BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE IMPACTION DRILL

    MDR report key: 3021775 · Received March 26, 2013

    Report

    Report Number
    0001811755-2013-00606
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 5, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    DZJ
    PMA / PMN Number
    K040369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON DISASSEMBLY FOR VISUAL INSPECTION, IT WAS FOUND THAT THE DRIVESHAFT BEARING WAS DAMAGED.

    Additional Manufacturer Narrative · 1

    DEVICE NOT YET RECEIVED. EVALUATION IS ANTICIPATED UPON RECEIPT OF DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CORE IMPACTION DRILL WAS BEING TESTED AT THE USER FACILITY WHEN TESTING WAS ABORTED DUE TO THE HANDPIECE WOBBLING AND SHAKING. THERE WAS NO PATIENT INVOLVEMENT, AND THERE WERE NO USER INJURIES OR ADVERSE CONSEQUENCES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CORE IMPACTION DRILL WAS BEING TESTED AT THE USER FACILITY WHEN TESTING WAS ABORTED DUE TO THE HANDPIECE WOBBLING AND SHAKING. THERE WAS NO PATIENT INVOLVEMENT, AND THERE WERE NO USER INJURIES OR ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124930 CORE IMPACTION DRILL DRIVER, WIRE, AND BONE DRILL, MANUAL DZJ STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN IMPACTION BUR