BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAESTRO SMALL STEERING DURAGUA

    MDR report key: 3830606 · Received May 23, 2014

    Report

    Report Number
    0001811755-2014-01892
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Date of Event
    April 29, 2014
    Report Date
    April 29, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HBB
    PMA / PMN Number
    K041754
    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 SERVICE TECHNICIAN THROUGH VISUAL INSPECTION. BASED ON THE RISK DOCUMENTATION A BENT DURAGUARD CAN OCCUR IF EXCESSIVE SIDE LOAD IS APPLIED TO THE FEATURE. DEVICE IS PLACED IN PARTS RETENTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DURAGAURD HAS A BENT FOOT. IT WAS FOUND DURING SERVICE AT THE MANUFACTURER FACILITY. 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
    308388 MAESTRO SMALL STEERING DURAGUA MOTOR, DRILL, PNEUMATIC HBB STRYKER INSTRUMENTS-KALAMAZOO 08299

    Patients

    Seq Age Sex Outcome Treatment
    1