BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORDLESS DRIVER 2 HANDPIECE

    MDR report key: 2200933 · Received July 1, 2011

    Report

    Report Number
    1811755-2011-02389
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    June 10, 2011
    Report Date
    June 13, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HRX
    PMA / PMN Number
    K943323
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MFR AND UPON INITIAL EVAL THE COMPLAINT COULD NOT BE CONFIRMED. THE ASIC MOTOR CONTROL AND ASSEMBLY NEEDED TO BE REPLACED IN ADDITION TO SEVERAL OTHER COMPONENTS. A F/U REPORT WILL BE SUBMITTED IF NEW INFO IS OBTAINED AND IF REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BLACK METAL CAME OUT OF THE HANDPIECE DURING A HAND PROCEDURE. THE METAL DID ENTER THE SURGICAL SITE BUT WAS EASILY RETRIEVED BY THE SURGEON. THE SITE WAS THEN IRRIGATED WITHOUT ANY ADVERSE CONSEQUENCES RELATED TO THE EVENT. THE SURGERY WAS COMPLETED WITHOUT DELAY WITH A BACK-UP DEVICE.

    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