BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIR DERMATOME HANDPIECE

    MDR report key: 3162353 · Received June 6, 2013

    Report

    Report Number
    1526350-2013-00301
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 13, 2013
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Removal / Correction Number
    RES 61798
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    BEGINNING (B)(6) 2012, 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 EVAL. THE SERVICE RECORD INDICATED THAT THE DEVICE WAS MANUFACTURED 09/25/1991 AND WAS LAST REPAIRED ON (B)(6) 2002 FOR A NON-RELATED ISSUE. OBSERVATION OF THE AIR SWIVEL IDENTIFIED EXTERNAL SURFACE SCRATCHES. THE CUSTOMER'S HOSE WAS NOT RETURNED WITH THE DEVICE. HOWEVER, THE CUSTOMER STATED THAT THEY TIRED OTHER HOSES AND NONE OF THEM FIT THE DEVICE WITHOUT PROBLEM. THE COMPLAINT COULD NOT BE DUPLICATED. PRIOR TO REPAIR, THE DEVICE WAS OUTSIDE OF CALIBRATION OF THE ZERO THICKNESS SETTING ON THE RIGHT SIDE. THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE AIR HOSE WOULD NOT CONNECT TO THE ZIMMER AIR DERMATOME AND THE DEVICE COULD NOT BE USED. IT WAS FURTHER REPORTED THAT MULTIPLE AIR HOSES WERE USED AND NONE FIT THE DEVICE. THERE WAS NO PT INJURY AND AN ADD'L DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. IT WAS REPORTED THAT THERE WAS A DELAY OF "A FEW MINUTES" IN ORDER TO OBTAIN THE SECOND DEVICE TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252177 AIR DERMATOME HANDPIECE AIR DERMATOME HANDPIECE GFD ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1