BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTRIC DERMATOME HANDPIECE

    MDR report key: 3943566 · Received April 30, 2014

    Report

    Report Number
    1526350-2014-00344
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 25, 2014
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 07/30/1997 AND HAS NO REPAIR HISTORY AT ZIMMER SURGICAL. EVALUATION OF THE DEVICE OBSERVED DAMAGE TO THE MACHINE HEAD AND TO BE NON-FUNCTIONAL DURING EVALUATION. ADDITIONALLY, THE CONTROL BAR WAS OBSERVED TO BE NICKED AND THE POWER CORD WAS WORN. PRIOR TO REPAIR, THE DEVICE WAS OUTSIDE OF CALIBRATION SPECIFICATION ONLY AT THE ZERO THICKNESS SETTING ON THE RIGHT SIDE, AND FAILED SIDE TO SIDE CALIBRATION AT THE ZERO THICKNESS SETTING. REPAIR OF THE DEVICE INCLUDED REPLACEMENT OF THE HEAD, MOTOR, POWER CORD, POWER SWITCH, CONTROL BAR, AND STANDARD REPAIR PARTS. THE DEVICE WAS REPAIRED AND SHIPPED TO ZIMMER (B)(6). GIVEN THE EXCESSIVE CORROSION ON THE MOTOR CASING, IT IS LIKELY THAT THE INTERIOR OF THE MOTOR BECAME DAMAGED OVER TIME, WHICH MOST LIKELY CAUSED THE CUSTOMER'S REPORTED EVENT. LACK OF PREVENTATIVE MAINTENANCE MOST LIKELY ALLOWED THE DAMAGE TO THER MOTOR TO OCCUR OVER TIME. THE CAUSE OF THE CORROSION WAS LIKELY DUE TO THE ENTRY OF MOISTURE WITHIN THE HANDPIECE. SPECIAL CARE RELATED TO CLEANING OR STERILIZATION SHOULD BE TAKEN IN ORDER TO PREVENT MOISTURE FROM ENTERING THE HANDPIECE. NO INFORMATION WAS OBTAINED REGARDING CUSTOMER'S CLEANING OR STERILIZATION PRACTICES; HOWEVER, IMPROPER CLEANING OR STERILIZATION COULD HAVE CAUSED THE CORROSION ON THE MOTOR. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ELECTRIC DERMATOME HANDPIECE DID NOT WORK, IT HAD DAMAGED TO THE HEAD ASSEMBLY. THERE WAS NO PATIENT HARM OR DELAY REPORTED, AND THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258553 ELECTRIC DERMATOME HANDPIECE ELECTRIC DERMATOME HANDPIECE GFD ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1