BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIR DERMATOME HANDPIECE

    MDR report key: 3177352 · Received June 13, 2013

    Report

    Report Number
    1526350-2013-00319
    Event Type
    Malfunction
    Date Received
    June 13, 2013
    Date of Event
    May 20, 2013
    Report Date
    May 20, 2013
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MFR FOR REPAIR AND EVAL. THE SVC RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED 11/10/1993 AND WAS LAST REPAIRED ON 02/28/2013 FOR A NON-RELATED ISSUE. EXAMINATION OF THE DEVICE OBSERVED THAT THE THICKNESS CONTROL LEVER WAS TIGHT BUT COULD BE MOVED. PRIOR TO REPAIR, THE DEVICE WAS OUTSIDE OF CALIBRATION AT THE ZERO THICKNESS SETTING ON THE LEFT SIDE. THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE THICKNESS CONTROL LEVEL COULD NOT BE TURNED ON THE ZIMMER AIR DERMATOME. ADDITIONAL CLINICAL F/U WITH THE CUSTOMER INDICATED THAT THE ISSUE WAS OBSERVED PRIOR TO THE PROCEDURE AND THERE WAS NO PT INJURY OR MEDICAL INTERVENTION. IT WAS FURTHER REPORTED THAT AN ALTERNATE DEVICE WAS NOT IMMEDIATELY AVAILABLE FOR USE AND THERE WAS A 45 MIN INCREASE / DELAY IN SURGICAL TIME WHILE THE PT WAS UNDER GENERAL ANESTHESIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269056 AIR DERMATOME HANDPIECE AIR DERMATOME HANDPIECE GFD ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1