BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE IMPACTION DRILL

    MDR report key: 3913130 · Received July 3, 2014

    Report

    Report Number
    0001811755-2014-02384
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    June 6, 2014
    Report Date
    June 6, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    DZJ
    PMA / PMN Number
    K040369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS THIS PRODUCT WAS NOT RETURNED FOR EVALUATION, THE FAILURE MODE COULD NOT BE CONFIRMED. DEVICE NOT RETURNED TO MANUFACTURER FOR INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE AT THE USER FACILITY THE CORE IMPACTION DRILL WAS OVERHEATING. IT WAS REPORTED THAT THERE WAS NO PROCEDURE ASSOCIATED WITH THIS EVENT. THE USER FACILITY WAS NOT ABLE TO PROVIDE ANY FURTHER INFORMATION REGARDING THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390352 CORE IMPACTION DRILL DRIVER, WIRE, AND BONE DRILL, MANUAL DZJ STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1