MAUDE Adverse Event Report: ARTHREX, INC. 2.4 X 24MM VAL SCREW, TI; BONE FIXATION PLATE

Model Number	2.4 X 24MM VAL SCREW, TI
Medical Device Problem Codes	Use of Device Problem (1670); Failure to Advance (2524)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Date of Event	05/09/2025
Type of Reportable Event	Malfunction
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.Since all other screws had already been placed, it was decided to leave the misplaced screw in place to avoid disrupting the construct.This was discovered during a procedure.No further information was provided.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g2, 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 excessive forces being used during insertion of the screw.

• Brand Name: 2.4 X 24MM 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: 22141815
• Report Number: 1220246-2025-02365
• Device Sequence Number: 15234537
• Product Code: HRS
• UDI-Device Identifier: 00888867045644
• UDI-Public: 00888867045644
• 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): 10/07/2025

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 24MM VAL SCREW, TI
• Device Catalogue Number: AR-8724V-24
• 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: 09/30/2025
• Initial Report FDA Received Date: 06/04/2025
• Supplement Report FDA Received Date: 10/07/2025
• 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