BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER ELECTRIC DERMATOME HANDPIECE

    MDR report key: 3023180 · Received February 27, 2013

    Report

    Report Number
    1526350-2013-00099
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 31, 2013
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Removal / Correction Number
    RES 61798
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BEGINNING MAY 31, 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 ELECTRIC 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 IS 14 YEARS OLD AND WAS LAST RETURNED TO THE MANUFACTURER FOR REPAIR ON 03/22/2011. PRIOR TO REPAIR, DAMAGE TO THE HEAD AND CONTROL BAR WERE NOTED AND THE UNIT WAS OUTSIDE CALIBRATION SPECIFICATIONS AT THE ZERO SETTING. INVESTIGATION OF THE UNIT REVEALED THAT THE MOTOR WAS TOO SLOW IN THE INITIAL REVIEW AND TOO FAST DURING THE REPAIR PROCESS; BOTH INSTANCES WERE OUTSIDE OF MOTOR SPECIFICATIONS. SLIGHT CORROSION WAS NOTED ON THE MOTOR DURING POST REPAIR TESTING. CORROSION ON THE MOTOR CASING COULD HAVE CONTRIBUTED TO THE CUSTOMER'S EVENT. 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 ELECTRIC DERMATOME SHOULD BE RETURNED EVERY 12 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 ELECTRIC DERMATOME HAD A PROBLEM CUTTING. DESPITE MULTIPLE FOLLOW UP ATTEMPTS WITH THE CUSTOMER, NO ADDITIONAL INFORMATION WAS ABLE TO BE OBTAINED REGARDING THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84679 ZIMMER ELECTRIC DERMATOME HANDPIECE ZIMMER ELECTRIC DERMATOME HANDPIECE GFD ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1