MAUDE Adverse Event Report: ARTHREX, INC. Ø6X 20MM PEEK IF SCRW NON-VENTED; NON-DEGRADABLE FIXATN FASTENER

Model Number	Ø6X 20MM PEEK IF SCRW NON-VENTED
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an anterior cruciate ligament surgery during screwing into the bone the implant did not lock.There was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the part number ar-4020p-08.It was not necessary to switch the surgical technique or do a second surgery.
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.Complaint is confirmed.Visual inspection identified that the returned screw had been damaged at the base and threads.Functional testing was performed; the driver entered only up to half the length of the screw.The damage it has at the base of the screw did not allow it to enter completely.The method used to prepare the bone, as well as the bone quality encountered during the procedure, were not provided.Most likely cause can be attributed to improper bone preparation or prying/leveraging the screw during insertion.

• Brand Name: Ø6X 20MM PEEK IF SCRW NON-VENTED
• Common Device Name: NON-DEGRADABLE FIXATN 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: 19344928
• Report Number: 1220246-2024-03467
• Device Sequence Number: 20667547
• Product Code: MAI
• UDI-Device Identifier: 00888867294998
• UDI-Public: 00888867294998
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K180662
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/17/2024

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: 02/28/2026
• Device Model Number: Ø6X 20MM PEEK IF SCRW NON-VENTED
• Device Catalogue Number: AR-4020P-06
• Device Lot Number: 12914809
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2023
• Initial Report FDA Received Date: 05/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2021
• 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