BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORDLESS DRIVER 3

    MDR report key: 2132286 · Received June 11, 2011

    Report

    Report Number
    1811755-2011-02112
    Event Type
    Malfunction
    Date Received
    June 11, 2011
    Date of Event
    April 15, 2011
    Report Date
    May 12, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HRX
    PMA / PMN Number
    K943323
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED AT THE MFR FOR INVESTIGATION. AN EVALUATION WAS CONDUCTED AND THE COMPLAINT WAS CONFIRMED. A FOLLOW-UP REPORT WILL BE COMPLETED ONCE THE FINAL INVESTIGATION HAS BEEN COMPLETED AND IF REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TESTING, THE DEVICE OVERHEATED. THERE WERE NO ADVERSE CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORDLESS DRIVER 3 HRX STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK