BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    10NM TORQUE LIMITING RATCHET HANDLE-6MM HXC

    MDR report key: 3072430 · Received April 23, 2013

    Report

    Report Number
    1719045-2013-10849
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    June 19, 2012
    Report Date
    June 19, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    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 THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. 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.(B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PLF AT L3-L4, WHILE THE SURGEON WAS DOING FINAL TIGHTENING, THE SCREWDRIVER HEAD POPPED OFF THE SCREW. AS MORE TORQUE WAS APPLIED TO THE HANDLE, THE TIPS OF THE DRIVERS BECAME DEFORMED, AND WOULD NOT TIGHTEN THE SCREW. NOTHING BROKE INTO THE WOUND, AND NOTHING TO RETRIEVE. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175051 10NM TORQUE LIMITING RATCHET HANDLE-6MM HXC LXH SYNTHES MONUMENT 6596905

    Patients

    Seq Age Sex Outcome Treatment
    1