BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIR DERMATOME HANDPIECE

    MDR report key: 3426597 · Received October 17, 2013

    Report

    Report Number
    1526350-2013-00582
    Event Type
    Injury
    Date Received
    October 17, 2013
    Date of Event
    September 18, 2013
    Report Date
    September 18, 2013
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Removal / Correction Number
    RES 61798
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BEGINNING MAY 31, 2012, US AND CANADIAN CUSTOMERS WERE SENT AN URGENT PT 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 MFR FOR REPAIR AND EVAL. THE SERVICE RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED ON 09/14/1990 AND WAS LAST REPAIRED ON (B)(4) 2001. EVAL OF THE DEVICE OBSERVED THAT THE DEVICE DID NOT OPERATE. AIR WAS ESCAPING AT THE CONNECTION BETWEEN THE NECK AND HANDLE. DISASSEMBLY OF THE DEVICE REVEALED EXCESSIVE INTERIOR CORROSION. PRIOR TO REPAIR, THE DEVICE WAS OUTSIDE CALIBRATION SPEC ON THE LEFT SIDE AND THE SIDE CALIBRATION AT ALL THICKNESS SETTINGS. LACK OF PREVENTATIVE MAINTENANCE AND IMPROPER HANDLING BY THE CUSTOMER MOST LIKELY CAUSED THE DAMAGE. CORROSION AND LACK OF CALIBRATION OF THE DEVICE. GIVEN THE DAMAGE AND CORROSION TO THE DEVICE, IT IS LIKELY THAT THE MOTOR BECAME DAMAGED, CAUSING THE CUSTOMER'S REPORTED EVENT AS A RESULT. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ZIMMER AIR DERMATOME WAS BOGGING DOWN DURING A CASE. ADD'L CLINICAL F/U WITH THE CUSTOMER INDICATED THAT THE SURGEON HARVESTED PART OF A GRAFT AND THEN THE DEVICE STARTED TO CHEW UP THE GRAFT AND STOPPED WORKING. THE SURGEON WAS ABLE TO USE PART OF THE GRAFT HE HAD HARVESTED, BUT HAD TO TAKE AN ADD'L UNPLANNED GRAFT HARVEST FROM THE PT. AN ALTERNATE DEVICE WAS BORROWED FROM ANOTHER HOSPITAL TO COMPLETE THE PROCEDURE AND SURGERY TIME WAS EXTENDED BY APPROX 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532928 AIR DERMATOME HANDPIECE AIR DERMATOME HANDPIECE GFD ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1