BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO SAGITTAL SAW

    MDR report key: 2033713 · Received March 23, 2011

    Report

    Report Number
    1811755-2011-00917
    Event Type
    Malfunction
    Date Received
    March 23, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 23, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HBE
    PMA / PMN Number
    K032303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE QUALITY INVESTIGATION, THE CUSTOMER'S COMPLAINT WAS CONFIRMED; THE DEVICE WAS RUNNING WHILE IT WAS ON SAFE MODE. FURTHER INVESTIGATION REVEALED CORROSION DAMAGE TO THE PRESS PLUG AND THE BEARING. THE LOW MOTOR CARTRIDGE WAS IDENTIFIED AS THE PRIMARY CAUSE OF THE FAILURE. THE DAMAGED PARTS WERE REPLACED AND THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    A STRYKER CORE IMPACTION DRILL WAS SENT IN FOR REPAIR BECAUSE IT WAS RUNNING ON ITS OWN DURING PREPARATION PRIOR TO A PROCEDURE. NO ADVERSE EVENT WAS ASSOCIATED WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO SAGITTAL SAW BONE CUTTING INSTRUMENT AND ACCESSORIES HBE STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK