BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORDLESS DRIVER 2 HANDPIECE

    MDR report key: 2391979 · Received December 14, 2011

    Report

    Report Number
    1811755-2011-04552
    Event Type
    Malfunction
    Date Received
    December 14, 2011
    Date of Event
    November 16, 2011
    Report Date
    November 17, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HRX
    PMA / PMN Number
    K943323
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ORTHOPAEDIC PROCEDURE, METAL SHAVINGS WERE VISIBLE AROUND THE ATTACHMENT AREA OF THE HANDPIECE. NONE OF THE SHAVINGS GOT INTO THE SURGICAL SITE. A BACKUP UNIT WAS AVAILABLE TO COMPLETE THE PROCEDURE. THERE WERE NO ALLEGATIONS OF ADVERSE CONSEQUENCES ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORDLESS DRIVER 2 HANDPIECE HRX STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK