BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIR DERMATOME HANDPIECE

    MDR report key: 3227242 · Received July 11, 2013

    Report

    Report Number
    1526350-2013-00366
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 13, 2013
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Removal / Correction Number
    RES 61798
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    BEGINNING (B)(4) 2002, US AND (B)(6) CUSTOMERS WERE SENT AN URGENT PT SAFETY ADVISORY INFORMING THEM OF THE NEED FOR PROPER CARE AND PREVENTIVE MAINTENANCE OF THEIR ZIMMER AIR 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 SVC RECORD INDICATES THAT THE DEVICE WAS MFG ON 07/25/1991 AND HAS NO REPAIR HISTORY AT ZIMMER SURGICAL. EVALUATION OF THE DEVICE OBSERVED THE HEAD TO BE HEAVILY DAMAGED. THE LEADING EDGE WAS GALLED, THE EARS WERE BADLY DENTED AND THE SLIDE RAIL WAS NICKED. THE RECIPROCATING ARM WAS MISSING THE INTERNAL E-RING AND THE CONTROL BAR WAS NICKED. CUSTOMER RETURNED EIGHT WIDTH PLATES, ALL OF WHICH WERE BADLY DAMAGED. PRIOR TO REPAIR THE DEVICE WAS OUT OF SPECIFICATIONS AT EVERY THICKNESS SETTING. 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 AIR DERMATOME SHOULD BE RETURNED EVERY 6 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 AIR DERMATOME WAS TURNING OFF AND ON. ADD'L CLINICAL FOLLOW UP WITH THE CUSTOMER INDICATED THAT THE SURGEON ALSO REPORTED THAT THE DEVICE WAS NOT CUTTING THE CORRECT GRAFT THICKNESS AND THE BLADES WERE CHIPPED. IT WAS REPORTED THAT THE SURGEON WAS ABLE TO USE THE DEVICE TO COMPLETE THE CASE. THERE WAS NO PT HARM OR IMPACT TO THE SURGICAL PROCEDURE AND NO EXTENSION IN SURGICAL TIME OR MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319942 AIR DERMATOME HANDPIECE AIR DERMATOME HANDPIECE GFD ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1