BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTRIC DERMATOME HANDPIECE

    MDR report key: 3299812 · Received August 15, 2013

    Report

    Report Number
    1526350-2013-00443
    Event Type
    Injury
    Date Received
    August 15, 2013
    Date of Event
    July 18, 2013
    Report Date
    July 18, 2013
    Manufacturer
    ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS
    Product Code
    GFD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    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 01/06/1997 AND WAS LAST REPAIRED ON 04/18/2013 FOR A NON-RELATED ISSUE. EVAL OF THE DEVICE OBSERVED NO VISIBLE ISSUES WERE OBSERVED. PRIOR TO REPAIR, THE DEVICE WAS OUTSIDE CALIBRATION SPECIFICATION AT THE ZERO THICKNESS SETTING ON THE RIGHT SIDE. 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 WOULD NOT CUT PROPERLY. A NEW SITE WAS THEN PREPPED AND COMPLETED WITH ANOTHER DEVICE. ADD'L CLINICAL FOLLOW UP WITH THE CUSTOMER INDICATED THAT THERE WAS A LACERATION ON THE LEFT LEG WHERE THE DERMATOME DID NOT CUT TO THE PROPER DEPTH. NO SUTURES WERE REQUIRED AND A NEW DONOR SITE WAS USED TO HARVEST A GRAFT WITH A PADGETT DERMATOME. SURGERY TIME WAS EXTENDED BY 20 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394968 ELECTRIC DERMATOME HANDPIECE ELECTRIC DERMATOME HANDPIECE GFD ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR