BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORE IMPACTION DRILL

    MDR report key: 2081238 · Received April 26, 2011

    Report

    Report Number
    1811755-2011-01424
    Event Type
    Injury
    Date Received
    April 26, 2011
    Date of Event
    March 29, 2011
    Report Date
    March 29, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    DZJ
    PMA / PMN Number
    K040369
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING QUALITY INVESTIGATION, THE CUSTOMER'S COMPLAINT COULD WAS DUPLICATED; THE DEVICE OVERHEATED DURING TESTING. UPON DISASSEMBLY OF THE DEVICE, A DAMAGED MOTOR, ROTOR, DRIVESHAFT, AND OTHER COMPONENT PARTS WERE NOTED. CORROSION DAMAGE TO THE MOTOR CARTRIDGE WAS IDENTIFIED AS THE PROBABLE CAUSE OF THE FAILURE. THE DAMAGED PARTS WERE REPLACED, PREVENTIVE MAINTENANCE DONE AND THE DEVICE WAS REPAIRED ADN RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE STRYKER CORE IMPACTION DRILL WAS SENT IN FOR REPAIR BECAUSE IT OVERHEATED AND BURNED THE PT'S LIP DURING AN ORAL PROCEDURE. THE BURN WAS A 1CM BY 1CM SECOND DEGREE BURN ON THE WET DRY LINE OF THE LOWER LIP ON THE RIGHT SIDE. ACCORDING TO THE PHYSICIAN, SCARRING MAY OR MAY NOT OCCUR. THE BURN WAS TREATED WITH A STEROID CREAM AND BACITRACIN OINTMENT. THE PHYSICIAN HAS NOT EVALUATED THE PT SINCE THE EVENT OCCURRED AS THE PT HAS NOT RETURNED FOR A FOLLOW UP.

    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 21 YR Other