BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIR DERMATOME HANDPIECE

    MDR report key: 3111169 · Received May 8, 2013

    Report

    Report Number
    1526350-2013-00228
    Event Type
    Injury
    Date Received
    May 8, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 10, 2013
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MFR FOR REPAIR AND EVALUATION. THE SERVICE RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED 02/01/1993 AND WAS LAST REPAIRED ON 08/15/2012. EVALUATION OF THE DEVICE OBSERVED DAMAGE TO THE HEAD AND 2" AND 3" WIDTH PLATES. PRIOR TO REPAIR, THE DEVICE WAS OUTSIDE OF CALIBRATION SPECIFICATIONS AT THE 0.03" THICKNESS SETTING ON THE LEFT SIDE. DAMAGE TO THE HEAD OF THE DEVICE AND LACK OF CALIBRATION MOST LIKELY CAUSED THE CUSTOMER'S EVENT. IMPROPER HANDLING BY THE USER MOST LIKELY CAUSED THE DAMAGE TO THE DEVICE AND THE LACK OF CALIBRATION. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ZIMMER AIR DERMATOME WAS CUTTING THE GRAFT WITH AN UNEVEN THICKNESS. ADDITIONAL CLINICAL FOLLOW UP WITH THE CUSTOMER INDICATED THAT WHILE HARVESTING A SPLIT THICKNESS GRAFT, THE BLADE CUT UNEVENLY AND SHREDDED THE GRAFT. THE GRAFT THAT WAS PRODUCED HAD A SHREDDED APPEARANCE INSTEAD OF UNIFIED THICKNESS AND AS A RESULT, AN ADDITIONAL GRAFT WAS HARVESTED. IT WAS REPORTED THAT ADDITIONAL TIME WAS REQUIRED TO HARVEST THE ADDITIONAL GRAFT; HOWEVER, THE ADDITIONAL AMOUNT OF TIME WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202299 AIR DERMATOME HANDPIECE AIR DERMATOME HANDPIECE GFD ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1