BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.5MM CANNULATED SCREW, FULLY THREADED

    MDR report key: 2945370 · Received February 1, 2013

    Report

    Report Number
    1719045-2013-10001
    Event Type
    Malfunction
    Date Received
    February 1, 2013
    Date of Event
    March 18, 2011
    Report Date
    March 18, 2011
    Manufacturer
    SYNTHES (USA) MONUMENT
    Product Code
    HWC
    PMA / PMN Number
    PRE-AM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE SAMPLE WAS RECEIVED INCOMPLETE. VISUAL INSPECTION OF THE HEAD OF THE SCREW NOTED A BREAKAGE SITE AT THE SECOND THREAD. THE LOT NUMBER IS UNKNOWN THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE COMPLETED. NO CONCLUSION COULD BE DRAWN, AS THE COMPLETE SAMPLE WAS NOT RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TIBIAL PLATEAU FRACTURE PROCEDURE, THE SCREW BROKE UPON INSERTION. THE SHAFT WAS RETRIEVED BY THE DOCTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44955 4.5MM CANNULATED SCREW, FULLY THREADED HWC SYNTHES (USA) MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1