BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAGITTAL ATTACHMENT

    MDR report key: 2033183 · Received February 28, 2011

    Report

    Report Number
    2033183
    Event Type
    Malfunction
    Date Received
    February 28, 2011
    Date of Event
    January 28, 2011
    Report Date
    February 28, 2011
    Manufacturer
    STRYKER
    Product Code
    GFA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHEN THE STRYKER BATTERY POWERED SAW WAS ACTIVATED, AT THE TIME THE TRIGGER MECHANISM WAS PULLED, INSTRUMENT LUBRICANT AND SMALL DARK PIECES OF MATTER CAME OUT OF THE HEAD OF THE INSTRUMENT. PARTICULATE DEBRIS APPEARS TO BE BITS OF THE RUBBER RING THAT DETERIORATED AND ALLOWED LUBRICANT TO SEEP. THE PATIENT'S WOUND WAS COPIOUSLY IRRIGATED AND WE BELIEVE IT WAS ALL REMOVED. THE PATIENT DID RECEIVE A DOSE OF ANTIBIOTIC IN THE OR. OUR INFECTION PREVENTION DEPARTMENT WAS MADE AWARE AND THEY FELT THERE WAS MINIMAL TO NO RISK OF INFECTION AS THE ITEM WAS AUTOCLAVED PRIOR TO USE. OUR FOLLOW-UP WITH THE PATIENT REPORTS NO APPARENT INJURY AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAGITTAL ATTACHMENT BLADE, SAW, SAGITTAL GFA STRYKER 4100-400 *
    2 DRIVER SURGICAL, ORTHOPEDIC, DRIVER KIJ STRYKER * *

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR