BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE UNIVERSAL DRIVER

    MDR report key: 3192775 · Received June 27, 2013

    Report

    Report Number
    0001811755-2013-01486
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    June 7, 2013
    Report Date
    June 7, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS IN PROGRESS. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION HAS BEEN COMPLETED. INVESTIGATION IS IN PROGRESS. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    UPON DISASSEMBLY FOR VISUAL INSPECTION WIDESPREAD INTERNAL CORROSION WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO THE OPERATING ON THE PATIENT THE CORE UNIVERSAL DRIVER HAD METAL SHAVINGS COMING OUT OF THE DEVICE. NO ADVERSE CONSEQUENCES TO THE USER OR PATIENT WERE REPORTED, AS A RESULT OF THIS EVENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A BACKUP DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO THE OPERATING ON THE PATIENT THE CORE UNIVERSAL DRIVER HAD METAL SHAVINGS COMING OUT OF THE DEVICE. NO ADVERSE CONSEQUENCES TO THE USER OR PATIENT WERE REPORTED, AS A RESULT OF THIS EVENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A BACKUP DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291917 CORE UNIVERSAL DRIVER DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 WIRE COLLET PART NUMBER (B)(4)