BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTRIC DERMATOME HANDPIECE

    MDR report key: 3890852 · Received June 4, 2014

    Report

    Report Number
    1526350-2014-00373
    Event Type
    Injury
    Date Received
    June 4, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 8, 2014
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    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 01/08/2013 AND WAS PREVIOUSLY RETURNED FOR REPAIR ON (B)(4) 2013 FOR A NON-RELATED ISSUE. INVESTIGATION REVEALED THE DEVICE OPERATED ERRATICALLY. THE POWER SUPPLY FUNCTIONED PROPERLY AND WITHIN SPECIFICATION. PRIOR TO REPAIR, THE DEVICE WAS OUTSIDE CALIBRATION SPECIFICATION AT THE ZERO THICKNESS SETTING. A MOTOR SPEED COULD NOT BE CAPTURED DUE TO THE ERRATIC STATE OF THE DEVICE. REPAIR OF THE DEVICE INCLUDED REPLACEMENT OF THE MOTOR AND STANDARD REPAIR PARTS. POST REPAIR ANALYSIS REVEALED SLIGHT DISCOLORATION AND CORROSION TO THE MOTOR CASING. THE MOTOR OPERATED WITHIN SPECIFICATIONS UNDER NO LOAD. THE CUSTOMER'S REPORTED EVENT WAS NOT REPRODUCED DURING TESTING; HOWEVER, THE ERRATIC OPERATION OF THE DEVICE MOST LIKELY CAUSED THE CUSTOMER'S REPORTED EVENT REGARDING THE DEVICE MAKING "SWISS CHEESE OF THE GRAFT". GIVEN THAT THE MOTOR OPERATED NORMALLY UNDER NO LOAD A SPECIFIC CAUSE FOR THE ERRATIC OPERATION OF THE DEVICE CANNOT BE DETERMINED. SPECIAL CARE, REGARDING CLEANING AND STERILIZATION, SHOULD BE TAKEN IN ORDER TO PREVENT MOISTURE FROM ENTERING AND ACCUMULATING WITHIN THE HANDPIECE. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ZIMMER ELECTRIC DERMATOME HANDPIECE MADE SWISS CHEESE OF THE GRAFT. THE CUSTOMER STATED THAT THE MALFUNCTION DID HAPPEN DURING A SURGERY WHERE THEY WERE ABLE TO USE PART OF THE GRAFT THAT WAS TAKEN, BUT THEY DID NEED TO TAKE AN ADDITIONAL UNPLANNED GRAFT FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327502 ELECTRIC DERMATOME HANDPIECE ELECTRIC DERMATOME HANDPIECE GFD ZIMMER SURGICAL UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1