BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTRIC DERMATOME HANDPIECE

    MDR report key: 5095173 · Received September 22, 2015

    Report

    Report Number
    1526350-2015-00164
    Event Type
    Injury
    Date Received
    September 22, 2015
    Date of Event
    August 1, 2015
    Report Date
    November 24, 2015
    Manufacturer
    ZIMMERBIOMET SURGICAL
    Product Code
    GFD
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER; HOWEVER THE INVESTIGATION WAS NOT COMPLETED AT THE TIME OF THIS REPORT. A FOLLOW UP MEDWATCH WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING AMENDED TO REFLECT CHANGES. THIS INFORMATION WAS REPORTED IN ERROR ON INITIAL MDR 1526350-2015-00164 ¿ 1. THE DEVICE WAS MANUFACTURED ON 6/25/1996 AND WAS PREVIOUSLY REPAIRED 7/13/2015 FOR A NON-RELATED ISSUE. INVESTIGATION REVEALED NO ISSUES WITH THE DEVICE. PRIOR TO REPAIR, THE DEVICE OPERATED WITHIN MOTOR SPEED SPECIFICATIONS. THE DEVICE MET CALIBRATION AND SIDE TO SIDE SPECIFICATIONS AT ALL TESTED THICKNESS SETTINGS. REPAIR OF THE DEVICE INCLUDED REPLACEMENT OF THE STANDARD REPAIR PARTS. POST REPAIR ANALYSIS REVEALED THE MOTOR OPERATED WITHIN ELECTRICAL SPECIFICATIONS. THERE WERE NO FUNCTIONAL ISSUES WITH THE POWER SUPPLY, SERIAL NUMBER (B)(4). THE INSULATION OF THE POWER CORD WAS DAMAGED. REPAIR OF THE DEVICE INCLUDED REPLACEMENT OF THE POWER CORD. THE REPORTED EVENT WAS NOT REPRODUCED OR CONFIRMED DURING TESTING AND A CAUSE CANNOT BE DETERMINED. THERE IS NO INFORMATION PROVIDED REGARDING THE USER TECHNIQUE UTILIZED DURING THE REPORTED EVENT; HOWEVER, THE CUSTOMER SHOULD BE AWARE THAT IMPROPER TECHNIQUE CAN POTENTIALLY LEAD TO UNDESIRABLE GRAFTING RESULTS. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE DEVICE WAS SKIPPING WHILE TAKING GRAFTS. ADDITIONAL CLINICAL INFORMATION DETERMINED THAT THE REPORTED ISSUE OCCURRED DURING SURGERY AND A PATIENT WAS INVOLVED IN THE EVENT. IT WAS STATED THAT THERE WAS PATIENT HARM/INJURY AND AN IMPACT/DAMAGE TO GRAFT HARVEST ASSOCIATED WITH THE REPORT. IT WAS CONFIRMED THAT THE INITIAL GRAFT HARVEST WAS UNUSABLE AND AN ADDITIONAL UNPLANNED GRAFT HARVEST WAS REQUIRED FROM THE PATIENT. THE SURGERY WAS COMPLETED USING AN ALTERNATE DEVICE WITH A DELAY OF UNKNOWN DURATION, WHILE THE PATIENT WAS UNDER ANESTHESIA AT THE TIME OF DELAY. NO FURTHER CLINICAL INFORMATION IS INDICATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626170 ELECTRIC DERMATOME HANDPIECE ELECTRIC DERMATOME HANDPIECE GFD ZIMMERBIOMET SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1