BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEERING DURAGUARD, 16MM

    MDR report key: 3853091 · Received June 6, 2014

    Report

    Report Number
    0001811755-2014-02070
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    May 10, 2014
    Report Date
    May 10, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT OF A BENT FOOT ON THE DURAGUARD WAS CONFIRMED BY A STRYKER DIAGNOSTIC TECHNICIAN THROUGH VISUAL INSPECTION. BASED ON THE RISK DOCUMENTATION A BENT DURAGUARD CAN OCCUR IF EXCESSIVE SIDE LOAD IS APPLIED TO THE FEATURE. DEVICE WAS PLACED IN PARTS RETENTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING ROUTINE MAINTENANCE CONDUCTED BY A MANUFACTURER FIELD SERVICE TECHNICIAN AT THE USER FACILITY THE DURAGAURD WAS BENT. IT WAS REPORTED THAT THERE WAS NO ASSOCIATED PROCEDURE. NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332998 STEERING DURAGUARD, 16MM DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL STRYKER INSTRUMENTS-KALAMAZOO 08086

    Patients

    Seq Age Sex Outcome Treatment
    1