BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO SAGITTAL SAW

    MDR report key: 3233858 · Received July 18, 2013

    Report

    Report Number
    0001811755-2013-01683
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 29, 2013
    Report Date
    June 29, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HBE
    PMA / PMN Number
    K032303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT OF A BIAS CURRENT ERROR WAS NOT DUPLICATED; HOWEVER, IT WAS CONFIRMED THROUGH INSPECTION THAT THE MOTOR ASSEMBLY INCLUDING THE TPS FLEX WAS CORRODED.

    Additional Manufacturer Narrative · 1

    DEVICE NOT YET RECEIVED. EVALUATION IS ANTICIPATED UPON RECEIPT OF DEVICE AND A FOLLOW-UP WILL BE FILED.

    Description of Event or Problem · 1

    THE MICRO SAGITTAL SAW WAS TESTED DURING ROUTINE SERVICING. UPON EVALUATION IT DISPLAYED A BIAS CURRENT MESSAGE WHEN CONNECTED TO THE CONSOLE, SIGNALING A CONDITION OCCURRED FROM WHICH THE DEVICE HAS THE POTENTIAL TO RUN WITHOUT USER ACTIVATION. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES TO THE USER ALLEGED WITH THIS EVENT.

    Description of Event or Problem · 1

    THE MICRO SAGITTAL SAW WAS TESTED DURING ROUTINE SERVICING. UPON EVALUATION IT DISPLAYED A BIAS CURRENT MESSAGE WHEN CONNECTED TO THE CONSOLE, SIGNALING A CONDITION OCCURRED FROM WHICH THE DEVICE HAS THE POTENTIAL TO RUN WITHOUT USER ACTIVATION. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES TO THE USER ALLEGED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334522 MICRO SAGITTAL SAW DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1