MAUDE Adverse Event Report: ARTHREX, INC. 2.4 X 18MM VAL NEAR CORTEX SCREW, TI; BONE FIXATION PLATE

Model Number	2.4 X 18MM VAL NEAR CORTEX SCREW, TI
Medical Device Problem Codes	Use of Device Problem (1670); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 6/17/2025, a sales representative reported via phone that an ar-8916vnl-03 volar distal radius plate and an ar-8916vnc-18 screw had an issue during a distal radius fracture procedure on (b)(6) 2025.When the surgeon was inserting the screw, using a handriver, he felt like the screw was not working correctly, and noticed that the screw went though the plate during insertion.The surgeon removed the screw and the plate from the patient.Nothing broke inside the patient, and there was no harm.An x-ray was taken, and the complaint devices were available for return.Another ar-8916vnl-03 volar distal radius plate and an ar-8916vnc-18 screw with the same lot numbers were used to complete the procedure successfully.The case was slightly delayed by under 15 minutes, and no additional anesthesia was administered.This occurred during use with no reported patient harm.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.One unpackagedar-8916vnc-18, batch 15401930, was received for evaluation.Visual inspection revealed surface damage to the screw's head and threads, likely resulting from the implantation and explantation process.Measurement of the critical dimensions were found to be within the specifications of drawing c8058.Functional testing was conducted by securing the screw to the plate.However, when excess force was applied, the screws were pushed through the holes, consistent with the findings observed with the patient's x-ray.The most likely cause of the reported failure is user error, specifically the application of excessive force.The complaint allegation is confirmed.Refer to the investigation photos.

• Brand Name: 2.4 X 18MM VAL NEAR CORTEX SCREW, TI
• Common Device Name: BONE FIXATION PLATE
• 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: 22481783
• Report Number: 1220246-2025-02836
• Device Sequence Number: 12928764
• Product Code: HRS
• UDI-Device Identifier: 00888867130739
• UDI-Public: (01)00888867130739(11)250310(10)15401930
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K150456
• 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): 10/08/2025

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: 2.4 X 18MM VAL NEAR CORTEX SCREW, TI
• Device Catalogue Number: AR-8916VNC-18
• Device Lot Number: 15401930
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Distributor Facility Aware Date: 06/17/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2025
• Supplement Date Received by Manufacturer: 10/01/2025
• Initial Report FDA Received Date: 07/11/2025
• Supplement Report FDA Received Date: 10/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown