BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTRIC DERMATOME HANDPIECE

    MDR report key: 2971726 · Received January 30, 2013

    Report

    Report Number
    1526350-2013-00042
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 7, 2013
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Removal / Correction Number
    RES 61798
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    BEGINNING (B)(4) 2012, (B)(4) CUSTOMER WERE SENT AN URGENT PT 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. CUSTOMER 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 SERVICE RECORD INDICATES THAT THE DEVICE IS 2 YEARS OLD AND WAS LAST RETURNED TO THE MFR FOR REPAIR ON (B)(4) 2011. THE INSPECTION FOUND THAT THE DEVICE WAS OUTSIDE CALIBRATION SPECIFICATIONS AT THE ZERO THICKNESS SETTING ON THE LEFT AND RIGHT SIDE AND THE SIDE TO SIDE. THE DEVICE'S MTOR DID NOT RUN AND DISPLAYED EXCESSIVE CURRENT DRAW DURING POST-REPAIR ANALYSIS. IN POST-REPAIR ANALYSIS, IT WAS ALSO NOTED THAT THE MOTOR ALSO HAD CORROSION ON THE OUTSIDE OF THE CASING. NO INFORMATION WAS OBTAINED REGARDING THE CUSTOMER'S STERILIZATION PRACTICES; HOWEVER, IMPROPER STERILIZATION COULD HAVE CAUSED THE CORROSION ON THE MOTOR. THE CAUSE OF THE REPORTED ISSUE... THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ZIMMER DERMATOME WAS NOT WORKING. ADDITIONAL CLINICAL FOLLOW-UP WITH THE HOSPITAL INDICATED THAT THERE WAS NO INFORMATION AVAILABLE REGARDING THE REPORTED ISSUE. THE FACILITY HAS MULTIPLE ALTERNATE UNITS AVAILABLE AND REPLACEMENT WOULD HAVE OCCURRED WITHOUT DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42000 ELECTRIC DERMATOME HANDPIECE ELECTRIC DERMATOME HANDPIECE GFD ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1