BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTRIC DERMATOME HANDPIECE

    MDR report key: 2971236 · Received February 1, 2013

    Report

    Report Number
    1526350-2013-00044
    Event Type
    Malfunction
    Date Received
    February 1, 2013
    Date of Event
    January 10, 2013
    Report Date
    January 4, 2013
    Manufacturer
    ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS
    Product Code
    GFD
    Removal / Correction Number
    RES 61798
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    BEGINNING (B)(4), 2012, US AND (B)(4) CUSTOMERS WERE SENT AN URGENT PATIENT SAFETY ADVISORY INFORMING THEM OF THE NEED FOR PROPER CARE AND PREVENTATIVE 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 EVAL. THE SERVICE RECORD INDICATES THAT THE DEVICE IS 18 YEARS OLD AND WAS LAST RETURNED TO THE MFR FOR REPAIR ON (B)(4) 2009. VERIFICATION OF CALIBRATION DETERMINED THAT THE DEVICE WAS OUTSIDE CALIBRATION AT THE ZERO THICKNESS SETTING ON THE LEFT AND RIGHT SIDE. THE UNIT WAS ALSO OUTSIDE OF SIDE TO SIDE SPECIFICATIONS ON THE ZERO THICKNESS SETTING. THE DEVICE¿S MOTOR DID NOT RUN WHILE INSIDE THE DEVICE, AND DISPLAYED EXCESSIVE CURRENT DRAW DURING POST-REPAIR ANALYSIS. IN POST ¿REPAIR ANALYSIS, IT WAS ALSO NOTED THAT THE MOTOR HAD CORROSION ON THE OUTSIDE OF THE CASING. THE CAUSE IS MOST LIKELY DUE TO THE USER NOT MAINTAINING THE DEVICE PER PREVENTATIVE MAINTENANCE AND HANDLING ACCORDING TO THE INSTRUCTIONS FOR USE. THE ZIMMER ELECTRIC DERMATOME SHOULD BE RETURNED EVERY 12 MONTHS FOR INSPECTION AND PREVENTATIVE 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 MOTOR WAS INTERMITTENTLY LOCKING UP. ADD¿L CLINICAL FOLLOW UP WITH THE HOSPITAL INDICATED THAT THERE WAS NO INFO AVAILABLE REGARDING WHEN THE ISSUE OCCURRED. HOWEVER, THERE WAS NO REPORT OF ANY ADVERSE PATIENT OR PROCEDURE OUTCOME. IT WAS REPORTED THAT ALTERNATE DEVICES ARE AVAILABLE ON SITE FOR USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45376 ELECTRIC DERMATOME HANDPIECE ELECTRIC DERMATOME HANDPIECE GFD ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1