BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE IMPACTION DRILL

    MDR report key: 2241628 · Received September 2, 2011

    Report

    Report Number
    1811755-2011-03263
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    August 10, 2011
    Report Date
    August 10, 2011
    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

    WIDE SPREAD CORROSION WITHIN THE DEVICE WAS IDENTIFIED AS THE PROBABLE CAUSE OF THE OVERHEATING REPORTED.

    Description of Event or Problem · 1

    THE CORE IMPACTION DRILL WAS SENT IN FOR EVAL BECAUSE IT WAS OVERHEATING AND COMING APART DURING A PROCEDURE. NO ADVERSE EVENT WAS REPORTED. THE PROCEDURE WAS COMPLETED WITH A READILY AVAILABLE ALTERNATE DEVICE WITHOUT ANY PROCEDURE DELAY.

    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