BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIR DERMATOME HANDPIECE

    MDR report key: 3823792 · Received February 20, 2014

    Report

    Report Number
    1526350-2014-00105
    Event Type
    Malfunction
    Date Received
    February 20, 2014
    Date of Event
    January 1, 2014
    Report Date
    January 22, 2014
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    BEGINNING (B)(6) 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 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 EVAL. THE SERVICE RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED ON 08/31/1988 AND WAS LAST REPAIRED ON 07/08/2008 FOR A NON-RELATED ISSUE. EVAL OF THE DEVICE OBSERVED DAMAGE TO THE HEAD, 3" AND 4" WIDTH PLATES. PRIOR TO REPAIR THE DEVICE WAS OUTSIDE CALIBRATION SPECIFICATION AND DID NOT PASS SIDE TO SIDE CALIBRATION CHECK AT THE ZERO THICKNESS SETTING. REPAIR OF THE DEVICE INCLUDED REPLACEMENT OF THE HEAD, 3" AND 4" WIDTH PLATES, AND ALL STANDARD REPAIR PARTS. CUSTOMER DID NOT PROVIDED ANY INFO REGARDING THE POWER SOURCE OR PRESSURE UTILIZED DURING THE REPORTED EVENT. THE DEVICE HAS NOT BEEN IN FOR MAINTENANCE OR REPAIR IN SIX YEARS. THE CUSTOMER'S REPORTED EVENT WAS NOT REPRODUCED DURING EVAL AND CAUSE COULD NOT BE DETERMINED. LACK OF PREVENTATIVE MAINTENANCE LIKELY CAUSED THE LACK OF CALIBRATION AT THE ZERO THICKNESS SETTING AND DAMAGE TO THE HEAD AND 3" AND 4" WIDTH PLATES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PRESSURE WAS NOT REACHING THE MOTOR OR THE MOTOR SEIZED ON THE ZIMMER AIR DERMATOME. NO ADD'L CLINICAL INFO WAS RECEIVED PRIOR TO THIS REPORT. IF ADD'L INFO IS RECEIVED, A F/U MEDWATCH WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106654 AIR DERMATOME HANDPIECE AIR DERMATOME HANDPIECE GFD ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1