BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOANER CORE SAG SAW

    MDR report key: 3173334 · Received June 17, 2013

    Report

    Report Number
    0001811755-2013-01411
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 4, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HBE
    PMA / PMN Number
    K032303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON DISASSEMBLY FOR VISUAL INSPECTION, THE FOLLOWING PARTS WERE WORN: THE BOOT, THE DRIVE BEARING AND THE ROTOR BEARING.

    Description of Event or Problem · 1

    THE CORE SAG SAW WAS RETURNED FOR SERVICE. UPON EVALUATION AT THE MANUFACTURER, 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. ADDITIONALLY, WHILE TESTING THE DEVICE DURING ROUTINE SERVICING, IT WAS REPORTED THAT THERE WAS A SUBSTANCE ON THE ROTOR ASSEMBLY WHICH COULD INDICATE THAT THE DEVICE WAS LEAKING. 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
    273051 LOANER CORE SAG SAW DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1