BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIXED DURAGUARD, 16MM

    MDR report key: 3051640 · Received April 10, 2013

    Report

    Report Number
    0001811755-2013-00755
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    March 15, 2013
    Report Date
    March 19, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE DEVICE EVALUATION, IT WAS DETERMINED THAT A PROBABLE CAUSE FOR THE BENT FOOT WAS EXCESSIVE SIDELOAD BEING APPLIED TO THE DEVICE. THE DURA GUARD IS NOT A REPAIRABLE DEVICE AND WILL THEREFORE NOT BE RETURNED TO THE USER FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TESTING CONDUCTED AT THE MANUFACTURER FACILITY, THE FOOT OF THE DURA GUARD WAS FOUND TO BE BENT. NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152203 FIXED DURAGUARD, 16MM DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL STRYKER INSTRUMENTS-KALAMAZOO 12100

    Patients

    Seq Age Sex Outcome Treatment
    1