BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPAIR CORE MICRO DRILL

    MDR report key: 1911865 · Received November 23, 2010

    Report

    Report Number
    1811755-2010-01799
    Event Type
    Malfunction
    Date Received
    November 23, 2010
    Date of Event
    October 27, 2010
    Report Date
    October 27, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    DZJ
    PMA / PMN Number
    K040369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE HANDPIECE WAS REC'D AT THE MFR FOR SERVICE AND EVAL. THE INITIAL COMPLAINT COULD NOT BE VERIFIED. BASED ON THE INVESTIGATION DETAILS, THE HANDPIECE PASSED ALL TESTING, BUT THE MOTOR WAS FOUND TO BE CORRODED. THE MOTOR ASSEMBLY WAS REPLACED.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPAIR CORE MICRO DRILL POWERED SIMPLE CRANIAL DRILLS, BURRS, TREPHINES, A DZJ STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK