MAUDE Adverse Event Report: ARTHREX, INC. 2.4MM 2H L-PLATE, TI, 5H, LT; BONE FIXATION PLATE

Model Number	2.4MM 2H L-PLATE, TI, 5H, LT
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/27/2024
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 12/30/2024, it was reported by a sales representative via email that a screw went right through an ar-8952ml-05l l-plate during insertion.The screw had zero fixation against the plate.This was discovered during a distal radius fracture procedure on (b)(6) 2027.No further information was provided.Additional information requested.
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 excessive forces being used during insertion of the screw and/or misaligned insertion.

• Brand Name: 2.4MM 2H L-PLATE, TI, 5H, LT
• 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: 21218343
• Report Number: 1220246-2025-00059
• Device Sequence Number: 8640266
• Product Code: HRS
• UDI-Device Identifier: 00888867133402
• UDI-Public: 00888867133402
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K143749
• 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): 09/15/2025

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: 2.4MM 2H L-PLATE, TI, 5H, LT
• Device Catalogue Number: AR-8952ML-05L
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2024
• Supplement Date Received by Manufacturer: 09/09/2025
• Initial Report FDA Received Date: 01/23/2025
• Supplement Report FDA Received Date: 09/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown