BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODMAN DISPOSABLE PERFORATOR

    MDR report key: 3121769 · Received May 21, 2013

    Report

    Report Number
    1226348-2013-17397
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    April 26, 2013
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    HBF
    PMA / PMN Number
    PK791101
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ROOT CAUSE COULD NOT BE DETERMINED. A FUNCTIONAL TEST COULD NOT BE PERFORMED. THE DRIVE PIN FROM THE PERFORATOR ASSEMBLY WAS NOT RETURNED, AND PERFORMING A FUNCTIONAL TEST ON THIS PERFORATOR WITHOUT THE ORIGINAL PIN COULD PRODUCE A DIFFERENT DRILLING RESULT. THE LOT RECORDS HAVE BEEN REVIEWED AND THEY CONFIRMED THAT THE DEVICE CONFORMED TO THE REQUIRED SPECIFICATIONS PRIOR TO DISTRIBUTION.

    Additional Manufacturer Narrative · 1

    HISTORICALLY FOR COMPLAINTS OF THIS NATURE, THE RETURNED PERFORATORS HAVE BEEN VISUALLY INSPECTED AS RECEIVED, DISASSEMBLED AND CLEANED, AND THEN VISUALLY INSPECTED. NO DISCREPANCIES HAVE BEEN FOUND. THE PERFORATORS HAVE BEEN REASSEMBLED AND WERE FUNCTIONALLY TESTED FOR CUTTING AND DRILLING. THEY¿VE BEEN FOUND TO MEET SPECIFICATION REQUIREMENTS. THE REPORTED CONDITION COULD NOT BE DUPLICATED. REVIEWS OF THE DEVICE HISTORY RECORDS HAVE FOUND NO DISCREPANCIES. THE COMPLAINTS HAVE NOT BEEN CONFIRMED. A FOLLOW UP REPORT WILL BE FILED IF THE INVESTIGATION OF THIS DEVICE REVEALS A RESULT DIFFERENT FROM THAT WHICH IS STATED ABOVE OR IF ANY FURTHER INFORMATION REGARDING THE CAUSE OR MODE OF FAILURE IS MADE AVAILABLE. OTHERWISE, THE COMPLAINT IS CONSIDERED TO BE CLOSED AT THIS TIME.

    Description of Event or Problem · 1

    THE SALES REP REPORTED THAT THE PERFORATOR WAS INVOLVED IN A PLUNGE WITH A PATIENT. NO FURTHER DETAILS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224218 CODMAN DISPOSABLE PERFORATOR DRILLS, BURRS, TREPHINES & ACC HBF CODMAN & SHURTLEFF, INC. ME017S

    Patients

    Seq Age Sex Outcome Treatment
    1