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 (b)(4) that (qty.2) ar-8916vnc-22 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: 23957120
• Report Number: 1220246-2026-00036
• Device Sequence Number: 15855691
• 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