BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI NUT 11MM WIDTH ACROSS FLATS

    MDR report key: 2972354 · Received February 15, 2013

    Report

    Report Number
    2530088-2013-10008
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    April 5, 2011
    Report Date
    April 5, 2011
    Manufacturer
    SYNTHES (USA) BRANDYWINE
    Product Code
    MNH
    PMA / PMN Number
    K992739
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. DHR WAS REVIEWED AND NO ISSUES THAT WOULD HAVE RESULTED IN THIS COMPLAINT WERE FOUND. ALL RELEVANT FEATURES FOR THIS COMPLAINT WERE INSPECTED AND THEY CONFORM TO SPECIFICATIONS; THEREFORE, THIS PRODUCT COMPLAINT IS INVALID.

    Description of Event or Problem · 1

    DURING A SCHEDULED T10 TO ILIUM SURGERY, THE SURGEON REVISED UP TO T2 AND AT THE FINAL TIGHTENING, THE SURGEON WAS TIGHTENING THE TI NUT AT T10. THE TI COLLAR WITH GROOVES OF THE SCREW BROKE. SURGEON RETRIEVED THE BROKEN COLLAR AND NUT. THE SURGEON SELECTED ANOTHER COLLAR AND NUT AND COMPLETED THE PROCEDURE. THERE WAS NO EXTRA TIME AND NO EFFECT TO THE PT. THIS IS 2 OF 2 EVENTS FOR THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69409 TI NUT 11MM WIDTH ACROSS FLATS MNH SYNTHES (USA) BRANDYWINE 6561775

    Patients

    Seq Age Sex Outcome Treatment
    1