BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAESTRO DRILL

    MDR report key: 2132321 · Received June 11, 2011

    Report

    Report Number
    1811755-2011-02089
    Event Type
    Malfunction
    Date Received
    June 11, 2011
    Date of Event
    May 23, 2011
    Report Date
    May 23, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HBB
    PMA / PMN Number
    K041754
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DRILL WAS RECEIVED BY THE MANUFACTURER AND THE COMPLAINT WAS CONFIRMED. THE DEVICE EVALUATION REVEALED THAT THE DRILL PERFORMED ACCORDING TO ALL SPECIFICATIONS, HOWEVER, A HOLE IN THE PNEUMATIC HOSE ASSEMBLY WAS CONFIRMED. IT IS UNKNOWN HOW THE HOSE DAMAGE OCCURRED, BUT MAY BE THE RESULT OF MISHANDLING. THE HOSE ASSEMBLY WAS REPLACED AND THE DRILL WAS RETURNED TO THE USER FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HOLE WAS DISCOVERED IN THE HOSE PORTION OF THE PNEUMATIC DRILL. THERE WAS NO REPORT OF ANY OIL LEAKAGE FROM THE DEVICE. THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE, SO THERE WAS NO PATIENT 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