BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER AIR DERMATOME HANDPIECE

    MDR report key: 3023178 · Received February 27, 2013

    Report

    Report Number
    1526350-2013-00097
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 30, 2013
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Removal / Correction Number
    RES 61798
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    BEGINNING (B)(36) 2012, US AND CANADIAN CUSTOMERS WERE SENT AN URGENT PATIENT SAFETY ADVISORY INFORMING THEM OF THE NEED FOR PROPER CARE AND PREVENTIVE MAINTENANCE OF THEIR ZIMMER AIR DERMATOME. CUSTOMERS WERE INFORMED THAT IMPROPERLY MAINTAINED INSTRUMENTS MAY CAUSE DONOR SITE INJURIES OR RESULT IN DAMAGE TO THE GRAFT. CUSTOMERS WERE REQUESTED TO CONTACT ZIMMER TO SCHEDULE MAINTENANCE FOR THE DEVICE IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR REPAIR AND EVALUATION. THE SERVICE RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED ON 08/20/2007 AND HAS NO PREVIOUS REPAIR HISTORY. THE INSPECTION FOUND DAMAGE TO THE HEAD AND CONTROL BAR OF THE DEVICE. PRIOR TO REPAIR, THE DEVICE WAS OUTSIDE OF CALIBRATION SPECIFICATIONS AT ALL THICKNESS SETTINGS. DURING REPAIR, IT WAS NOTED THAT THE HOSE RETURNED WITH THIS UNIT WAS LEAKING. DURING CLINICAL FOLLOW UP, THE CUSTOMER STATED THE DEVICE WAS UTILIZED AT 150 PSI WITH NO EXTENSION CODE. PER INSTRUCTIONS FOR USE, "RECOMMENDED PRESSURE IS 100 PSI RUNNING, USING SUPPLIED HOSE. 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 THE ZIMMER AIR DERMATOME WAS CUTTING UNEVEN. ADDITIONAL CLINICAL FOLLOW UP WITH THE HOSPITAL INDICATED THAT THE DEVICE WAS UTILIZED AT 150 PSI WITH NO EXTENSION CODE. THERE WAS NO REPORT OF HARM, INJURY, DELAY, INCREASED SURGICAL TIME, OR MEDICAL/SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84992 ZIMMER AIR DERMATOME HANDPIECE ZIMMER AIR DERMATOME HANDPIECE GFD ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1