BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIR DERMATOME HANDPIECE

    MDR report key: 3394847 · Received September 19, 2013

    Report

    Report Number
    1526350-2013-00521
    Event Type
    Malfunction
    Date Received
    September 19, 2013
    Date of Event
    August 1, 2013
    Report Date
    August 23, 2013
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Removal / Correction Number
    RES 61798
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    BEGINNING ON 05/31/2012, US AND CANADIAN CUSTOMERS WERE SENT AN URGENT PATIENT SAFETY ADVISORY INFORMING THEM OF THE NEED FOR PROPER CARE AND PREVENTIVE MAINTENANCE OF THEIR ZIMMER AIR DERMATOME. CUSTOMERS WERE INFORMED THAT IMPROPERLY MAINTAINED INSTRUMENTS MAY CAUSE DONOR SITE INJURIES OR RESULT IN DAMAGE TO THE GRAFT. CUSTOMERS WERE REQUESTED TO CONTACT ZIMMER TO SCHEDULE MAINTENANCE FOR THE DEVICE IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR REPAIR AND EVALUATION. THE SERVICE RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED ON 10/08/1996 AND WAS LAST REPAIRED ON 07/24/2007 FOR A NON-RELATED ISSUE. EVALUATION OF THE DEVICE OBSERVED DAMAGE TO THE HEAD AND CONTROL BAR AND THE POPPET BECAME STUCK AFTER BEING POWER CYCLED, CAUSING THE UNIT TO OPERATE CONTINUOUSLY. IT WAS ALSO OBSERVED THE THERE WAS CORROSION TO THE POPPET ASSEMBLY, RECIPROCATING ARM, NECK AND HOUSING. PRIOR TO REPAIR, THE DEVICE WAS OUTSIDE CALIBRATION SPECIFICATIONS AT THE ZERO THICKNESS SETTING ON THE LEFT AND RIGHT SIDE. THE DEVICE FAILED SIDE TO SIDE CALIBRATION AT ALL THICKNESS SETTINGS. IN POST-REPAIR, A SMALL PIECE OF CORRODED MATERIAL WAS FOUND TO BE JAMMED BETWEEN THE BOTTOM O-RING OF THE POPPET AND POPPET HOUSING. ONCE THIS MATERIAL WAS REMOVED, THE POPPET MOVED MORE SMOOTHLY. THE CORRODED MATERIAL FOUND BETWEEN THE BOTTOM O-RING OF THE POPPET AND POPPET HOUSING MOST LIKELY CAUSED THE POPPET TO BECOME STUCK, WHICH MOST LIKELY CAUSED THE CUSTOMER'S REPORTED EVENT. LACK OF PREVENTATIVE MAINTENANCE AND IMPROPER HANDLING MOST LIKELY CAUSED THE DAMAGE TO THE UNIT AND LACK OF CALIBRATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ZIMMER AIR DERMATOME WOULD NOT SHUT OFF. ADDITIONAL CLINICAL FOLLOW UP WITH THE CUSTOMER INDICATED THAT THE ISSUE OCCURRED DURING THE SURGERY AFTER THE SURGEON HAD FINISHED HARVESTING A GRAFT. THE SURGEON WAS UNABLE TO GET THE DEVICE TO SHUT OFF AND HAD TO DISCONNECT THE AIR SUPPLY. THERE WAS NO INJURY TO THE PT OR USER, AND AN ALTERNATE DEVICE WAS RETRIEVED TO FINISH THE PROCEDURE. THE SURGICAL TIME WAS EXTENDED BY APPROXIMATELY 5 MINUTES TO RETRIEVE THE ALTERNATE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472283 AIR DERMATOME HANDPIECE AIR DERMATOME HANDPIECE GFD ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1