BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAESTRO DRILL WITH HANDSWITCH

    MDR report key: 2963043 · Received January 24, 2013

    Report

    Report Number
    1811755-2013-90115
    Event Type
    Malfunction
    Date Received
    January 24, 2013
    Date of Event
    December 20, 2012
    Report Date
    December 20, 2012
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HBB
    PMA / PMN Number
    K041754
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL COMPONENTS WERE EVALUATED WHICH REVEALED THAT THE NEEDLE VALVE OF THE HANDSWITCH HAD FAILED. THE REASON FOR THE SERIALIZATION STARTING WITH (B)(4) ISD TO PROVIDE CLARIFICATION FOLLOWING A CHANGE IN STRYKER'S ELECTRONIC COMPLAINT SYSTEMS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE THE DEVICE OPERATED AUTOMATICALLY WITHOUT USER ACTIVATION. A BACK-UP DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE AND AND NO ADVERSE CONSEQUENCES ALLEGED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34849 MAESTRO DRILL WITH HANDSWITCH HBB STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK