BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIR DERMATOME HANDPIECE

    MDR report key: 3894504 · Received April 25, 2014

    Report

    Report Number
    1526350-2014-00325
    Event Type
    Malfunction
    Date Received
    April 25, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 1, 2014
    Manufacturer
    ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS
    Product Code
    GFD
    Removal / Correction Number
    REF 61798
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    ON MAY 31, 2012, US AND (B)(6) CUSTOMERS WERE SENT AN URGENT PATIENT SAFETY ADVISORY INFORMING OF THE NEED FOR PROPER CARE AND PREVENTATIVE MAINTENANCE OF THEIR DEVICE INFORMATION THEM OF IMPROPERLY MAINTAINING INSTRUMENTS THAT MAY CAUSE DONOR SITE INJURIES OR RESULTS IN DAMAGE TO THE GRAFT. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR REPAIR AND EVALUATION. THE SERVICE RECORD INDICATES THAT HE DEVICE WAS MANUFACTURED ON MAY 12, 1997 AND WAS LAST REPAIRED ON MAY 20, 2004 FOR A NON-RELATED ISSUE. EVALUATION OF THE DEVICE OBSERVED THE INTERMITTENT OPERATION OF THE DEVICE. THERE WAS ALSO DAMAGE TO THE HEAD AND CONTROL BAR. PRIOR TO REPAIR, THE DEVICE WAS WITHIN CALIBRATION SPECIFICATIONS AT ALL TESTED THICKNESS SETTINGS. REPAIR OF THE DEVICE INCLUDED REPLACEMENT OF THE MOTOR, HEAD, CONTROL BAR, HOUSING AND ALL STANDARD REPAIR PARTS. POST REPAIR ANALYSIS REVEALED DISCOLORATION TO THE MOTOR SLEEVE AND THE MOTOR COULD NOT BE SEPARATED FROM THE MOTOR SLEEVE. IN ADDITION, CORROSION TO THE INTERIOR OF THE HOUSING WAS OBSERVED. THIS DEVICE HAS NOT BEEN RETURNED TO ZIMMER SURGICAL FOR MAINTENANCE OR REPAIR IN TEN YEARS; THEREFORE, LACK OF PREVENTATIVE MAINTENANCE MOST LIKELY CAUSED THE CORROSION WITHIN THE HANDPIECE, 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 AIR DERMATOME HANDPIECE WAS NOT WORKING. IT WAS ALSO MENTIONED THAT, THE MACHINE WAS WORKING INTERMITTENTLY. THERE WAS NO PATIENT HARM OR DELAY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252708 AIR DERMATOME HANDPIECE AIR DERMATOME HANDPIECE GFD ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1