BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIR DERMATOME HANDPIECE

    MDR report key: 3871237 · Received April 16, 2014

    Report

    Report Number
    1526350-2014-00288
    Event Type
    Malfunction
    Date Received
    April 16, 2014
    Date of Event
    February 1, 2014
    Report Date
    April 2, 2014
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR REPAIR AND EVALUATION. THE SERVICE RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED ON 06/01/1995 AND WAS LAST REPAIRED ON 09/04/2012 FOR A NON-RELATED ISSUE. EVALUATION OF THE DEVICE OBSERVED THE RECIPROCATING ARM WAS ABLE TO BE MANUALLY MANIPULATED LATERALLY. DURING OPERATION, THE RECIPROCATING ARM WAS SLIGHTLY ERRATIC AND MADE A METALLIC NOISE. ALSO, THE RETAINING RING WAS MISSING FROM THE NEEDLE BEARING, MAKING IT LOOSE INSIDE THE DEVICE. PRIOR TO REPAIR, THE DEVICE WAS WITHIN CALIBRATION SPECIFICATIONS AT ALL TESTED THICKNESS SETTINGS. REPAIR OF THIS DEVICE INCLUDED REPLACEMENT OF THE HEAD, CONTROL BAR, THICKNESS CONTROL LEVER, SWIVEL, MOTOR, RECIPROCATING ARM,NECK, HOSE, ALL FOUR WIDTH PLATES, NEEDLE BEARING, RETAINING RING AND THE STANDARD REPAIR PARTS. IN POST-REPAIR ANALYSIS, CORROSION TO THE MOTOR SLEEVE, RECIPROCATING ARM AND HEAD WAS OBSERVED. THE CAUSE WAS LIKELY THE USER NOT MAINTAINING THE DEVICE PER PREVENTATIVE MAINTENANCE AND IMPROPER HANDLING AS EVIDENCE BY THE EXTENSIVE DAMAGE AND MISSING COMPONENT OF THE DEVICE. THE SPECIFIC DAMAGES THAT LIKELY CAUSED THE REPORTED EVENT WERE TO THE FOUR WIDTH PLATES AND THE RECIPROCATING ARM, DESCRIBED AS "THE BLACK BLADE ATTACHMENT" DURING CLINICAL FOLLOW UP WITH THE CUSTOMER. THE FUNCTION OF THE RECIPROCATING ARM WAS ALSO LIKELY AFFECTED BY THE LOOSE NEEDLE BEARING MISSING A RETAINING RING ON THE HEAD OF THE DEVICE. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE AIR DERMATOME HANDPIECE WAS NOISY, THE 3 INCH WIDTH PLATE WAS WORN, THE BLACK BLADE ATTACHMENT WAS WOBBLY AND NOT STABLE. THERE WAS NO PT HARM OR DELAY REPORTED, AND THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233587 AIR DERMATOME HANDPIECE AIR DERMATOME HANDPIECE GFD ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1