BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAESTRO DRILL

    MDR report key: 2123321 · Received June 8, 2011

    Report

    Report Number
    1811755-2011-02064
    Event Type
    Malfunction
    Date Received
    June 8, 2011
    Date of Event
    May 10, 2011
    Report Date
    May 10, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HBB
    PMA / PMN Number
    K041754
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER AND THE REPORTED FAILURE WAS CONFIRMED. THE EXHAUST HOSE ON THE MOTOR HOSE ASSEMBLY WAS FOUND TO BE WORN AND DEGRADED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE IS A HOLE IN THE TUBING. THIS WAS NOTICED DURING SETUP FOR A CASE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAESTRO DRILL HBB STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK