BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIR DERMATOME HANDPIECE

    MDR report key: 4444817 · Received January 21, 2015

    Report

    Report Number
    1526350-2015-00011
    Event Type
    Injury
    Date Received
    January 21, 2015
    Date of Event
    December 1, 2014
    Report Date
    December 23, 2014
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Removal / Correction Number
    RES 61798
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) 2012, US AND (B)(6) CUSTOMERS WERE SENT AN URGENT PT SAFETY ADVISORY INFORMING THEM OF THE NEED FOR PROPER CARE AND PREVENTIVE MAINTENANCE OF THEIR DEVICE INFORMING THEM OF IMPROPERLY MAINTAINING INSTRUMENTS THAT MAY CAUSE DONOR SITE INJURIES OR RESULT IN DAMAGE TO THE GRAFT. DEVICE WAS MANUFACTURED ON 08/16/1993 AND WAS PREVIOUSLY REPAIRED (B)(4) 2013 FOR A NON-RELATED ISSUE. INVESTIGATION REVEALED THE AIR HOSE WAS DAMAGED. ALL OTHER OBSERVATIONS WERE DEEMED MINOR. PRIOR TO REPAIR, THE DEVICE WAS OUTSIDE CALIBRATION SPECS AT THE ZERO AND 0.0100" THICKNESS SETTINGS. THE DEVICE OPERATED WITHIN MOTOR SPEED SPECS AND THE MASTER BLADE WAS FLUSH WITH THE CONTROL BAR. REPAIR OF THE DEVICE INCLUDED REPLACEMENT OF THE AIR HOSE AND STANDARD REPAIR PARTS. THE CUSTOMER'S REPORTED EVENT WAS NOT REPRODUCED DURING TESTING AND A CAUSE CANNOT BE DETERMINED. THERE IS NO INFO REGARDING THE TECHNIQUE, METHODS, OR WHAT THICKNESS SETTING WAS UTILIZED BY THE USER DURING THE REPORTED EVENT; HOWEVER, INCORRECT USER TECHNIQUE COULD HAVE CAUSED TO PRODUCE VARIABLE THICKNESS WITHIN THE GRAFT. THE AMOUNT AT WHICH THE DEVICE WAS OUTSIDE CALIBRATION SPECS AT THE 010100" THICKNESS SETTING WOULD NOT CAUSE SUCH VARIABLE THICKNESS TO THE GRAFT AND IS NEGLIGIBLE. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE ZIMMER AIR DERMATOME HANDPIECE WAS CUTTING THE TISSUE WITH VARIABLE THICKNESS AND NEEDED TO BE CALIBRATED. ADD'L CLINICAL INFO DETERMINED THAT THE ISSUE OCCURRED DURING SURGERY WHILE THE TISSUE WAS BEING HARVESTED. THERE WAS A PT INVOLVEMENT WITH THE REPORT AND THE PT GRAFT HARVEST SITE HAND TO BE EXTENDED FOR ADD'L TISSUE. THE INITIAL DRAFT HARVEST WAS DAMAGED AND WAS IRREGULAR AND ONLY PARTIALLY USABLE. THE USABLE PORTION OF THE INITIAL GRAFT WAS USED AND AN UNPLANNED ADD'L GRAFT WAS HARVESTED TO COMPLETE THE SURGERY USING AN ALTERNATE DEVICE. THERE WAS A MINOR DELAY OF AROUND 20 MINUTES TO THE PROCEDURE WHILE THE PT WAS UNDER ANESTHESIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49784 AIR DERMATOME HANDPIECE AIR DERMATOME HANDPIECE GFD ZIMMER SURGICAL NA

    Patients

    Seq Age Sex Outcome Treatment
    1