BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTRIC DERMATOME KIT

    MDR report key: 3162378 · Received June 6, 2013

    Report

    Report Number
    1526350-2013-00302
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 14, 2013
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Removal / Correction Number
    RES 61798
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    BEGINNING MAY 31, 2012, US AND CANADIAN CUSTOMERS 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. 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 INDICATED THAT THE DEVICE WAS MANUFACTURED ON 10/17/2011 AND HAS NO REPAIR HISTORY AT ZIMMER SURGICAL. EVAL OF THE DEVICE OBSERVED THAT THE CONTROL BAR WAS NICKED. PRIOR TO REPAIR, THE DEVICE WAS WITHIN CALIBRATION SPEC. POST REPAIR FAILURE ANALYSIS DETERMINED THE MOTOR OPERATED OUTSIDE OF SPECS, WHERE IN THE MOTOR WOULD NOT OPERATE AT THE CORRECT SPEED AND DISPLAYED EXCESSIVE AMP DRAW. ADDITIONALLY CORROSION WAS OBSERVED ON THE OUTSIDE OF THE MOTOR CASING. NO INFO WAS OBTAINED REGARDING THE CUSTOMER'S STERILIZATION PRACTICES; HOWEVER, IMPROPER STERILIZATION MOST LIKELY CAUSED THE CORROSION ON THE MOTOR. 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 WAS CUTTING TOO DEEPLY. ADD'L CLINICAL F/U WITH THE REPORTER INDICATED THAT THE ISSUE WAS NOTED DURING TESTING OF THE DEVICE PRIOR TO SURGERY AND WAS NOT USED ON A PT. ANOTHER DERMATOME WAS RETRIEVED FOR USE DURING THE PROCEDURE AND THERE WAS NO DELAY OF THE PROCEDURE STARTING. NO INFO WAS PROVIDED BY THE REPORTER REGARDING HOW THEY DETERMINED THE DEVICE WAS CUTTING TOO DEEPLY PRIOR TO USE. THE CUSTOMER DID NOT PROVIDE DETAILS REGARDING TESTING METHODS THEY PERFORMED TO REACH THIS CONCLUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252587 ELECTRIC DERMATOME KIT ELECTRIC DERMATOME KIT GFD ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1