BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIR DERMATOME HANDPIECE

    MDR report key: 3394566 · Received September 18, 2013

    Report

    Report Number
    1526350-2013-00516
    Event Type
    Malfunction
    Date Received
    September 18, 2013
    Date of Event
    August 19, 2013
    Report Date
    August 19, 2013
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    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 03/25/1997 AND WAS LAST REPAIRED ON (B)(4) 2013 FOR A NON-RELATED ISSUE. EVALUATION OF THE DEVICE OBSERVED THAT A REGULATOR WAS ATTACHED TO THE HOSE. INVESTIGATION REVEALED THAT THE HOSE WAS NICKED AND GOUGED AT A LOCALE APPROXIMATELY THREE FEET FROM THE DERMATOME CONNECTOR ON THE HOSE. THE FOREIGN BODY RETURNED WITH THE UNIT WAS NOTED TO MOST LIKELY BE THE SAME MATERIAL AS THE HOSE. PRIOR TO REPAIR, THE DEVICE WAS OUTSIDE CALIBRATION SPECIFICATION AT THE ZERO THICKNESS SETTING ON THE LEFT SIDE. AT THE 0.010" THICKNESS SETTING, THE DEVICE WAS OUTSIDE CALIBRATION SPECIFICATION ON THE LEFT AND RIGHT SIDE. THE DEVICE PASSED SIDE TO SIDE CALIBRATION AT ALL THICKNESS SETTINGS. REPAIR TECHNICIAN REPLACED THE HOSE, CALIBRATING SHAFT AND STANDARD REPAIR PARTS. CUSTOMER DID NOT RETURN ANY ASSOCIATED BLADES FOR INVESTIGATION AND DID NOT REPORT THE THICKNESS SETTING BEING UTILIZED DURING THE EVENT. THE CUSTOMER STATED THAT THE FOREIGN BODY WAS FOUND NEAR THE BLADE. THEREFORE, THE AIR DERMATOME MOST LIKELY CUT THE SUBSTANCE FROM THE LOCALE ON THE HOSE THAT WAS NICKED AND GOUGED. CUSTOMER'S REPORTED EVENT OF SKIPPING COULD NOT BE DUPLICATED; HOWEVER, KNOWN INFORMATION AND INVESTIGATIONAL FINDINGS SUPPORT THE CAUSE OF THE CUSTOMER'S REPORTED EVENT TO MOST LIKELY BE INCORRECT USER TECHNIQUE. IMPROPER HANDLING WAS LIKELY THE CAUSE FOR THE LACK OF CALIBRATION OF THE UNIT. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ZIMMER AIR DERMATOME "SKIPPED." THE DERMATOME WAS TAKEN APART AND A FOREIGN BODY WAS NOTED. ADDITIONAL CLINICAL INFORMATION FROM THE CUSTOMER INDICATED THAT THE HARVESTED GRAFT WAS ACCEPTABLE AND NO ADDITIONAL UNPLANNED GRAFT HARVESTS WERE REQUIRED. CUSTOMER STATED THAT THE FOREIGN BODY WAS PULLED FROM THE AREA OF THE DEVICE WHERE THE BLADE WAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470339 AIR DERMATOME HANDPIECE AIR DERMATOME HANDPIECE GFD ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1