BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAESTRO MEDIUM FIXED DURAGUARD

    MDR report key: 3941193 · Received July 17, 2014

    Report

    Report Number
    0001811755-2014-02559
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 23, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HBB
    PMA / PMN Number
    K041754
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT OF A BENT TIP ON THE DURAGUARD WAS CONFIRMED BY A STRYKER SERVICE TECHNICIAN THROUGH VISUAL INSPECTION OF A BENT FOOT ON THE DURAGUARD. BASED ON THE RISK DOCUMENTATION A BENT DURAGUARD CAN OCCUR WHEN EXCESSIVE SIDE LOAD IS APPLIED TO THE FEATURE. DEVICE IS SCRAPPED BY STRYKER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE DURAGUARD WAS BENT ALLOWING FOR A CONDITION WHERE THE BUR/CUTTING ACCESSORY HAS THE POTENTIAL TO DAMAGE THE BLOOD VESSEL OR MEMBRANE. IT WAS FOUND DURING SET UP AT THE USER FACILITY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419745 MAESTRO MEDIUM FIXED DURAGUARD MOTOR, DRILL, PNEUMATIC HBB STRYKER INSTRUMENTS-KALAMAZOO 13247

    Patients

    Seq Age Sex Outcome Treatment
    1