BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIR DERMATOME KIT

    MDR report key: 2675824 · Received July 26, 2012

    Report

    Report Number
    1526350-2012-00156
    Event Type
    Malfunction
    Date Received
    July 26, 2012
    Date of Event
    June 1, 2012
    Report Date
    June 29, 2012
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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 THE DEVICE WAS LAST RETURNED TO THE MANUFACTURER FOR MAINTENANCE PRIOR TO 01/1995. THE INSPECTION FOUND THE DEVICE DISPLAYED MULTIPLE DAMAGED COMPONENTS THAT COULD HAVE CONTRIBUTED TO THE EVENT. THE HEAD OF THE UNIT WAS BADLY DAMAGED, WITH NICKS ON THE LEFT END. THE RIGHT EAR HAD A LARGE DENT. THE CONTROL BAR WAS NICKED AND THE THICKNESS CONTROL LEVER WAS VERY LOOSE. THE POWER SWITCH BUTTON WAS MISSING. THE SCREW DRIVER HEAD WAS ALSO STRIPPED. EACH WIDTH PLATE WAS DAMAGED AS WELL. AN ATTEMPT TO RUN THE UNIT PRESENTED A METALLIC CLICKING SOUND AND TEST WAS IMMEDIATELY STOPPED TO NOT FURTHER DAMAGE THE UNIT. THE CAUSE IS MOST LIKELY DUE TO THE USER NOT MAINTAINING THE DEVICE PER PREVENTATIVE MAINTENANCE AND HANDLING ACCORDING TO THE INSTRUCTIONS FOR USE. THIS IS A RE-USABLE DEVICE, SUBJECT TO NORMAL WEAR AND TEAR. ACCORDING TO THE INSTRUCTIONS FOR USE INCLUDED WITH THE DEVICE, 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 DERMATOME PRODUCED A BAD GRAFT, WHICH LOOKED AS IF IT HAD BEEN CHEWED. THERE WERE NO INDICATIONS THAT ANY ADDITIONAL TISSUE HARVEST HAD BEEN NECESSARY. THERE WAS NO REPORT OF ANY HARM OR SURGICAL INTERVENTION RESULTING FROM THE REPORTED EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1