BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6.5CM ADULT CRANI ATTACHMENT

    MDR report key: 3111955 · Received May 14, 2013

    Report

    Report Number
    1045834-2013-02135
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 15, 2013
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ATTACHMENT DEVICE WAS RECEIVED FOR EVALUATION. THE ATTACHMENT DEVICE WAS EVALUATED AND THE PROTECTIVE FOOT AND BACK POST WAS DRILLED INTO AND BROKEN OFF. EVIDENCE INDICATED THIS WAS DUE TO MISUSE, USAGE/WEAR OVER TIME. THE REPORTED CONDITION WAS CONFIRMED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE USA STATING THAT DURING STERILE PROCESSING THE ATTACHMENT DEVICE WAS FOUND TO HAVE A ¿BROKEN TIP.¿ THE DEVICE WAS NOT BEING USED IN SURGERY. THERE WERE NO INJURIES OR MEDICAL INTERVENTION REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211921 6.5CM ADULT CRANI ATTACHMENT MOTOR, DRILL, ELECTRIC-ATTACHMENT HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1