BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIR DERMATOME HANDPIECE

    MDR report key: 4002562 · Received June 10, 2014

    Report

    Report Number
    1526350-2014-00374
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    April 1, 2014
    Report Date
    May 15, 2014
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO (B)(4) FOR EVALUATION AND REPAIR. IT WS NOTED THAT THE DEVICE EXHIBITED ANOMALOUS BEHAVIOR DURING OPERATION AND THAT THE MOTOR WAS AGED AND DIRTY. PRIOR TO REPAIR, THE DEVICE INCLUDED REPLACEMENT OF THE MOTOR, MOTOR SLEEVE, BEARINGS, O-RINGS, AND SEMI-CIRCLE. THE DEVICE HAS NOT BEEN RETURNED FOR SERVICING IN SIX YEARS. LACK OF PREVENTATIVE MAINTENANCE LIKELY CAUSED THE MOTOR TO BECOME WORN OVER TIME, RESULTING IN SLOW OPERATION AND THE HARVEST OF A SUB-OPTIMAL GRAFT. PER INSTRUCTIONS FOR USE, "THE ZIMMER AIR DERMATOME SHOULD BE RETURNED EVERY 12 MONTHS AND THE HOSE EVERY 6 MONTHS FOR INSPECTION AND PREVENTATIVE 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 THE ZIMMER AIR DERMATOME HANDPIECE HAD LESS POWER AND WAS NOT ABLE TO BE USED CORRECTLY DURING A SURGERY. THERE WAS NO PATIENT HARM AND THE SURGERY WAS EXTENDED BETWEEN 0-15 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337026 AIR DERMATOME HANDPIECE AIR DERMATOME HANDPIECE GFA ZIMMER SURGICAL UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1