BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE IMPACTION DRILL

    MDR report key: 2213834 · Received August 4, 2011

    Report

    Report Number
    1811755-2011-02809
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    June 23, 2011
    Report Date
    July 7, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    DZJ
    PMA / PMN Number
    K040369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EVALUATED BY THE MFR AND THE EVENT AS REPORTED BY THE CUSTOMER WAS NOT DUPLICATED. FURTHER INVESTIGATION IS PENDING. THIS REPORT WILL BE UPDATED WHEN THE EVAL IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DRILL STOPPED WORKING DURING A PROCEDURE. A SPARE DRILL WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A 30 MINUTE DELAY IN THE PROCEDURE. THERE WAS NO MEDICAL INTERVENTION REQUIRED AND NO ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORE IMPACTION DRILL DZJ STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK