BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELEGRAPH EVO

    MDR report key: 22896066 · Received August 26, 2025

    Report

    Report Number
    3003898228-2025-00002
    Event Type
    Malfunction
    Date Received
    August 26, 2025
    Date of Event
    July 27, 2025
    Report Date
    September 6, 2025
    Manufacturer
    FH INDUSTRIE
    Product Code
    HSB
    PMA / PMN Number
    K200127
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING THE PROCEDURE, THE NAIL ENCOUNTERED RESISTANCE, CAUSING DISTRACTION OF THE FRACTURE SITE, STILL UNDER FLUOROSCOPIC CONTROL. AN ATTEMPT WAS MADE TO REMOVE THE NAIL IN A CONTROLLED MANNER IN ORDER TO REINSERT A FINISHING REAMER (SMOOTHING REAMER), BUT THE NAIL FRACTURED: THE DISTAL END, APPROXIMATELY 5 CM LONG, REMAINED LOCKED IN THE DISTAL FRAGMENT OF THE HUMERUS. THE LIMB IS IMMOBILISED USING A RESIN BABP DEVICE AND CLOSE MONITORING IS PLANNED. DRESSINGS MUST BE CHANGED EVERY TWO DAYS AND THE STITCHES REMOVED ON DAY 14.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2666451 TELEGRAPH EVO TELEGRAPH EVO LONG CANNULATED HUMERAL NAIL RIGHT D7 L250 HSB FH INDUSTRIE M03416

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Male Other