BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORDLESS DRIVE 2 HANDPIECE

    MDR report key: 2121130 · Received May 4, 2011

    Report

    Report Number
    1811755-2011-01597
    Event Type
    Malfunction
    Date Received
    May 4, 2011
    Date of Event
    April 4, 2011
    Report Date
    April 7, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    GET
    PMA / PMN Number
    K943323
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED AT THE MANUFACTURER FOR INVESTIGATION. AN EVALUATION WAS CONDUCTED AND THE COMPLAINT WAS CONFIRMED. ACCORDING TO THE INVESTIGATION DETAILS THE DEVICE FAILED AS A RESULT FROM A FAULTY THIRD PARTY ASIC (MOTOR CONTROLLER). THE HANDPIECE SHOWS SIGNS OF TAMPERING AND OTHER THIRD PARTY COMPONENTS. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HANDPIECE OVERHEATED. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT OR ANY ADVERSE CONSEQUENCES. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORDLESS DRIVE 2 HANDPIECE GET STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK