BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE IMPACTION DRILL

    MDR report key: 2853988 · Received October 24, 2012

    Report

    Report Number
    1811755-2012-03891
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Date of Event
    September 4, 2012
    Report Date
    September 25, 2012
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    DZJ
    PMA / PMN Number
    K040369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISASSEMBLED TO BE VISUALLY EXAMINED. DURING THE VISUAL EXAMINATION, THE DEVICE WAS FOUND TO HAVE CORRODED COMPONENTS INCLUDING THE DRIVESHAFT ASSEMBLY, SPINDLE HOUSING, ROTOR, NOSECONE, AND BEARING STOP. BASED ON THE FINDINGS OF THE VISUAL EXAMINATION, THE OBSERVED HEAT WAS MOST LIKELY DUE TO THE CORROSION ON AND AROUND THE DRIVESHAFT ASSEMBLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CORE IMPACTION DRILL HEATED UP DURING A PROCEDURE. A BACK-UP DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT PT OR USER INJURIES, AND THERE WERE NO ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORE IMPACTION DRILL DZJ STRYKER INSTRUMENTS KALAMAZOO 0720708823

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK