BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIR DERMATOME HANDPIECE

    MDR report key: 3812641 · Received May 6, 2014

    Report

    Report Number
    1526350-2014-00347
    Event Type
    Injury
    Date Received
    May 6, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 11, 2014
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MFR FOR REPAIR AND EVALUATION. THE SERVICE RECORD INDICATES THAT THE DEVICE WAS MFG ON 07/31/1991 AND WAS PREVIOUSLY RETURNED FOR REPAIR ON 10/11/2010. THE CUSTOMER'S REPORTED EVENT WAS NOT REPRODUCED DURING TESTING AS THE DEVICE OPERATED WITHIN SPECIFICATION AND NO ANOMALOUS BEHAVIOR WAS OBSERVED; HOWEVER, DAMAGE TO THE HEAD WAS OBSERVED. PRIOR TO REPAIR, THE DEVICE WAS OUTSIDE CALIBRATION SPECIFICATIONS ONLY AT THE ZERO THICKNESS SETTING. REPAIR OF THE DEVICE INCLUDED REPLACEMENT OF THE HEAD, CONTROL BAR, CAMS, AND STANDARD REPAIR PARTS. A CAUSE OF THE CUSTOMER'S REPORTED EVENT COULD NOT BE DETERMINED. THE THICKNESS SETTING UTILIZED DURING THE REPORTED EVENT IS UNKNOWN AND THE CUSTOMER DID NOT RETURN ANY ASSOCIATED BLADES WITH THE UNIT. ADDITIONALLY, NO INFO IS KNOWN REGARDING THE TECHNIQUE OR METHODS UTILIZED BY THE USER DURING THE REPORTED EVENT, HOWEVER, APPLYING EXCESSIVE DOWNWARD PRESSURE WHILE TAKING THE GRAFT CAN CAUSE THE DERMATOME TO TAKE A GRAFT WHICH IS THICKER THAN DESIRED AND POSSIBLY GOUGE THE PT. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE AIR DERMATOME HANDPIECE TOOK A CHUNK OUT OF A PT EVEN THOUGH THE SKIN SETTING WAS SET LOW. THE REPORTED ISSUE OCCURRED DURING SURGERY WHEREIN THE DEVICE TOOK A CHUNK OUT OF PT AND ADDITIONAL SURGERY WAS REQUIRED TO GIVE STITCHES TO THE PT. AN ALTERNATE DEVICE WAS RETRIEVED TO COMPLETE THE SURGERY AND THERE WAS AN EXTENSION TO THE SURGERY OF UNK LENGTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271162 AIR DERMATOME HANDPIECE AIR DERMATOME HANDPIECE GFD ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1