BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIR DERMATOME HANDPIECE

    MDR report key: 3492198 · Received October 25, 2013

    Report

    Report Number
    1526350-2013-00610
    Event Type
    Malfunction
    Date Received
    October 25, 2013
    Date of Event
    September 26, 2013
    Report Date
    September 26, 2013
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MFR FOR REPAIR AND EVAL. THE SERVICE RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED ON 10/10/1990 AND WAS LAST REPAIRED ON (B)(4) 2013 FOR A NON-RELATED ISSUE. EVAL OF THE DEVICE OBSERVED MINOR WEAR AND DISCOLORATION OF THE HANDLE AND WEAR TO THE HEAD AND CONTROL BAR OF THE DEVICE. THE MASTER BLADE WAS FLUSH AND THE DEVICE OPERATED WITHIN SPECIFICATION; HOWEVER, THE DEVICE FALTERED AT TIMES DURING OPERATION. PRIOR TO REPAIR, THE DEVICE WAS WITHIN CALIBRATION SPECIFICATION AT ALL TESTED THICKNESS SETTINGS. IN POST-REPAIR, DISCOLORATION OF THE MOTOR CASING WAS OBSERVED. NO INFO WAS OBTAINED REGARDING CUSTOMER'S STERILIZATION PRACTICES; HOWEVER, IMPROPER STERILIZATION COULD HAVE CAUSED THE EXTERIOR DISCOLORATION OF THE MOTOR. THE CAUSE OF THE DISCOLORATION WAS LIKELY DUE TO THE ENTRY OF MOISTURE WITHIN THE HANDPIECE. THE MOISTURE LIKELY DAMAGED THE MOTOR INTERNALLY, WHICH COULD CAUSE THE CUSTOMER'S REPORTED EVENT. IN ADDITION, IMPROPER HANDLING MOST LIKELY CAUSED THE WEAR TO THE HEAD AND CONTROL BAR OF THE UNIT. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ZIMMER AIR DERMATOME WAS PULSATING. NO ADD'L CLINICAL INFO WAS REC'D PRIOR TO THIS REPORT. A F/U MEDWATCH WILL BE SUBMITTED IF ADD'L CLINICAL INFO IS REC'D.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    550463 AIR DERMATOME HANDPIECE AIR DERMATOME HANDPIECE GFD ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1