BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAESTRO MEDIUM FIXED DURAGUARD

    MDR report key: 2042802 · Received March 30, 2011

    Report

    Report Number
    1811755-2011-00977
    Event Type
    Malfunction
    Date Received
    March 30, 2011
    Date of Event
    February 25, 2011
    Report Date
    March 1, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HBB
    PMA / PMN Number
    K041754
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DRILL ATTACHMENT WAS RETURNED TO THE MANUFACTURER AND THE COMPLAINT WAS CONFIRMED. THE DEVICE EVALUATION CONFIRMED THAT THE ARM OF THE DURAGUARD ATTACHMENT HAD BROKEN OFF AT THE BASE. THE CAUSE OF THE BREAKAGE IS UNKNOWN, BUT IS LIKELY DUE TO EXCESSIVE SIDE FORCE BEING APPLIED TO THE DEVICE DURING USE. THE DRILL ATTACHMENT COULD NOT BE REPAIRED AND THEREFORE, WAS NOT RETURNED TO THE USER FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CRANIOTOMY, THE LEG PORTION OF THE DURAGUARD ATTACHMENT BROKE OFF. NO DEVICE FRAGMENTS ENTERED THE SURGICAL SITE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, WITHOUT A DELAY. NO PATIENT OR USER INJURY WAS REPORTED, AND NO OTHER ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAESTRO MEDIUM FIXED DURAGUARD MOTOR, DRILL, PNEUMATIC HBB STRYKER INSTRUMENTS KALAMAZOO 09229

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK