BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTRIC DERMATOME HANDPIECE

    MDR report key: 3943567 · Received April 30, 2014

    Report

    Report Number
    1526350-2014-00338
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    March 1, 2014
    Report Date
    April 16, 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 (B)(4) 1998 AND WAS LAST REPAIRED ON (B)(4) 2003 FOR A NON-RELATED ISSUE. EVALUATION OF THE DEVICE OBSERVED DAMAGE AND EXTENSIVE WEAR TO THE LEADING EDGE OF THE HEAD. THE RECIPROCATING ARM WAS WORN AND SLIGHTLY LOOSE. THE DEVICE DID NOT PERFORM WITHIN MOTOR SPEED SPECIFICATIONS. PRIOR TO REPAIR, THE DEVICE WAS OUTSIDE OF CALIBRATION SPECIFICATION AT THE ZERO THICKNESS SETTINGS. ADDITIONALLY, THE DEVICE FAILED SIDE TO SIDE CALIBRATION AT THE ZERO THICKNESS SETTING. REPAIR OF THE DEVICE INCLUDED REPLACEMENT OF THE HEAD, THE MOTOR, RECIPROCATING ARM AND ALL STANDARD REPAIR PARTS. IN POST-REPAIR ANALYSIS, THE MOTOR INITIALLY DID NOT OPERATE, BUT AFTER MANUAL MANIPULATION OF THE SHAFT, THE MOTOR OPERATED WITHIN ELECTRICAL SPECIFICATIONS UNDER NO LOAD. CORROSION WAS OBSERVED ON THE MOTOR CASING. THE SWITCH PASSED CONTINUITY TESTING. THE DEVICE IS (B)(4) YEARS OLD AND HAS NOT BEEN RETURNED FOR MAINTENANCE OR REPAIR AT ZIMMER SURGICAL IN TEN YEARS; THEREFORE, LACK OF PREVENTATIVE MAINTENANCE LIKELY CAUSED THE DAMAGE TO THE HEAD AND RECIPROCATING ARM, WHICH MOST LIKELY CAUSED THE CUSTOMER'S REPORTED EVENT. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ELECTRIC DERMATOME HANDPIECE HAD DAMAGED TO THE HEAD ASSEMBLY. THERE WAS NO PATIENT HARM OR DELAY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258591 ELECTRIC DERMATOME HANDPIECE ELECTRIC DERMATOME HANDPIECE GFD ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1