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

Model Number	2.4 X 18MM VAL SCREW, TI
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On (b)(6) 2025, a sales representative reported via phone that an ar-8916vnl-03 volar distal radius plate and two ar-8724v-18 low profile va locking screws failed during a volar distal radius orif procedure on (b)(6) 2025.While inserting the screws into the two most distal holes of the plate using an ar-8916tl-011 torque limiter, the screws did not lock into the plate and passed straight through.The plate and screws were removed from the patient, and the case was completed using a replacement ar-8916vnl-03 plate and two new low profile va locking screws.The patient had softer bone, which had been prepared using an elevator.The case was delayed approximately 5¿10 minutes, requiring additional anesthesia.There was no harm to the patient.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint allegation is not confirmed.One unpackaged ar-8724v-18 serial/batch number unknown was received for investigation.Functional testing was performed and showed the device functions as intended.Visual inspection noted no signs of significant damage on the device.No problem found.

• Brand Name: 2.4 X 18MM VAL 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: 23718979
• Report Number: 1220246-2025-05424
• Device Sequence Number: 10350103
• Product Code: HRS
• UDI-Device Identifier: 00888867045613
• UDI-Public: 00888867045613
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K131474
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2026

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 SCREW, TI
• Device Catalogue Number: AR-8724V-18
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2025
• Supplement Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown