BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOANER REMB UNIVERSAL DRIVER

    MDR report key: 4221797 · Received November 3, 2014

    Report

    Report Number
    0001811755-2014-03928
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    October 13, 2014
    Report Date
    October 13, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K112593
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS REPAIRED AND PLACED BACK INTO STRYKER STOCK.

    Description of Event or Problem · 1

    THE LOANER REMB UNIVERSAL DRIVER WAS RETURNED TO STRYKER INSTRUMENTS FOR SERVICE. DURING FUNCTIONAL TESTING BY A SERVICE TECHNICIAN, IT WAS FOUND THAT THE DEVICE WAS ABLE TO RUN IN REVERSE WHILE IT WAS IN SAFE MODE. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING AT THE MANUFACTURER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703813 LOANER REMB UNIVERSAL DRIVER DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1