BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELEGRAPH EVO

    MDR report key: 17834667 · Received September 28, 2023

    Report

    Report Number
    3003898228-2023-00005
    Event Type
    Malfunction
    Date Received
    September 28, 2023
    Date of Event
    August 25, 2023
    Report Date
    January 26, 2024
    Manufacturer
    FH INDUSTRIE
    Product Code
    HSB
    UDI-DI
    03661489708121
    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 A SURGICAL PROCEDURE, A CENTROMEDULAR NAILING OF THE HUMERUS USING A NEW TRIAL ANCILLARY (TELEGRAPH LONG FH NAIL) THE NAIL HOLDER BROKE AT THE LEVEL OF THE SCREW THREAD, REMAINING IN THE NAIL. DIFFICULTY TO BE EXPECTED WHEN REMOVING OSTEOSYNTHESIS MATERIAL.

    Description of Event or Problem · 0

    DURING A SURGICAL PROCEDURE, A CENTROMEDULAR NAILING OF THE HUMERUS USING A NEW TRIAL ANCILLARY (TELEGRAPH LONG FH NAIL) THE NAIL HOLDER BROKE AT THE LEVEL OF THE SCREW THREAD, REMAINING IN THE NAIL. DIFFICULTY TO BE EXPECTED WHEN REMOVING OSTEOSYNTHESIS MATERIAL.

    Description of Event or Problem · 0

    DURING A SURGICAL PROCEDURE, A CENTROMEDULAR NAILING OF THE HUMERUS USING A NEW TRIAL ANCILLARY (TELEGRAPH LONG FH NAIL) THE NAIL HOLDER BROKE AT THE LEVEL OF THE SCREW THREAD, REMAINING IN THE NAIL. DIFFICULTY TO BE EXPECTED WHEN REMOVING OSTEOSYNTHESIS MATERIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2010975 TELEGRAPH EVO TELEGRAPH EVO CANNULATED CONNECTING SCREW FOR NAIL HSB FH INDUSTRIE NA UNKNOWN 03661489708121

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other