MAUDE Adverse Event Report: ARTHREX, INC. 2.4 X 22MM VAL NEAR CORTEX SCREW, TI; BONE FIXATION PLATE

Model Number	2.4 X 22MM VAL NEAR CORTEX SCREW, TI
Medical Device Problem Codes	Failure to Advance (2524); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 15-dec-2025, a facility representative reported via sems (b)(4) that (qty.2) (b)(6) 2.4 mm x 22 mm low-profile locking screws would not thread into the plate, but the third one worked.This was discovered during a case with no patient affected.Additional information was received on 17-dec-2025.The rep advised the event occurred during an open reduction internal fixation of a distal radius fracture.A 1.7 drill bit and a correct guide were used prior to inserting the screw, and the bone quality was adequate.Nothing broke, and no additional screws or plates contained a product allegation.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided ¿ which may include the returned device (if available), photographs, videos, event description, and any additional field input ¿ arthrex has determined the most likely cause.The most likely cause is attributed to user-related factors, such as plate screw misalignment or incomplete plate seating.

• Brand Name: 2.4 X 22MM VAL NEAR CORTEX 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: 23957126
• Report Number: 1220246-2026-00037
• Device Sequence Number: 9611110
• Product Code: HRS
• UDI-Device Identifier: 00888867130753
• UDI-Public: (01)00888867130753(11)180215(10)1001809
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 04/20/2026

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: 2.4 X 22MM VAL NEAR CORTEX SCREW, TI
• Device Catalogue Number: AR-8916VNC-22
• Device Lot Number: 1001809
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 12/15/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2025
• Supplement Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/15/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown