BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIR DERMATOME HANDPIECE

    MDR report key: 4223497 · Received October 29, 2014

    Report

    Report Number
    1526350-2014-00457
    Event Type
    Injury
    Date Received
    October 29, 2014
    Date of Event
    August 1, 2014
    Report Date
    October 9, 2014
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ZIMMER DERMATOME WAS INSPECTED, THE SCREWS/ DEPTH ORIENTATION OF THE BLADE WERE CORRECT, HOWEVER, THE BLADE WAS DISLODGED FROM THE OSCILLATING, BLACK COLORED APPARATUS THAT USUALLY ATTACHES TO THE BLADE. A NEW ZIMMER DERMATOME WAS OPENED AND IN COMPARISON THE APPARATUS MENTIONED WAS VERY LOOSE AND ALL AGREED THAT THE ZIMMER DERMATOME WAS FAULTY. THE LACERATION WAS REPAIRED PRIMARILY (4 INCH LONG AND 5MM WIDE) AND THE NEW ZIMMER USED TO HARVEST THE GRAFT. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO FURTHER ISSUES. IT WAS STATED THAT THERE WAS A DELAY OF FEW MINUTES IN THE SURGERY. THE DEVICE WAS RETURNED TO THE MANUFACTURER; HOWEVER THE INVESTIGATION WAS NOT COMPLETED AT THE TIME OF THIS REPORT. A FOLLOW UP MEDWATCH WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE ZIMMER AIR DERMATOME HANDPIECE HAD AN E CLIP THAT WAS MISSING OFF THE DRIVE SHAFT CAUSING EXCESS MOVEMENT ON THE DRIVE DOG. THE DEVICE WAS REQUIRING SERVICE AND CALIBRATION. ADDITIONAL CLINICAL FOLLOW UP DETERMINED THAT THE ISSUE OCCURRING DURING SURGERY. IN THE REPORTED EVENT THE PATIENT WAS UNDERGOING A DEBRIDEMENT OF A LEFT PRETIBIAL HEMATOMA AND SPLIT THICKNESS SKIN GRAFTING FOR THE WOUND. THE PROCEDURE WAS PROGRESSING NORMALLY. WHEN IT WAS TIME TO HARVEST THE SKIN GRAFT AFTER THE INITIAL DEBRIDEMENT WAS DONE, THE ZIMMER DERMATOME WAS CHECKED AND THE ORIENTATION OF THE BLADE WAS CHECKED, SCREWS WERE TIGHTENED AND GRAFT THICKNESS LEVEL SET TO 10/1000TH OF INCH AS PER NORMAL. IMMEDIATELY UPON HARVESTING THE GRAFT, A CLICK WAS NOTICED AND THE PROCEDURE WAS STOP. A FULL THICKNESS LACERATION ON THE LEFT THIGH WAS NOTED. THE PROCEDURE WAS IMMEDIATELY STOPPED, THE PLASTIC SURGERY CONSULTANT WAS CALLED IN AND THE THEATRE LEAD SISTER WAS CALLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692807 AIR DERMATOME HANDPIECE AIR DERMATOME HANDPIECE GFD ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1