BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE IMPACTION DRILL

    MDR report key: 2942064 · Received December 27, 2012

    Report

    Report Number
    1811755-2012-04353
    Event Type
    Malfunction
    Date Received
    December 27, 2012
    Date of Event
    November 19, 2012
    Report Date
    December 4, 2012
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    DZJ
    PMA / PMN Number
    K040369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE DEVICE EVAL, THE ROTOR WAS FOUND TO BE STICKING IN THE DRIVESHAFT, AND SEVERAL WORN AND DAMAGED COMPONENTS WERE DISCOVERED, INCLUDING BROKEN DRIVESHAFT BEARINGS. THE FRICTION CAUSED BY WORN OR DAMAGED PARTS IS A PROBABLE CAUSE OF OVERHEATING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN EXTRACTION PROCEDURE AT THE USER FACILITY, THE DRILL WAS OVERHEATING. 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
    1 CORE IMPACTION DRILL DZJ STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK