BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODMAN CRANIOTOMY KIT

    MDR report key: 3882840 · Received June 19, 2014

    Report

    Report Number
    1226348-2014-11719
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Manufacturer
    CODMAN & SHURTLEFF
    Product Code
    HBF
    PMA / PMN Number
    PK933894
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO GTIN NUMBER AVAILABLE FOR THIS PRODUCT CODE (26-1230). BOTH (2) PERFORATORS INVOLVED IN THIS COMPLAINT WERE RETURNED FOR EVALUATION. THE SUPPLIER EVALUATION WAS RECEIVED ON 8/14/14 AND REVEALED:THE ROOT CAUSE OF "THE PERFORATOR DID NOT DISENGAGE" WAS NOT VERIFIED. A MANUAL OPERATION AND DISENGAGEMENT TEST WAS PERFORMED ON EACH (2) PERFORATOR. THUMB PRESSURE ON THE PERFORATOR POINTS PRODUCED SMOOTH, POSITIVE SPRING ACTIONS, AND ENGAGEMENT OCCURED AS EACH HUDSON WAS ROTATED. IN THE DISENGAGEMENT POSITION, EACH HUDSON ENDS' ROTATION WERE SMOOTH. THE CUSTOMER'S PERFORATORS (2) MET FUNCTIONAL TEST ACCEPTANCE REQUIREMENTS PROPER ENGAGEMENT AND DISENGAGEMENT WAS ACHIEVED WITH EVERY DRILLED HOLE. THE DEVICE HISTORY RECORDS WERE REVIEWED, ALL TESTS AND INSPECTIONS ASSOCIATED WITH THE ASSEMBLY PROCESS MET SPECIFICATION REQUIREMENTS. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED.

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED. COMPLAINT SAMPLE NOT RETURNED.

    Description of Event or Problem · 1

    THE PERFORATOR DID NOT DISENGAGE. RISK OF DURA MATTER PERFORATION AND BRAIN INJURY. (B)(4) 2014 INFORMATION REQUESTED FROM CUSTOMER: THERE ARE TWO PRODUCTS WITH DIFFERENT LOT NUMBERS REPORTED. DID BOTH DEVICES FAIL TO DISENGAGE? CUSTOMER RESPONDED: (B)(6) 2014 YES THEY DID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360280 CODMAN CRANIOTOMY KIT DRILLS, BURRS, TREPHINES & ACCESSORIES HBF CODMAN & SHURTLEFF KF016S

    Patients

    Seq Age Sex Outcome Treatment
    1