BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK

    MDR report key: 24410838 · Received February 22, 2026

    Report

    Report Number
    1220246-2026-00794
    Event Type
    Malfunction
    Date Received
    February 22, 2026
    Date of Event
    June 1, 2023
    Report Date
    February 22, 2026
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    ON 23 JAN 2026, ARTHREX WAS NOTIFIED VIA EMAIL OF A CASE STUDY PUBLISHED ON JUNE 2023 BY THE FOOT ANKLE SURG TITLED ¿THE CHEVRON BUNIONECTOMY FOR MODERATE TO SEVERE HALLUX VALGUS DEFORMITY: EFFECTS OF PROCEDURAL FACTORS ON HALLUX VALGUS CORRECTION.¿ THE STUDY REVIEWED 58 PATIENTS AND IDENTIFIED EPIPHYSEAL DEFICIENCY RESULTING IN A FAILED FIXATION WITH TRIM-IT PINS IN 2 PATIENTS DURING THE 4.6-YEAR FOLLOW-UP PERIOD. REF: HARRISON HR, MURPHY GA, BETTIN CC, RICHARDSON DR, GREAR BJ. THE CHEVRON BUNIONECTOMY FOR MODERATE TO SEVERE HALLUX VALGUS DEFORMITY: EFFECTS OF PROCEDURAL FACTORS ON HALLUX VALGUS CORRECTION. FOOT ANKLE SURG. JUN 2023;29(4):373-379. DOI:10.1016/J.FAS.2023.03.002.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471477 UNK SCREW, FIXATION, BONE HWC ARTHREX, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown