BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO OSCILLATING SAW WITH XI BLADE MOUNT

    MDR report key: 1854428 · Received September 30, 2010

    Report

    Report Number
    1811755-2010-01285
    Event Type
    Malfunction
    Date Received
    September 30, 2010
    Date of Event
    September 10, 2010
    Report Date
    September 10, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE HANDPIECE WAS RECEIVED AT THE MANUFACTURER FOR EVALUATION, AND THE REPORTED CONDITION OF THE DEVICE OVERHEATING WAS DUPLICATED. BASED ON THE INVESTIGATION DETAILS, THE LIKELY CAUSE WAS PROBLEMS WITH ROTOR BEARINGS AND ROLLER BEARINGS, WHICH WERE EACH REPLACED ALONG WITH OTHER COMPONENTS. SERVICE REPAIRED AND RETURNED THE DEVICE TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HANDPIECE OVERHEATED DURING A ROUTINE MAINTENANCE VISIT AND IN A NON-STERILE ENVIRONMENT. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO ADVERSE CONSEQUENCES REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO OSCILLATING SAW WITH XI BLADE MOUNT SURGICAL INSTRUMENT MOTORS AND ACCESSORIES/ATTAC ERL STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK