MAUDE Adverse Event Report: ARTHREX, INC. VOLAR DISTAL RAD PLT TI NARROW LT 3H; BONE FIXATION PLATE

Model Number	VOLAR DISTAL RAD PLT TI NARROW LT 3H
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2025
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 11/17/2025, a sales representative reported via phone that an ar-8916vnl-03 volar distal radius plate and an ar-8724v-20 locking screw failed during a volar distal radius orif procedure on (b)(6) 2025.While inserting the screw into the most distal holes of the plate using an ar-8916tl-011 torque limiter, the screw did not lock into the plate and passed straight through.The plate and screw were removed from the patient, and the case was completed using a replacement ar-8916vnl-03 plate and another low-profile va locking screw.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-8916vnl-03 serial/batch number (b)(6) was received for investigation.- functional testing was performed, which revealed that the device functions as intended.- visual inspection noted that the device is used and seems to have visible signs of force being used on the device.- no problem found.

• Brand Name: VOLAR DISTAL RAD PLT TI NARROW LT 3H
• 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: 23719606
• Report Number: 1220246-2025-05428
• Device Sequence Number: 15565620
• Product Code: HRS
• UDI-Device Identifier: 00888867130852
• UDI-Public: (01)00888867130852(11)250710(10)15440626
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K150456
• 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: VOLAR DISTAL RAD PLT TI NARROW LT 3H
• Device Catalogue Number: AR-8916VNL-03
• Device Lot Number: 15440626
• 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
• Date Device Manufactured: 07/10/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown