BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTRIC DERMATOME HANDPIECE

    MDR report key: 3030876 · Received March 28, 2013

    Report

    Report Number
    1526350-2013-00156
    Event Type
    Malfunction
    Date Received
    March 28, 2013
    Date of Event
    February 11, 2013
    Report Date
    March 12, 2013
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Removal / Correction Number
    RES 61798
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    BEGINNING 05/31/2012, US AND (B)(4) CUSTOMERS WERE SENT AN URGENT PT SAFETY ADVISORY INFORMING THEM OF THE NEED FOR PROPER CARE AND PREVENTIVE MAINTENANCE OF THE ZIMMER ELECTRIC DERMATOME. CUSTOMER WERE INFORMED THAT IMPROPERLY MAINTAINED INSTRUMENTS MAY CAUSE DONOR SITE INJURIES OR RESULT IN DAMAGE OF 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 EVAL. THE SVC RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED ON 11/09/2007 AND HAS NO REPAIR HISTORY AT ZIMMER SURGICAL. EVAL OF THE DEVICE DETERMINED THAT THE CONTROL BAR AND HEAD OF THE UNIT WERE NICKED. TESTING OF THE DEVICE DETERMINED THAT THE MOTOR RAN IN AN ERRATIC FASHION. PRIOR TO REPAIR, THE ZERO THICKNESS SETTING WAS OUTSIDE CALIBRATION SPECIFICATIONS ON THE LEFT AND RIGHT SIDE. DURING REPAIR IT WAS OBSERVED THAT THE HOUSING WAS DENTED INWARD, MAKING IT DIFFICULT TO REMOVE THE MOTOR. IT WAS ALSO OBSERVED THAT THE MOTOR WAS CORRODED AND THE INTERNAL WIRING HAD BEEN CHANGED. THE SWITCH AND THE CORD IN THE UNIT HAD BEEN CHARGED AND WERE NOT ZIMMER PARTS. THE CAUSE IS MOST LIKELY DUE TO THE USER NOT MAINTAINING THE DEVICE PER PREVENTIVE MAINTENANCE AND HANDLING ACCORDING TO THE INSTRUCTIONS FOR USE. 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 WAS BROKEN. THROUGH F/U WITH THE HOSPITAL, IT WAS REPORTED THAT NO ADDITIONAL INFO WAS AVAILABLE REGARDING THE REPORTED EVENT. HOWEVER, IT WAS REPORTED THAT THERE WAS NO PT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129543 ELECTRIC DERMATOME HANDPIECE ELECTRIC DERMATOME HANDPIECE GFD ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1