BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTRIC DERMATOME HANDPIECE

    MDR report key: 3252570 · Received July 25, 2013

    Report

    Report Number
    1526350-2013-00398
    Event Type
    Malfunction
    Date Received
    July 25, 2013
    Date of Event
    June 28, 2013
    Report Date
    June 28, 2013
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Removal / Correction Number
    RES 61798
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    BEGINNING 05/31/2012, US AND (B)(6) CUSTOMERS WERE SENT AN URGENT PATIENT SAFETY ADVISORY INFORMING THEM OF THE NEED FOR PROPER CARE AND PREVENTION 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 MFR FOR REPAIR AND EVALUATION. THE SERVICE RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED ON 03/14/2007 AND WAS LAST REPAIRED ON 11/04/2011 FOR A SIMILAR ISSUE. EVALUATION OF THE DEVICE OBSERVED DAMAGE TO THE HEAD, CONTROL BAR AND 2" WIDE PLATE. THE MOTOR WAS DETERMINED TO OPERATE ERRATICALLY. PRIOR TO REPAIR, THE DEVICE WAS OUTSIDE OF CALIBRATION SPECIFICATION AT THE ZERO THICKNESS SETTING ON THE LEFT AND RIGHT SIDES. THE POWER SWITCH, POWER CORD AND STRAIN RELIEF ALL PASSED CONTINUITY TESTING. THE MOTOR DID HOWEVER, DISPLAY CORROSION ON THE OUTSIDE. 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 STARTED AND STOPPED AND DID NOT RUN SMOOTHLY. ADDITIONAL CLINICAL FOLLOW UP WITH THE CUSTOMER INDICATED THAT THE REPORTED ISSUE WAS OBSERVED PRIOR TO SURGERY AND THERE WAS NO PATIENT INVOLVEMENT OR EXTENSION IN SURGICAL TIME. IT WAS REPORTED THAT AN ALTERNATE DEVICE WAS IMMEDIATELY AVAILABLE ONSITE FOR USE DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347717 ELECTRIC DERMATOME HANDPIECE ELECTRIC DERMATOME HADNPIECE GFD ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1