MAUDE Adverse Event Report: ARTHREX, INC. VAL KREULOCK SCREW, TI, 2.4X20; BONE FIXATION PLATE/SCREW

Model Number	VAL KREULOCK SCREW, TI, 2.4X20
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2025
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 10/17/2025, a sales representative reported via phone that an ar-8916vnr-03 volar distal radius plate and an ar-8724vcl-20 kreulock¿ compression screw failed.This occurred during a distal radius fracture on (b)(6) 2025.After placing the small 2.4 screws into the plate, the surgeon proceeded to insert the ar-8724vcl-20 screw into the plate, but the screw went straight through the plate.The surgeon proceeded to remove the plate and all the screws, including the one that went through the plate.The case continued using another ar-8916vnr-03 volar distal radius plate and another ar-8724vcl-20 kreulock¿ compression screw, along with the same 2.4 screws that were first attempted.The patient's bone was prepped using an ar-8916-14 drill bit.There was about a 10-minute delay that did not require additional anesthesia.There was no harm to the patient.Additional information was provided on 10/17/2025 where the sales representative reported that the patient had good bone quality.
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 use-related factors during screw insertion, such as excessive force/torque when implanting the screw.

• Brand Name: VAL KREULOCK SCREW, TI, 2.4X20
• Common Device Name: BONE FIXATION PLATE/SCREW
• 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: 23418099
• Report Number: 1220246-2025-04882
• Device Sequence Number: 10381093
• Product Code: HRS
• UDI-Device Identifier: 00888867323988
• UDI-Public: (01)00888867323988(11)250121(10)15375819
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K201132
• 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): 03/03/2026

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: VAL KREULOCK SCREW, TI, 2.4X20
• Device Catalogue Number: AR-8724VCL-20
• Device Lot Number: 15375819
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 10/17/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2025
• Supplement Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 10/29/2025
• Supplement Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown