BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTRIC DERMATOME HANDPIECE

    MDR report key: 3358251 · Received August 29, 2013

    Report

    Report Number
    1526350-2013-00480
    Event Type
    Malfunction
    Date Received
    August 29, 2013
    Date of Event
    August 1, 2013
    Report Date
    August 1, 2013
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Removal / Correction Number
    RES 61798
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    BEGINNING MAY 31, 2013, US AND (B)(6) CUSTOMERS WERE SENT AN URGENT PATIENT SAFETY ADVISORY INFORMING THEM OF THE NEED FOR PROPER CARE AND PREVENTIVE MAINTENANCE OF THEIR ZIMMER ELECTRIC 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 INSTRUMENTS FOR USE. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR REPAIR AND EVALUATION. THE SERVICE RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED ON 07/01/1993 AND WAS LAST REPAIRED ON 03/15/2010 FOR A NON-RELATED ISSUE. PRIOR TO REPAIR, THE ELECTRIC DERMATOME DID NOT OPERATE. THE DEVICE WAS OUTSIDE CALIBRATION SPECIFICATION ON THE RIGHT SIDE AT THE ZERO AND 0.010" THICKNESS SETTINGS. THE DEVICE WAS ALSO OUT OF CALIBRATION AT THE ZERO THICKNESS SETTING. THE MASTER BLADE WAS FLUSH. CUSTOMER RETURNED A POWER SUPPLY WITH THE DEVICE AND IT MET FUNCTIONAL SPECIFICATIONS. THE CAUSE IS MOST LIKELY DUE TO THE USER NOT MAINTAINING THE DEVICE PER PREVENTIVE MAINTENANCE AND HANDLING ACCORDING TO THE INSTRUCTIONS FOR USE. THE ZIMMER ELECTRIC DERMATOME SHOULD BE RETURNED EVERY 12 MONTHS FOR INSPECTION AND PREVENTIVE MAINTENANCE. ANNUAL FACTORY CALIBRATION CHECKS ARE STRONGLY RECOMMENDED TO VERIFY CONTINUED ACCURACY. THE DEVICE WAS SERVICED AND RETURNED TO THE CU...

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY THE ZIMMER ELECTRIC DERMATOME DID NOT FUNCTION PROPERLY. ADDITIONAL CLINICAL FOLLOW UP WITH THE CUSTOMER INDICATED THAT THE DEVICE STATED AND THEN STOPPED BEFORE THE PHYSICIAN WAS ABLE TO BEGIN HARVESTING A GRAFT FROM THE PATIENT. THE HOSPITAL DID NOT HAVE AN ALTERNATE DEVICE AVAILABLE FOR USE DURING THE PROCEDURE, SO THE CASE WAS CANCELLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425645 ELECTRIC DERMATOME HANDPIECE ELECTRIC DERMATOME HANDPIECE GFD ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 ZIMMER ELECTRIC DERMATOME POWER SUPPLY:| 00-8821-006-00, SN (B)(4)