BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIR DERMATOME HANDPIECE

    MDR report key: 2133613 · Received June 16, 2011

    Report

    Report Number
    1526350-2011-00122
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 19, 2011
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR REPAIR. THE SERVICE RECORDS INDICATE THAT THE DEVICE HAS NOT BEEN IN SERVICE SINCE PURCHASED IN 1997. THE INSPECTION FOUND THAT THE DEVICE WAS OUT OF CALIBRATION ON ALL THICKNESS LEVER SETTINGS. THE DEVICE APPEARED TO HAVE NORMAL WEAR AND TEAR. THE LIKELY CAUSE OF THE REPORTED COMPLAINT WAS A FROZEN MOTOR. THIS WOULD BE DUE TO A LACK OF PREVENTATIVE MAINTENANCE. THE CUSTOMER INFORMATION REC'D INDICATED THE DEVICE STARTED WORKING AFTER SOME MINERAL OIL WAS APPLIED TO THE SWIVEL. THIS MAY HAVE MADE ITS WAY TO THE MOTOR, AND TEMPORARILY 'FREED' A STUCK MOTOR. THIS IS A RE-USABLE DEVICE, SUBJECT TO NORMAL WEAR AND TEAR. THIS DEVICE IS 14 YEARS OLD AND HAS NOT PREVIOUSLY BEEN SERVICED AT ZIMMER. THE ZIMMER AIR DERMATOME SHOULD BE RETURNED EVERY 12 MONTHS AND THE HOSE EVERY 6 MONTHS FOR INSPECTION AND PREVENTIVE MAINTENANCE. ANNUAL FACTORY CALIBRATION CHECKS ARE STRONGLY RECOMMENDED TO VERIFY CONTINUED ACCURACY. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN THE BEGINNING OF THE CASE, THE ZIMMER AIR DERMATOME HANDPIECE WOULDN'T ACTIVATE. ADDITIONAL CLINICAL F/U WITH THE HOSPITAL INDICATED THAT THE DEVICE HAD NOT BEEN USED FOR SOME TIME, AND WHEN THEY WENT TO TURN DEVICE ON, IT WAS LIKE IT WAS "FROZE UP", NO SOUND, ONLY THE SOUND OF AIR ESCAPING. THE HOSPITAL ONLY HAD THE ONE DEVICE, THE PT WAS UNDER ANESTHESIA, AND THE DOCTORS WERE TRYING TO FIGURE OUT AN ALTERNATE PLAN FOR COMPLETING THE PROCEDURE. IT WAS SUGGESTED TO PUT SOME MINERAL OIL DIRECTLY IN THE SWIVEL CONNECTOR. AFTER USING THE MINERAL OIL, THE UNIT RAN AND THE PHYSICIAN WAS ABLE TO HARVEST THE PLANNED INITIAL DONOR SITE SUCCESSFULLY. THE LENGTH OF TIME TO DECIDE WHAT TO DO AND/OR HOW TO GET THE DEVICE WORKING WAS ESTIMATED TO BE 1 HOUR OF EXTENDED ANESTHESIA TIME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1