BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE IMPACTION DRILL

    MDR report key: 1970362 · Received January 18, 2011

    Report

    Report Number
    1811755-2011-00150
    Event Type
    Malfunction
    Date Received
    January 18, 2011
    Date of Event
    December 29, 2010
    Report Date
    December 29, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    DZJ
    PMA / PMN Number
    K040369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED FOR EVAL AND OVERHEATING WAS DUPLICATED DURING THE QUALITY INVESTIGATION TESTING. FURTHER EVAL REVEALED A BROKEN BALANCES ROTOR AND CORE DRIVESHAFT. THESE PARTS AND OTHER COMPONENT PARTS WERE REPLACED, CLEANED AND LUBED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A STRYKER CORE IMPACTION DRILL OVERHEATED DURING A WISDOM TOOTH EXTRACTION. NO ADVERSE CONSEQUENCES WERE REPORTED AS A RESULT OF THIS EVENT. ANOTHER DRILL WAS USED TO COMPLETE THE PROCEDURE WITHOUT ANY PROCEDURE DELAY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK