BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIR DERMATOME HANDPIECE

    MDR report key: 3896034 · Received May 15, 2014

    Report

    Report Number
    1526350-2014-00359
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 15, 2014
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Removal / Correction Number
    RES 61798
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 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 DEVICES AND WARNING THEM OF IMPROPERLY MAINTAINING INSTRUMENTS, WHICH MAY CAUSE DONOR SITE INJURIES OR RESULT IN DAMAGE TO THE GRAFT. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR REPAIR AND EVALUATION. THE SERVICE RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED ON 04/10/2007 AND HAS NO REPAIR HISTORY AT ZIMMER SURGICAL. THE CUSTOMER'S REPORTED EVENT WAS NOT REPRODUCED DURING TESTING OF THE DEVICE AS THE DEVICE OPERATED WITHIN SPECIFICATIONS AND DID NOT EXHIBIT ANY ANOMALOUS BEHAVIOR. EVALUATION DID REVEAL DISCOLORATION AND CORROSION TO THE INTERIOR OF THE DEVICE AND COMPONENTS. PRIOR TO REPAIR, THE DEVICE WAS OUTSIDE CALIBRATION SPECIFICATIONS AT ALL TESTED THICKNESS SETTINGS. REPAIR OF THE DEVICE INCLUDED REPLACEMENT OF THE HEAD, CONTROL BAR, MOTOR SLEEVE, 3 INCH AND 4 INCH WIDTH PLATES, THROTTLE LEVER, CALIBRATING SHAFT, AND STANDARD REPAIR PARTS. THE DEVICE WAS REPAIRED AND SHIPPED TO THE CUSTOMER. A CAUSE OF THE CUSTOMER'S REPORTED EVENT COULD NOT BE DETERMINED; HOWEVER, LACK OF PREVENTATIVE MAINTENANCE OVER THE PAST SEVEN YEARS LIKELY WAS THE CAUSE FOR THE INTERIOR DISCOLORATION AND CORROSION TO THE INTERIOR COMPONENTS, WHICH CAN CONTRIBUTE TO UNDESIRABLE BEHAVIOR OF THE DEVICE DURING OPERATION. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE AIR DERMATOME HANDPIECE WOULD NOT SHUT OFF. THE CUSTOMER STATED THAT THE EVENT HAPPENED DURING SURGERY BUT THERE WAS NO HARM OR INJURY TO THE PATIENT. THE SURGERY WAS COMPLETED WITH ANOTHER DEVICE WITH A VERY MINIMAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290694 AIR DERMATOME HANDPIECE AIR DERMATOME HANDPIECE GFD ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1