BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER AIR DERMATOME II HANDPIECE

    MDR report key: 3223863 · Received July 10, 2013

    Report

    Report Number
    1526350-2013-00360
    Event Type
    Injury
    Date Received
    July 10, 2013
    Date of Event
    June 1, 2013
    Report Date
    June 11, 2013
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MFR FOR REPAIR AND EVAL. THE DEVICE RECORD INDICATED THAT THE DEVICE WAS MANUFACTURED ON 10/26/2012 AND WAS LAST REPAIRED ON (B)(4) 2012, FOR A NON-RELATED ISSUE. EVAL OF THE DEVICE DID NOT OBSERVED ANY DAMAGE. THE DEVICE OPERATED WITHIN SPECS. PRIOR TO REPAIR, THE DEVICE WAS OUT OF CALIBRATION AT EVERY THICKNESS SETTING. THE CAUSE OF THE COMPLAINT WAS MOST LIKELY THE DEVICE BEING OUT OF CALIBRATION. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ZIMMER AIR DERMATOME II PRODUCED AN UNEVEN CUT. ADD'L CLINICAL F/U WITH THE CUSTOMER INDICATED THAT AN ADD'L GRAFT HARVEST WAS REQUIRED AS A RESULT OF THE ISSUE EXPERIENCED WITH THE DEVICE. WHEN THE ISSUE OCCURRED, AN ALTERNATE DEVICE (AIR DERMATOME 00-8801 MODEL) WAS RETRIEVED FOR USE AND THE ADD'L GRAFT WAS HARVESTED WITHOUT ISSUE. THERE WAS A MINIMAL EXTENSION IN SURGICAL TIME, ESTIMATES LESS THAN 5 MINUTES, IN ORDER TO RETRIEVE THE ALTERNATE DERMATOME FOR USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315210 ZIMMER AIR DERMATOME II HANDPIECE ZIMMER AIR DERMATOME II HANDPIECE GFD ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1