BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER DERMATOME BLADE

    MDR report key: 1880823 · Received October 1, 2010

    Report

    Report Number
    1526350-2010-00125
    Event Type
    Malfunction
    Date Received
    October 1, 2010
    Date of Event
    April 28, 2010
    Report Date
    August 31, 2010
    Manufacturer
    ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS
    Product Code
    GFD
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE HOSPITAL RETURNED THE COMPLAINT SAMPLE AND THE COMPLAINT ISSUE WAS CONFIRMED. THE LEFT RIVET ON THE BLADE HAD AN INCOMPLETE WELD. IT APPEARS THAT WEAK WELD IS THE CAUSE OF THE LOOSE CONTACT BETWEEN THE RIVET AND BLADE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING A ZIMMER DERMATOME BLADE, THE BLADE CUT DEEPER ON ONE SIDE AND THINNER ON THE OTHER WHICH CAUSED IMPAIRED HEALING FROM AN ESTHETICAL POINT OF VIEW. THIS REPORT IS BASED ON A SECOND INCIDENT WITH THE SAME HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER DERMATOME BLADE ZIMMER DERMATOME BLADE GFD ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS NA 61407990

    Patients

    Seq Age Sex Outcome Treatment
    1