BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAESTRO DRILL WITH HANDSWITCH

    MDR report key: 3834503 · Received May 28, 2014

    Report

    Report Number
    0001811755-2014-01953
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Date of Event
    April 30, 2014
    Report Date
    April 30, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HBB
    PMA / PMN Number
    K041754
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS IS IN PROGRESS. A FOLLOW-UP WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    DURING FAILURE ANALYSIS, THE REPORTED EVENT OF THE DEVICE RUNNING IN SAFE MODE WAS CONFIRMED. THE DEVICE HAD A DAMAGED O-RING ON THE NEEDLE VALVE AND A BENT NEEDLE VALVE. DAMAGE TO THE O-RING CAN CAUSE THE NEEDLE VALVE TO STICK, KEEPING THE DEVICE ACTIVATED IN SAFE MODE. THE NEEDLE VALVE STICKING CAN CAUSE IT TO BEND, ALSO CONTRIBUTING TO THE EVENT OF RUN ON.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MAESTRO DRILL WITH HANDSWITCH EXPERIENCED UNINTENTIONAL ACTIVATION AND RAN IN SAFE MODE DURING DEVICE EVALUATION AT THE MANUFACTURING FACILITY. NO PATIENT INVOLVEMENT, NO ADVERSE CONSEQUENCES, NO MEDICAL INTERVENTION, AND NO SURGICAL DELAY WERE REPORTED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MAESTRO DRILL WITH HANDSWITCH EXPERIENCED UNINTENTIONAL ACTIVATION AND RAN IN SAFE MODE DURING DEVICE EVALUATION AT THE MANUFACTURING FACILITY. NO PATIENT INVOLVEMENT, NO ADVERSE CONSEQUENCES, NO MEDICAL INTERVENTION, AND NO SURGICAL DELAY WERE REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314411 MAESTRO DRILL WITH HANDSWITCH MOTOR, DRILL, PNEUMATIC HBB STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1