BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE IMPACTION DRILL

    MDR report key: 2935936 · Received January 30, 2013

    Report

    Report Number
    0001811755-2013-00119
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    January 11, 2013
    Report Date
    January 15, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    DZJ
    PMA / PMN Number
    K040369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE DEVICE EVALUATION, THE REPORTED SMOKING COULD NOT BE DUPLICATED, BECAUSE THE DEVICE WAS NOT RECOGNIZED BY THE CONSOLE. HOWEVER, THE PRINTED CIRCUIT BOARD (FLEX ASSEMBLY) WAS FOUND TO BE BURNT, WHICH WAS IDENTIFIED AS A PROBABLE CAUSE OF THE REPORTED SMOKING.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION HAS BEEN PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE AT THE USER FACILITY, THE DRILL WAS SMOKING FROM THE CORD END. BACK-UP EQUIPMENT WAS USED TO COMPLETE THE PROCEDURE. NO DELAY, NO ADVERSE CONSEQUENCES AND NO MEDICAL INTERVENTION WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE AT THE USER FACILITY, THE DRILL WAS SMOKING FROM THE CORD END. BACK-UP EQUIPMENT WAS USED TO COMPLETE THE PROCEDURE. NO DELAY, NO ADVERSE CONSEQUENCES AND NO MEDICAL INTERVENTION WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40820 CORE IMPACTION DRILL DRIVER, WIRE, AND BONE DRILL, MANUAL DZJ STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1