BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO SAGITTAL SAW

    MDR report key: 2121162 · Received May 4, 2011

    Report

    Report Number
    1811755-2011-01577
    Event Type
    Malfunction
    Date Received
    May 4, 2011
    Date of Event
    March 31, 2011
    Report Date
    April 7, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HBE
    PMA / PMN Number
    K032303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S COMPLAINT WAS CONFIRMED DURING FAILURE ANALYSIS; THE DEVICE RAN ON ITS OWN DURING TESTING. FURTHER INVESTIGATION REVEALED A DAMAGED MOTOR, ROTOR, BEARINGS, DRIVE SHAFT AND OTHER COMPONENT PARTS. THE DAMAGED PARTS WERE REPLACED, PREVENTIVE MAINTENANCE DONE AND THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE MICRO SAGITTAL SAW WAS SENT IN FOR EVALUATION BECAUSE IT WAS RUNNING WHILE IT WAS ON SAFE MODE. THERE WAS NO PATIENT INVOLVEMENT; NO ADVERSE EVENT WAS ASSOCIATED WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO SAGITTAL SAW HBE STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK