BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.0MM TI CERV SELF-RETAIN SCREW

    MDR report key: 3001810 · Received February 11, 2013

    Report

    Report Number
    8030965-2013-10093
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    March 16, 2011
    Report Date
    March 16, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    KWQ
    PMA / PMN Number
    K071667
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    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 THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MANUFACTURING RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER. AN INVESTIGATION COULD NOT BE COMPLETED. NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    DURING A PROCEDURE, THE SURGEON WAS INSERTING A 4.0 MM TI CERV SELF-RETAINING, SELF-DRILLING SCREW WITH THE EXTRACTION SCREWDRIVER AND THE INNER SHAFT FOR EXTRACTION SCREWDRIVER'S TIP BROKE OFF IN THE HEAD OF THE SCREW. SURGEON REMOVED THE SCREW, SELECTED ANOTHER AND COMPLETED THE PROCEDURE. NO ADDITIONAL TIME WAS ADDED TO THE PROCEDURE. THIS COMPLAINT IS ON THE SCREW. THIS IS REPORT 2 OF 2 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60099 4.0MM TI CERV SELF-RETAIN SCREW KWQ SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR