BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE IMPACTION DRILL

    MDR report key: 4121319 · Received September 26, 2014

    Report

    Report Number
    0001811755-2014-03388
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    September 2, 2014
    Report Date
    September 2, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K112593
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE RETURN EXPECTED, BUT NOT YET RECEIVED. A FOLLOW-UP WILL BE SUBMITTED ONCE THE DEVICE IS RECEIVED AND THE QUALITY INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    DURING FAILURE ANALYSIS, THE REPORTED EVENT OF HEAT WAS DUPLICATED AND THE DRIVESHAFT BEARINGS WERE DAMAGED. THE DEVICE CAN EXHIBIT SYMPTOMS OF HEAT IF THE DRIVESHAFT BEARINGS ARE DAMAGED. THEREFORE, IT IS LIKELY THE REPORTED EVENT WAS CAUSED BY THE DAMAGED DRIVESHAFT BEARINGS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CORE IMPACTION DRILL WAS HEATING UP DURING THE COURSE OF A PROCEDURE AT THE USER FACILITY. NO ADVERSE CONSEQUENCES, NO MEDICAL INTERVENTION, AND NO SURGICAL DELAY WERE REPORTED WITH THIS EVENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CORE IMPACTION DRILL WAS HEATING UP DURING THE COURSE OF A PROCEDURE AT THE USER FACILITY. NO ADVERSE CONSEQUENCES, NO MEDICAL INTERVENTION, AND NO SURGICAL DELAY WERE REPORTED WITH THIS EVENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601848 CORE IMPACTION DRILL DRILL, SURGICAL, ENT (ELECTRIC OR PNUMATIC) INCLUDING HANDPIECE ERL STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1