BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER AIR DERMATOME HANDPIECE

    MDR report key: 3226377 · Received July 11, 2013

    Report

    Report Number
    1526350-2013-00364
    Event Type
    Injury
    Date Received
    July 11, 2013
    Date of Event
    June 1, 2013
    Report Date
    June 12, 2013
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 12/22/1992 AND WAS LAST REPAIRED ON (B)(6) 2012 FOR A NON-RELATED ISSUE. EVALUATION OF THE DEVICE IDENTIFIED A NOISE WHEN THE DEVICE WAS TURNED ON. PRIOR TO REPAIR, THE DEVICE WAS OUTSIDE OF CALIBRATION AT THE ZERO THICKNESS SETTING ON THE LEFT SIDE. DURING REPAIR IT WAS OBSERVED THAT A GEAR WAS BAD. THE MOTOR PREFORMED WITHIN SPECIFICATIONS; HOWEVER, THE BAD GEAR IN THE DEVICE WAS MOST LIKELY THE CAUSE OF THE NOISE IN THE DEVICE. THE DAMAGED GRAFT WAS MOST LIKELY CAUSED BY THE USER NOT MAINTAINING THE DEVICE PER PROPER HANDLING, CAUSING A LACK OF CALIBRATION. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED INITIALLY THAT THE ZIMMER AIR DERMATOME WAS MAKING A NOISE. ADDITIONAL CLINICAL FOLLOW UP WITH THE CUSTOMER INDICATED THAT THE HARVESTED GRAFT WAS DAMAGED. AN ADDITIONAL UNPLANNED GRAFT WAS REQUIRED AND WAS COMPLETED WITH ANOTHER DEVICE. NO FURTHER INFORMATION WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320106 ZIMMER AIR DERMATOME HANDPIECE ZIMMER AIR DERMATOME HANDPIECE GFD ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1