BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE UNIVERSAL DRIVER

    MDR report key: 3113456 · Received May 15, 2013

    Report

    Report Number
    0001811755-2013-01115
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Date of Event
    April 17, 2013
    Report Date
    April 17, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED WHEN THE QUALITY INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT OF AN OUT OF BOX FAILURE OF A REFURBISHED DEVICE WAS NOT DUPLICATED. BASED ON THE OBSERVATIONS DURING THE DEVICE EVALUATION, CONSULTATION WITH A SUBJECT MATTER EXPERT, AND SERIAL NUMBER INQUIRY, STORAGE AND HANDLING OF THE DEVICE AT THE ACCOUNT MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED A REFURBISHED CORDLESS DRIVER. PRIOR TO USE, IT WAS NOTICED THAT THE PAINT WAS CHIPPING ON THE DEVICE. 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 CUSTOMER RECEIVED A REFURBISHED CORDLESS DRIVER. PRIOR TO USE, IT WAS NOTICED THAT THE PAINT WAS CHIPPING ON THE DEVICE. 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
    214084 CORE UNIVERSAL DRIVER DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1