BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE UNIVERSAL DRIVER

    MDR report key: 2121156 · Received May 4, 2011

    Report

    Report Number
    1811755-2011-01569
    Event Type
    Malfunction
    Date Received
    May 4, 2011
    Date of Event
    April 8, 2011
    Report Date
    April 8, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EVALUATED BY THE MANUFACTURER AND THE COMPLAINT WAS NOT DUPLICATED. THE EVALUATION DID FIND THAT CONTACT PINS IN THE POTTED TRIGGER ASSEMBLY WERE BURNT, THERE WAS EXCESSIVE GEAR NOISE, THE TEETH ON FACEGEAR AND PINION GEAR WERE DAMAGED AND THERE WERE CRACKS IN THE MOTOR FLEXSTRIP AND MINERAL DEPOSITS BUILT UP ON IT. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HANDPIECE CONTRIBUTED TO RUN ON ITS OWN DURING A SURGICAL PROCEDURE. THERE HAS BEEN NO REPORTED PATIENT OR USER INJURY, AND THE CASE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORE UNIVERSAL DRIVER ERL STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK