BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BUTTRESS/ COMPRESSION NUT FOR 357.369

    MDR report key: 2717058 · Received August 22, 2012

    Report

    Report Number
    1719045-2012-00897
    Event Type
    Malfunction
    Date Received
    August 22, 2012
    Date of Event
    July 31, 2012
    Report Date
    July 31, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTN
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR LOT # T102704 REVEALED THE BUTTRESS/COMPRESSION NUT FOR 357.369 WAS MANUFACTURED BY TROUTMAN INDUSTRIES, INC. THE SUPPLIER LOT BECAME SYNTHES LOT # 6215449. NO ADDITIONAL INSPECTIONS WERE PERFORMED AT SYNTHES USA. THERE WERE NO NCRS ASSOCIATED WITH THIS LOT NUMBER. THE UNIT HAS SCUFF MARKS ON THE TOP, DEEP INDENTIONS IN THE KNURL FINISH AND SOME DISCOLORATION. THE THREADS APPEAR TO BE IN GOOD SHAPE. THE INSTRUMENT CONFORMED TO DIMENSIONAL SPECIFICATION AT THE TIME OF MANUFACTURING. THE UNIT RETURNED FOR THE COMPLAINT MET DIMENSIONAL INSPECTIONS FOR THREADS.

    Description of Event or Problem · 1

    DURING A TFN PROCEDURE- RIGHT HIP, THE SURGEON WAS USING THE STEPPED DRILL BIT. A 2.4MM PIECE OF THE DRILL BIT BROKE OFF IN THE FEMORAL NECK. THE SURGEON COULD NOT RETRIEVE THE PIECE AND THE PIECE REMAINS IN THE FEMORAL NECK OF THE PATIENT. POST OP X-RAYS SHOWS THE TIP OF THE BROKEN DRILL BIT IS NEXT TO THE HELICAL BLADE. IT WAS NOTED THE FACILITY WAS CONCERNED THE WHOLE SYSTEM IS OFF ANGLE AND MISALIGNED. SURGEON MANIPULATED THE SET TO COMPLETE THE PROCEDURE SUCCESSFULLY, THE HELICAL BLADE WAS INSERTED WITHOUT DIFFICULTY, AND THERE WERE NO FURTHER INCIDENTS AND NO INTRAOPERATIVE ADVERSE EFFECT TO THE PATIENT WAS NOTED. PROCEDURE WAS DELAYED APPROXIMATELY ONE (1) HOUR. THIS IS 3 OF 5 REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BUTTRESS/ COMPRESSION NUT FOR 357.369 BUTTRESS/ COMPRESSION NUT HTN SYNTHES MONUMENT T102704

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR