MAUDE Adverse Event Report: ARTHREX, INC. VOLAR DISTAL RAD PLT TI STD RT 5H; BONE FIXATION PLATE

Model Number	VOLAR DISTAL RAD PLT TI STD RT 5H
Medical Device Problem Codes	Positioning Failure (1158); Defective Device (2588)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 3/25/2025, it was reported by a sales representative via email that a val screw advance straight through an ar-8916vsr-05 volar distal radius plate.The screw was removed, and another 2.4 val screw was inserted, but the same thing happened.This was discovered during a distal radius fracture procedure on (b)(6) 2025.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
Additional information was received on 4/18/2025: nothing broke inside the patient.The case was successfully completed with a new plate and screws.However, the procedure was delayed by approximately forty-five minutes, requiring the administration of additional anesthesia.Additional information was requested on 5/6/2025.
Additional Manufacturer Narrative
Additional information: b5, h3, h6.

• Brand Name: VOLAR DISTAL RAD PLT TI STD RT 5H
• 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: 21875101
• Report Number: 1220246-2025-01606
• Device Sequence Number: 15428676
• Product Code: HRS
• UDI-Device Identifier: 00888867131156
• UDI-Public: (01)00888867131156(11)240123(10)15132169
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 05/14/2025

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: VOLAR DISTAL RAD PLT TI STD RT 5H
• Device Catalogue Number: AR-8916VSR-05
• Device Lot Number: 15132169
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 03/25/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/21/2025
• Supplement Report FDA Received Date: 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/23/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown