BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAESTRO DRILL

    MDR report key: 2090698 · Received April 19, 2011

    Report

    Report Number
    1811755-2011-01310
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    February 24, 2011
    Report Date
    March 24, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HBB
    PMA / PMN Number
    K041754
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DRILL WAS RECEIVED BY THE MFR, HOWEVER THE COMPLAINT COULD NOT BE REPLICATED. THE DEVICE EVAL REVEALED THAT THE DRILL PERFORMED ACCORDING TO ALL SPECS, AND NO DAMAGE TO THE HOSE WAS DETECTED. DUE TO THE AGE OF THE DEVICE, THE HOSE ASSEMBLY WAS REPLACED FOR PREVENTATIVE MAINTENANCE PURPOSES. THE DRILL WAS RETURNED THE USER FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE USER FACILITY THAT THE PNEUMATIC DRILL WAS LEAKING AIR. THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE, SO THERE WAS NO PT INVOLVEMENT. NO USER INJURY WAS REPORTED, AND NO OTHER ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT.

    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