BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL 34 MM AO ATTACHMENT

    MDR report key: 795697 · Received November 30, 2006

    Report

    Report Number
    9615741-2006-00030
    Event Type
    Malfunction
    Date Received
    November 30, 2006
    Report Date
    November 30, 2006
    Manufacturer
    NEWDEAL S.A.
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON INSPECTION OF THE PROUDCT, THE DETERMINATION WAS MADE THAT THE DEVICE DID COMPLIED WITH THE MANUFACTURING SPECIFICATIONS. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO REPORT OF ANOMALIES COULD BE FOUND ON THE MANUFACTURING DATA. NO OTHER COMPLAINTS OF THIS TYPE HAVE BEEN ISSUED ON THIS LOT NUMBER. A DESIGN ERROR HAD OCCURRED. A CHANGE REQUESTED TO LENGTHEN THE DRILL BIT WAS OPENED PRIOR TO THIS INCIDENT.

    Description of Event or Problem · 1

    THE PHYSICIAN INTENDED TO SET A UNI-CLIP STAPLE. DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO DRILL DEEP ENOUGH. THE BIT WAS ONLY 5M LONGER THAN THE GUIDE. THE SURGEON USED A DIFFERENT PRODUCT TO COMPLETE THE PROCEDURE. THIS INCIDENT IS RELATED TO MDR REPORT 961541-2006-00031.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRILL 34 MM AO ATTACHMENT NEWDEAL DRILLS HTW NEWDEAL S.A. * E14L

    Patients

    Seq Age Sex Outcome Treatment
    1 *