BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIR DERMATOME HANDPIECE

    MDR report key: 5092182 · Received September 21, 2015

    Report

    Report Number
    1526350-2015-00162
    Event Type
    Injury
    Date Received
    September 21, 2015
    Date of Event
    August 1, 2015
    Report Date
    November 25, 2015
    Manufacturer
    ZIMMERBIOMET SURGICAL
    Product Code
    GFD
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER; HOWEVER THE INVESTIGATION WAS NOT COMPLETED AT THE TIME OF THIS REPORT. A FOLLOW UP MEDWATCH WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING AMENDED TO REFLECT CHANGES. THIS INFORMATION WAS REPORTED IN ERROR ON INITIAL MDR 1526350-2015-00162 ¿ 1. THE DEVICE WAS MANUFACTURED ON 6/16/2003 AND HAS NO REPAIR HISTORY AT ZIMMER SURGICAL SINCE JULY 2011. INVESTIGATION REVEALED DAMAGE TO THE HEAD, CONTROL BAR AND HOSE. PRIOR TO REPAIR, THE DEVICE OPERATED WITHIN MOTOR SPEED SPECIFICATIONS AND THE MASTER BLADE WAS FLUSH WITH THE CONTROL BAR. THE DEVICE MET CALIBRATION AND SIDE TO SIDE SPECIFICATIONS AT ALL TESTED THICKNESS SETTINGS. REPAIR OF THE DEVICE INCLUDED REPLACEMENT OF THE HEAD, CONTROL BAR, HOSE AND STANDARD REPAIR PARTS. THE REPORTED EVENT WAS NOT REPRODUCED DURING TESTING AND A CAUSE CANNOT BE DETERMINED. THE CONTROL BAR WAS PROPERLY POSITIONED RELATIVE TO THE BLADE AND THE DEVICE MET CALIBRATION SPECIFICATIONS. THERE IS NO INFORMATION REGARDING THE USER TECHNIQUE UTILIZED DURING THE PROCEDURE; HOWEVER, IMPROPER USER TECHNIQUE CAN LEAD TO UNDESIRABLE GRAFTING RESULTS. IT SHOULD ALSO BE NOTED PER THE INSTRUCTIONS FOR USE, ""THE ZIMMER AIR DERMATOME SHOULD BE RETURNED EVERY 12 MONTHS AND THE HOSE EVERY 6 MONTHS FOR INSPECTION AND PREVENTIVE MAINTENANCE. ANNUAL FACTORY CALIBRATION CHECKS ARE STRONGLY RECOMMENDED TO VERIFY CONTINUED ACCURACY." THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE DEVICE TOOK A CHUNK OUT OF THE PATIENT. NO ADDITIONAL CLINICAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624068 AIR DERMATOME HANDPIECE AIR DERMATOME HANDPIECE GFD ZIMMERBIOMET SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1