BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIR DERMATOME KIT

    MDR report key: 3347512 · Received August 21, 2013

    Report

    Report Number
    1526350-2013-00460
    Event Type
    Malfunction
    Date Received
    August 21, 2013
    Date of Event
    July 24, 2013
    Report Date
    July 24, 2013
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Removal / Correction Number
    RES 61798
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BEGINNING MAY 31, 2012, U.S. AND CANADIAN 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 MANUFACTURER FOR REPAIR AND EVAL. THE SERVICE RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED 11/22/1994 AND HAS NO REPAIR HISTORY AT ZIMMER SURGICAL. EVAL OF THE DEVICE OBSERVED DAMAGE TO THE HEAD. BOTH THE RECIPROCATING ARM AND INTERIOR OF THE HEAD WERE EXCESSIVELY CORRODED AND DISCOLORED. NICKS WERE ALSO OBSERVED ALONG THE LEADING EDGE OF THE CONTROL BAR AND AN OLD STYLE THICKNESS CONTROL LEVER WAS BEING USED. THE DEVICE OPERATED WITHIN RPM SPECIFICATIONS, BUT MADE A METALLIC NOISE DURING OPERATION. PRIOR TO REPAIR, THE DEVICE WAS OUTSIDE CALIBRATION ON THE RIGHT SIDE AT THE ZERO, 0.02" AND 0.03" THICKNESS SETTINGS. 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 12 MONTHS AND THE HOSE 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 STOPPED WORKING WHEN SLIGHT PRESSURE WAS APPLIED. ADDITIONAL CLINICAL FOLLOW UP WITH THE CUSTOMER INDICATED THAT THE DEVICE STALLED AND THEN SKIPPED WHEN APPLIED TO A PT; THE SURGEON HAD HARVESTED APPROX TWO INCHES WHEN THE DEVICE SKIPPED. IT WAS REPORTED THAT ANOTHER DERMATOME WAS RETRIEVED FOR USE. THERE WAS NO DAMAGE TO THE HARVESTED GRAFT AND THE SURGEON WAS ABLE TO RESUME THE GRAFT HARVEST WHERE THE PAD STOPPED TAKING THE PREVIOUS GRAFT AND CONTINUE THE HARVEST WITH THE REPLACEMENT DERMATOME. THERE WAS NO PT INJURY, OR SURGICAL/MEDICAL INTERVENTION REQUIRED. HOWEVER SURGERY TIME WAS EXTENDED BY 45 MINUTES TO RETRIEVE THE ALTERNATE DERMATOME FOR USE, AS THE HOSPITAL ONLY HAS ONE ALTERNATE ZIMMER DERMATOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405543 AIR DERMATOME KIT AIR DERMATOME GFD ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1