BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE IMPACTION DRILL

    MDR report key: 2974644 · Received January 17, 2013

    Report

    Report Number
    1811755-2013-90105
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Date of Event
    December 21, 2012
    Report Date
    December 21, 2012
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    DZJ
    PMA / PMN Number
    K040369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS IS IN PROGRESS; ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT THE USER FACILITY, THE DRILL WAS OVERHEATING UPON RECEIPT. NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27304 CORE IMPACTION DRILL DZJ STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK