by a sales representative via sems that a ar-1288qis-90 quadlink implant system had the incorrect size harvester.This occurred during an acl reconstruction on (b)(6) 2023 the initial cut on the quadriceps tendon measured a 9mm graft.The graft would not fit into the harvester from the kit.A ar-2386-10 10mm harvester was opened but was much too large.A ar-2386-09 9mm harvester was opened and compared to the size of the original harvester and determined to be larger.It was determined that the harvester from the ar-1288qis-90 kit was an 8mm.Additional information requested.
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.The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.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.As no further investigation was able to be performed no change in harm was identified.This complaint will be included in trending per (b)(4).

• 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: 19248361
• Report Number: 1220246-2024-02814
• Device Sequence Number: 6590441
• Product Code: MBI
• UDI-Device Identifier: 00888867344747
• UDI-Public: 00888867344747
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/06/2024

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, 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: 02/13/2023
• Initial Report FDA Received Date: 05/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown