BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORDLESS DRIVER 2 HANDPIECE

    MDR report key: 2844907 · Received November 2, 2012

    Report

    Report Number
    1811755-2012-03973
    Event Type
    Malfunction
    Date Received
    November 2, 2012
    Date of Event
    October 22, 2012
    Report Date
    October 22, 2012
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HRX
    PMA / PMN Number
    K943323
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO A SURGICAL PROCEDURE AT THE USER FACILITY, THE DEVICE WAS PRODUCING METAL SHAVINGS IN THE STERILE FIELD. NO PT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE ALLEGED 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 1/4" DRILL, CATALOG # 4100131000| SERIAL # (B)(4)