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

Model Number	VOLAR DISTAL RAD PLT TI STD LT 5H
Medical Device Problem Codes	Use of Device Problem (1670); Defective Device (2588)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2025
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 5/9/2025, a sales representative reported via email that an ar-8724v-24 2.4mm distal locking screw threaded through the ar-8916vsl-05 volar distal radius plate instead of locking to it.The screw was removed and a second screw was implanted instead.The surgeon then, tried to use the faulty screw with a new plate and it threaded in without any issues.This was discovered during a procedure on (b)(6) 2025.No further information was provided.
Event or Problem Description
On (b)(6) 2025, a sales representative reported via email that an ar-8724v-24 2.4mm distal locking screw threaded through the ar-8916vsl-05 volar distal radius plate instead of locking to it.The screw was removed, and a second screw was implanted instead.The surgeon then, tried to use the faulty screw with a new hole of the plate and it threaded in without any issues.This was discovered during a procedure on (b)(6) 2025.No further information was provided.
Additional Manufacturer Narrative
Additional information: b5, h3, h6.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to user error of the device due to applying excessive mechanical forces during screw insertion and/or over-torquing the screw during insertion.

• Brand Name: VOLAR DISTAL RAD PLT TI STD LT 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: 22142109
• Report Number: 1220246-2025-02368
• Device Sequence Number: 12581779
• Product Code: HRS
• UDI-Device Identifier: 00888867131019
• UDI-Public: 00888867131019
• 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: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/14/2025

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 LT 5H
• Device Catalogue Number: AR-8916VSL-05
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/09/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2025
• Supplement Date Received by Manufacturer: Not provided; 10/08/2025
• Initial Report FDA Received Date: 06/04/2025
• Supplement Report FDA Received Date: 06/27/2025; 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown