BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAESTRO DRILL WITH HANDSWITCH

    MDR report key: 2964251 · Received February 15, 2013

    Report

    Report Number
    0001811755-2013-00283
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 21, 2013
    Report Date
    January 21, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HBB
    PMA / PMN Number
    K041754
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL COMPONENTS WERE EVALUATED WHICH REVEALED THAT THE NEEDLE VALVE WAS BENT.

    Description of Event or Problem · 1

    CUSTOMER STATED THAT DURING TESTING PRIOR TO A PROCEDURE, THE DEVICE OPERATED AUTOMATICALLY WITHOUT USER ACTIVATION. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES ALLEGED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67190 MAESTRO DRILL WITH HANDSWITCH PNEUMATIC SURGICAL DRILLING SYSTEM HANDPIECE HBB STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1