BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTRIC DERMATOME HANDPIECE

    MDR report key: 3338109 · Received September 5, 2013

    Report

    Report Number
    1526350-2013-00490
    Event Type
    Injury
    Date Received
    September 5, 2013
    Date of Event
    August 1, 2013
    Report Date
    August 6, 2013
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, 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 04/03/1995 AND WAS LAST REPAIRED ON (B)(4) 2013, FOR A NON-RELATED ISSUE. EVALUATION OF THE DEVICE OBSERVED THAT THE 2" AND 3" WIDTH PLATES WERE WORN AND THE DEVICE RAN ERRATICALLY. PRIOR TO REPAIR, THE DEVICE WAS OUTSIDE CALIBRATION SPECIFICATIONS AT THE ZERO THICKNESS SETTING ON THE LEFT AND RIGHT SIDE. AT THE 0.010" AND 0.020" THICKNESS SETTING, THE DEVICE WAS OUTSIDE CALIBRATION SPECIFICATIONS ON THE RIGHT SIDE. THE DEVICE FAILED SIDE TO SIDE CALIBRATION AT ALL THICKNESS SETTINGS. ADDITIONALLY, MINOR EXTERIOR CORROSION WAS OBSERVED ON THE MOTOR. THE CAUSE IS LIKELY THE USER NOT MAINTAINING THE DEVICE PER PROPER HANDLING. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ZIMMER ELECTRIC DERMATOME WAS NOT CUTTING SMOOTHLY. ADDITIONAL CLINICAL FOLLOW UP WITH THE CUSTOMER INDICATED THAT THE PHYSICIAN TRIED USING THE DEVICE AND REPORTED THAT IT WAS BOUNCING AND GOUGING. IT WAS FURTHER REPORTED THAT THE SURGEON STOPPED USING THE DEVICE AND SWITCHED TO USING AN AIR DERMATOME. THERE WAS NO PATIENT INJURY; HOWEVER, THE HARVESTED GRAFT LOOKED UNEVEN FROM THE SKIPPING. ALTHOUGH THE HARVESTED GRAFT WAS ABLE TO BE USED, IT WAS REPORTED THAT IT WAS NOT LARGE ENOUGH TO COVER THE INTENDED AREA AND AN ADDITIONAL, UNPLANNED GRAFT HARVEST WAS REQUIRED. SURGICAL TIME WAS EXTENDED BY APPROXIMATELY 5 MINUTES TO RETRIEVE THE ZIMMER AIR DERMATOME FOR USE TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440296 ELECTRIC DERMATOME HANDPIECE ELECTRIC DERMATOME HANDPIECE GFD ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1