BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIR DERMATOME HANDPIECE

    MDR report key: 3532648 · Received October 30, 2013

    Report

    Report Number
    1526350-2013-00626
    Event Type
    Malfunction
    Date Received
    October 30, 2013
    Date of Event
    September 1, 2013
    Report Date
    September 30, 2013
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Removal / Correction Number
    RES 61798
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    BEGINNING MAY 31, 2012, US AND (B)(6) CUSTOMERS WERE SENT AN URGENT PATIENT SAFETY ADVISORY INFORMING THEM OF THE NEED FOR PROPER CARE AND PREVENTIVE MAINTENANCE OF THEIR ZIMMER AIR DERMATOME. CUSTOMERS WERE INFORMED THAT IMPROPERLY MAINTAINED INSTRUMENTS MAY CAUSE DONOR SITE INJURIES OR RESULT IN DAMAGE TO THE GRAFT. CUSTOMERS WERE REQUESTED TO CONTACT ZIMMER TO SCHEDULE MAINTENANCE FOR THE DEVICE IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR REPAIR AND EVALUATION. THE SERVICE RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED ON 01/10/1992 AND WAS LAST REPAIRED ON 11/22/1996. EVALUATION OF THE DEVICE OBSERVED THAT THE 1" AND 3" WIDTH PLATES WERE OLDER STYLE COMPONENTS, BOTH OF WHICH WERE WORN. ADDITIONALLY, THE THICKNESS CONTROL LEVER AND RECIPROCATING ARM WERE OLDER STYLE COMPONENTS. THE HEAD OF THE DEVICE WAS WORN. THERE WAS ALSO DAMAGE TO THE HEAD AND CONTROL BAR OF THE DEVICE, AS WELL AS TO THE 1" AND 3" WIDTH PLATES. PRIOR TO REPAIR, THE DEVICE WAS OUTSIDE CALIBRATION SPECIFICATIONS AT THE ZERO AND 0.0100" THICKNESS SETTINGS ON THE RIGHT SIDE. THE DEVICE WAS OUTSIDE CALIBRATION SPECIFICATIONS ON THE LEFT AND RIGHT SIDE AT THE 0.0300", AND THE SIDE TO SIDE CALIBRATION SETTING WAS OUT OF SPECIFICATION AT THE ZERO THICKNESS SETTING. LACK OF PREVENTATIVE MAINTENANCE AND IMPROPER HANDLING BY THE USER MOST LIKELY CAUSED THE DAMAGE TO THE HEAD, CONTROL BAR, WIDTH PLATES AND LACK OF CALIBRATION OF THE UNIT, WHICH LIKELY CAUSED THE CUSTOMER'S REPORTED EVENT. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN STATED THAT THE ZIMMER AIRE DERMATOME WAS NOT WORKING CORRECTLY, AND WAS SKIPPING. NO ADDITIONAL CLINICAL INFORMATION WAS RECEIVED PRIOR TO THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    558808 AIR DERMATOME HANDPIECE AIR DERMATOME HANDPIECE GFD ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1