BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIR DERMATOME HANDPIECE

    MDR report key: 2785083 · Received October 10, 2012

    Report

    Report Number
    1526350-2012-00250
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    August 1, 2012
    Report Date
    October 1, 2012
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    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 23 YEARS OLD AND WAS LAST RETURNED TO THE MANUFACTURER FOR REPAIR ON 03/19/1993. UPON ARRIVAL; THE DEVICE DISPLAYED DAMAGE TO THE CONTROL BAR, LEADING EDGE AND THE SLIDE RAIL. THE RECIPROCATING ARM HAD SIGNIFICANT WEAR AND DAMAGE AND THE 2" AND 4" WIDTH PLATES WERE DAMAGED. PRIOR TO REPAIR, DEVICE WAS OUTSIDE OF CALIBRATION SPECIFICATIONS AT ALL 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 INITIALLY REPORTED THAT THE ZIMMER DERMATOME WAS BROKEN. ADDITIONAL CLINICAL FOLLOW UP WITH THE HOSPITAL INDICATED THAT THE UNIT WAS NOT HARVESTING AN EVEN GRAFT, SOME AREAS WERE THICKER THAN OTHERS AND THE DEVICE APPEARED TO BE JUMPING OVER THE SKIN. IT WAS ALSO REPORTED THAT THE HARVESTED TISSUE WAS USABLE AND NO ADDITIONAL DONOR SITE WAS HARVESTED. THERE WAS NO REPORT OF INCREASED SURGICAL TIME OR MEDICAL/SURGICAL INTERVENTION. THIS MEDWATCH IS BEING SUBMITTED AS AN ADVERSE EVENT AS THE REPORTED INDICATED THAT THE HEALING TIME MAY HAVE INCREASED DUE TO DEEPER AREAS OF HARVESTED TISSUE AND THICKER AREAS OF GRAFTED TISSUE EVEN THOUGH NO MEDICAL OR SURGICAL INTERVENTION WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1