BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIR DERMATOME HANDPIECE

    MDR report key: 3779020 · Received April 15, 2014

    Report

    Report Number
    1526350-2014-00266
    Event Type
    Injury
    Date Received
    April 15, 2014
    Date of Event
    March 1, 2014
    Report Date
    March 18, 2014
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Removal / Correction Number
    RES 61798
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    MAY 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 DEVICE INFORMING THEM OF IMPROPERLY MAINTAINING INSTRUMENTS THAT MAY CAUSE DONOR SITE INJURIES OR RESULT IN DAMAGE TO THE GRAFT. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR REPAIR AND EVALUATION. THE SERVICE RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED ON 5/23/1990 AND WAS LAST REPAIRED ON (B)(4) 2012 FOR A NON-RELATED ISSUE. EVALUATION OF THE DEVICE OBSERVED THE MOTOR SPEED SPECIFICATIONS AND THERE WAS NO OBSERVED SKIPPING. THE MOTOR AND THE GEARS WERE VERY DIRTY AND THE HEAD, HOSE AND SCREWDRIVER WERE DAMAGED. PRIOR TO REPAIR, THE DEVICE WAS OUT OF CALIBRATION SPECIFICATIONS ONLY AT THE ZERO THICKNESS SETTING. REPAIR OF THE DEVICE INCLUDED REPLACEMENT OF THE MOTOR, GEARS, HEAD, HOSE, SCREW DRIVER AND STANDARD REPAIR PARTS. IN POST REPAIR ANALYSIS, DISCOLORATION TO THE MOTOR SLEEVE AND CORROSION TO THE RECIPROCATING ARM WAS OBSERVED. THE CUSTOMER'S REPORTED EVENT WAS NOT REPRODUCED DURING TESTING AND A CAUSE CANNOT BE DETERMINED; HOWEVER, THE CORROSION AND DEBRIS OBSERVED TO THE MOTOR AND MOTOR SLEEVE COULD HAVE POTENTIALLY CAUSED THE MOTOR TO MALFUNCTION AND CAUSE THE DEVICE TO SKIP. SPECIAL CARE REGARDING CLEANING AND STERILIZATION SHOULD BE TAKEN IN ORDER TO PREVENT MOISTURE ACCUMULATION WITHIN THE HANDPIECE. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMERS.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE AIR DERMATOME HANDPIECE WAS SKIPPING. THERE WAS NO PATIENT HARM; HOWEVER, THERE WAS A SMALL DELAY IN SURGERY. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE. AN ADD'L UNPLANNED GRAFT WAS TAKEN TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231148 AIR DERMATOME HANDPIECE AIR DERMATOME HANDPIECE GFD ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1