BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIR DERMATOME HANDPIECE

    MDR report key: 3023176 · Received February 27, 2013

    Report

    Report Number
    1526350-2013-00093
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    January 1, 2013
    Report Date
    December 17, 2012
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR REPAIR AND EVALUATION. THE SERVICE RECORD INDICATES THAT THE DEVICE IS 12 YEARS OLD AND WAS LAST RETURNED TO THE MANUFACTURER FOR REPAIR ON (B)(4) 2007. INVESTIGATION OF THE DEVICE DISPLAYED DAMAGE TO THE HEAD AND CONTROL BAR. TESTING OF THE HOSE REVEALED THAT IT WAS DAMAGED. THE INITIAL INSPECTION ALSO NOTED THAT THE SWIVEL ON THE UNIT SEEMED VERY LOOSE. PRIOR TO REPAIR, THE DEVICE WAS OUTSIDE OF CALIBRATION AT THE ZERO THICKNESS SETTING ON THE LEFT AND RIGHT SIDE. THE DEVICE WAS ALSO OUTSIDE OF CALIBRATION ON THE LEFT SIDE AT THE 0.01 AND 0.02 THICKNESS SETTING. SIDE TO SIDE CALIBRATION WAS OUT AT THE 0, 0.01, 0.02 AND 0.03 THICKNESS SETTINGS. THE CAUSE IS MOST LIKELY DUE TO THE USER NOT MAINTAINING THE DEVICE PER PREVENTIVE MAINTENANCE AND HANDLING ACCORDING TO THE INSTRUCTIONS FOR USE. THE ZIMMER AIR DERMATOME SHOULD BE RETURNED EVERY 12 MONTHS AND THE HOSE EVERY 6 MONTHS FOR INSPECTION AND PREVENTIVE MAINTENANCE. ANNUAL FACTORY CALIBRATION CHECKS ARE STRONGLY RECOMMENDED TO VERIFY CONTINUED ACCURACY. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AIR LEAKED FROM THE HOSE COUPLING AND SWIVEL COUPLING. IT WAS ALSO REPORTED THAT THE ZIMMER DERMATOME ALSO WORKED INTERMITTENTLY. ADDITIONAL CLINICAL FOLLOW UP WITH THE HOSPITAL INDICATED THAT THE REPORTED EVENT OCCURRED DURING STERILE PROCESSING AND THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85119 AIR DERMATOME HANDPIECE AIR DERMATOME HANDPIECE GFD ZIMMER SURGICAL UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1