BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CALCANAIL

    MDR report key: 10337799 · Received July 29, 2020

    Report

    Report Number
    3003898228-2020-00006
    Event Type
    Malfunction
    Date Received
    July 29, 2020
    Date of Event
    July 10, 2020
    Report Date
    August 15, 2020
    Manufacturer
    FH INDUSTRIE
    Product Code
    HSB
    PMA / PMN Number
    K150463
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE THREADED TREPHINE D12 HAS SHATTED IN USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    800916 CALCANAIL CALCANAIL AO LARGE THREADED TREPHINE D12 L140 HSB FH INDUSTRIE 267056

    Patients

    Seq Age Sex Outcome Treatment
    1