BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAESTRO DRILL

    MDR report key: 2123330 · Received June 8, 2011

    Report

    Report Number
    1811755-2011-02082
    Event Type
    Malfunction
    Date Received
    June 8, 2011
    Date of Event
    May 11, 2011
    Report Date
    May 11, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HBB
    PMA / PMN Number
    K041754
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER AND THE EVENT WAS CONFIRMED. THE HOSE ASSEMBLY WAS FOUND TO BE WORN AND DEGRADED. THE HOSE ASSEMBLY WAS REPLACED AND THE DRILL WAS RETURNED TO THE USER FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS LEAKING NON-STERILE OIL FROM THE CABLE DURING CLEANING. 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