BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER AIR DERMATOME II HANDPIECE

    MDR report key: 2771869 · Received October 2, 2012

    Report

    Report Number
    1526350-2012-00236
    Event Type
    Injury
    Date Received
    October 2, 2012
    Date of Event
    May 9, 2012
    Report Date
    September 6, 2012
    Manufacturer
    ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS
    Product Code
    GFD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MFR FOR REPAIR AND EVAL. THE SERVICE RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED ON 05/04/2012 AND HAS NO REPAIR HISTORY AT ZIMMER SURGICAL. INSPECTION OF THE DEVICE DETERMINED THAT THE LEADING EDGE OF THE HEAD WAS NICKED. A DAMAGED LEADING EDGE OF THE DEVICE COULD HAVE CAUSED THE CUSTOMER¿S EVENT. IMPROPER HANDLING BY THE CUSTOMER MOST LIKELY CAUSED THE DAMAGE. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ZIMMER DERMATOME WAS NOT SLICING PROPERLY AND CUTTING CHUNKS. AT (B)(6) HOSPITAL, THERE HAVE BEEN TWO SURGEONS WHO HAVE USED THE NEW AIR DERMATOME II. IN THREE CASES, THEY HAVE HAD TO TAKE MULTIPLE GRAFTS FROM THE PTS. ADD¿L CLINICAL FOLLOW UP WITH THE HOSPITAL INDICATED THAT THE SURGICAL TIME WAS INCREASED SLIGHTLY DUE TO THE TIME REQUIRED FOR HARVESTING ADDITIONAL TISSUE. INCREASE IN TIME WAS STATED TO BE MINIMAL AND CAUSED NO MEDICAL INTERVENTION. THIS REPORT IS BEING REPORTED ALONG WITH 1526350-2012-00237 AND 1526350-2012-00238.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER AIR DERMATOME II HANDPIECE ZIMMER AIR DERMATOME II HANDPIECE GFD ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1