BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIR DERMATOME HANDPIECE

    MDR report key: 3850560 · Received May 22, 2014

    Report

    Report Number
    1526350-2014-00363
    Event Type
    Injury
    Date Received
    May 22, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 22, 2014
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Removal / Correction Number
    RES 61798
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    MAY 31, 2012, US AND CANADIAN CUSTOMERS WERE SENT AN URGENT PATIENT SAFETY ADVISORY INFORMING THEM OF THE NEED FOR PROPER CARE AND PREVENTIVE MAINTENANCE OF THEIR DEVICE INFORMING THEM OF IMPROPERLY MAINTAINING INSTRUMENTS THAT MAY CAUSE DONOR SITE INJURIES OR RESULT IN DAMAGE TO THE GRAFT. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR REPAIR AND EVALUATION. THE DEVICE RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED ON 04/15/1994 AND WAS PREVIOUSLY RETURNED FOR REPAIR ON (B)(4) 2012. INVESTIGATION REVEALED THE DEVICE OPERATED WITHIN SPECIFICATION. PRIOR TO REPAIR, THE DEVICE WAS OUTSIDE CALIBRATION SPECIFICATION AT THE ZERO THICKNESS SETTING; HOWEVER THIS WOULD NOT IMPACT GRAFTING ABILITY. REPAIR OF THE DEVICE INCLUDED REPLACEMENT OF THE 4" WIDTH PLATE, SWIVEL AND STANDARD REPAIR PARTS. POST REPAIR ANALYSIS REVEALED DISCOLORATION TO THE SWIVEL. THE CUSTOMER'S REPORTED EVENT WAS NOT REPRODUCED DURING TESTING AND, THEREFORE, A CAUSE CANNOT BE DETERMINED. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ZIMMER AIR DERMATOME HANDPIECE WOULD NOT HARVEST A GOOD GRAFT. THE ISSUE OCCURRED DURING SURGERY. THERE WAS AN IMPACT/DAMAGE TO THE GRAFT HARVEST AND AN ADDITIONAL UNPLANNED GRAFT HARVEST USED AGAIN, RESULTING IN A GOOD GRAFT. NO ALTERNATE DEVICE WAS RETRIEVED. THE SURGERY WAS DELAYED DUE TO TAKING ANOTHER UNPLANNED GRAFT, HOWEVER, THE AMOUNT OF TIME WAS NOT KNOWN. IT WAS REPORTED THAT NO HARM OR INJURY OCCURRED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306919 AIR DERMATOME HANDPIECE AIR DERMATOME HANDPIECE GFD ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1