BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIR DERMATOME HANDPIECE

    MDR report key: 3905244 · Received May 28, 2014

    Report

    Report Number
    1526350-2014-00367
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 2, 2014
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Removal / Correction Number
    RES 61798
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2012, US AND (B)(6) 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 SERVICE RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED ON 11/11/1994 AND WAS LAST REPAIRED ON 10/24/1996 FOR A NON-RELATED ISSUE. INVESTIGATION REVEALED DAMAGE TO THE HEAD, NECK AND HOUSING. THERE WAS ALSO NOTED DAMAGE TO THE SWIVEL AND ECCENTRIC SHAFT. DURING OPERATION THE DEVICE PRODUCED A LOUD NOISE AND THERE WAS ABNORMAL MOVEMENT OF THE RECIPROCATING ARM. PRIOR TO REPAIR, THE DEVICE WAS OUTSIDE CALIBRATION SPECIFICATIONS AT THE 0.0300" THICKNESS SETTING AND SIDE TO SIDE CALIBRATION FAILED AT THE ZERO THICKNESS SETTING. POST REPAIR ANALYSIS REVEALED CORROSION TO THE INTERIOR OF THE HEAD, NECK, HOUSING, SWIVEL, AND RECIPROCATING ARM WAS OBSERVED. IT WAS ALSO NOTED THAT THE E-RINGS OF THE RECIPROCATING ARM AND NEEDLE BEARING WERE MISSING. THE CUSTOMER'S REPORTED EVENT WAS NOT REPRODUCED DURING TESTING; HOWEVER, DUE TO THE LENGTH OF TIME BETWEEN REPAIRS, LACK OF PREVENTATIVE MAINTENANCE MOST LIKELY CAUSED THE MISSING E-RINGS TO THE RECIPROCATING ARM AND NEEDLE BEARING CAUSING THE ABNORMAL MOVEMENT OF THE RECIPROCATING ARM DURING OPERATION, WHICH MOST LIKELY CAUSED THE CUSTOMER'S REPORTED EVENT. THE DEVICE WAS SERVICE AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MOTOR OF THE ZIMMER AIR DERMATOME HANDPIECE WAS RUNNING TOO SLOW. THE CUSTOMER CLARIFIED THAT THE SURGEON FOUND THE DEVICE TO BE RUNNING SLOW PRIOR TO STARTING THE SURGERY. THE SURGEON PROCEEDED WITH A HAND GRAFT AND THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314862 AIR DERMATOME HANDPIECE AIR DERMATOME HANDPIECE GFD ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1