BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKYLINE CAM TIGHTENER

    MDR report key: 2348915 · Received November 28, 2011

    Report

    Report Number
    1526439-2011-00194
    Event Type
    Malfunction
    Date Received
    November 28, 2011
    Date of Event
    October 13, 2011
    Report Date
    March 8, 2012
    Manufacturer
    DEPUY RAYNHAM
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED AND NO CONCLUSIONS CAN BE MADE. AGE AND CONDITION OF THE DEVICE AT THE TIME OF BREAKAGE IS UNKNOWN. THE CAM TIGHTENER IS USED WITH A TORQUE LIMITING HANDLE THAT IS UNI-DIRECTIONAL AND ONLY LIMITS TORQUE IN A CLOCKWISE DIRECTION (AS SHOWN IN THE SURGICAL TECHNIQUE). USE OF THE DEVICE IN THE OTHER DIRECTION WILL NOT LIMIT TORQUE.

    Additional Manufacturer Narrative · 1

    DEVICE HAS NOT YET BEEN RETURNED TO DEPUY SPINE FOR EVALUATION. A FOLLOW UP REPORT WILL BE SENT WHEN EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    FOLLOW UP REPORT.

    Description of Event or Problem · 1

    RECEIVED MEDWATCH 3500A FORM FROM FDA, REPORTING DEVICE MALFUNCTION. CAM LOCK TIGHTENER OF THE DEPUY SKYLINE PLATING SYSTEM BROKE WHILE IN USE. ALL PIECES WERE ACCOUNTED FOR. THERE WAS NO ADVERSE OUTCOME REPORTED AS A RESULT OF THIS SITUATION. AS THE USER FACILITY REPORTED THE EVENT VIA MEDWATCH, DEPUY SPINE IS FILING A REPORT TO DOCUMENT THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SKYLINE CAM TIGHTENER MANUAL SURGICAL INSTRUMENT LXH DEPUY RAYNHAM

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR