BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORDLESS DRIVER 2 HANDPIECE

    MDR report key: 3030712 · Received April 2, 2013

    Report

    Report Number
    0001811755-2013-00680
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 6, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HRX
    PMA / PMN Number
    K943323
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON DISASSEMBLY, THE BEARING WAS FOUND TO BE ROUGH/STICKY AND THE REAR MOTOR ASSEMBLY SHOWED SIGNS OF A THERMAL EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CORDLESS DRIVER 2 HANDPIECE HEATED UP DURING A CASE. A BACK-UP DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT OR USER INJURIES, AND NO ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134747 CORDLESS DRIVER 2 HANDPIECE ARTHROSCOPE HRX STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1