BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORDLESS DRIVER 3

    MDR report key: 3240227 · Received July 22, 2013

    Report

    Report Number
    0001811755-2013-01747
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    June 27, 2013
    Report Date
    July 9, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HRX
    PMA / PMN Number
    K943323
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED AFTER THE QUALITY INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    DURING DEVICE EVALUATION, THE REPORTED EVENT COULD NOT BE DUPLICATED. THE COMPONENTS OF THE DEVICE WERE VISUALLY EXAMINED AND FOUND TO BE CONFORMING. PREVENTATIVE MAINTANENCE WAS PERFORMED ON THE DEVICE AND IT WAS RETURNED TO THE USER FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING TESTING AT THE USER FACILITY THAT THE CORDLESS DRIVER 3 WAS PRODUCING METAL SHAVINGS. NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING TESTING AT THE USER FACILITY THAT THE CORDLESS DRIVER 3 WAS PRODUCING METAL SHAVINGS. NO PATIENT 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
    339656 CORDLESS DRIVER 3 ARTHROSCOPE HRX STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1