BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTRIC DERMATOME HANDPIECE

    MDR report key: 3190785 · Received June 20, 2013

    Report

    Report Number
    1526350-2013-00325
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 23, 2013
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR REPAIR AND EVALUATION. THE SERVICE RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED ON 01/18/2013 AND HAS NO REPAIR HISTORY AT ZIMMER SURGICAL. EVALUATION OF THE DEVICE OBSERVED THAT THE CONTROL BAR WAS ONLY SLIGHTLY HIGHER THAN THE MASTER BLADE. IT WAS ALSO OBSERVED THAT THE EARS ON THE HEAD OF THE DEVICE WERE GOUGED. PRIOR TO REPAIR, THE DEVICE WAS WITHIN CALIBRATION SPECIFICATIONS. IMPROPER HANDLING MOST LIKELY CAUSED THE MASTER BLADE TO NOT BE FLUSH WITH THE CONTROL BAR. THE CONTROL BAR NOT BEING FLUSH WITH THE MASTER BLADE MOST LIKELY CAUSED THE CUSTOMER'S EVENT. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ZIMMER ELECTRIC DERMATOME WAS DAMAGING GRAFT TISSUE. ADDITIONAL CLINICAL FOLLOW UP WITH THE CUSTOMER INDICATED THAT THE SURGEON USED THE DERMATOME IN A USUAL FASHION. ONCE THE GRAFT WAS OBTAINED THE SURGEON OBSERVED THAT THE GRAFT HAD AN APPEARANCE OF AN INCONSISTENT MESH. DUE TO THIS HE DID NOT PUT THE GRAFT THROUGH THE MESHING PROCESS. THIS LIMITED THE ABILITY TO FULLY COVER THE SITE TO BE GRAFTED. THE SURGEON ALSO OBSERVED THAT THE DERMATOME DID NOT SOUND LIKE IT USUALLY DID. THE SOUND OF THE DEVICE SEEMED TO BE THAT THE CYCLES WERE SLOWER OR ABNORMAL FROM THE USUAL. NO ADDITIONAL UNPLANNED GRAFT HARVEST WAS REQUIRED AS THE SURGEON WAS ABLE TO IMPROVISE AND THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE AS THE ISSUE WAS NOT DISCOVERED UNTIL AFTER THE HARVEST. THERE WAS A 20 MINUTE INCREASE IN PROCEDURE TIME AS THE SURGEON HAD TO BE VERY TEDIOUS IN APPLY THE GRAFT DUE TO THE INCONSISTENCIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280774 ELECTRIC DERMATOME HANDPIECE ELECTRIC DERMATOME HANDPIECE GFD ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1