BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAP/REAMER FOR TROCHANTERIC FIXATION NAIL SCREW

    MDR report key: 2838169 · Received November 19, 2012

    Report

    Report Number
    1719045-2012-01157
    Event Type
    Malfunction
    Date Received
    November 19, 2012
    Date of Event
    October 23, 2012
    Report Date
    October 23, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED AS TREATMENT. A REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR LOT PE00932 REVEALED THE TAP/REAMER WAS MANUFACTURED BY PRECISION EDGE. SYNTHES RECEIVED FIVE SHIPMENTS OF THIS LOT. PO 1243345, DATED (B)(4) 2011, FOR 40 PARTS, WAS INSPECTED TO THE SYNTHES INCOMING FINAL INSPECTION SHEET AND THE PRODUCT CONFORMED TO ALL REQUIREMENTS. LASER WELDING 440A TO 440A IS A VERY DIFFICULT PROCESS AND THE VENDOR HAS REQUESTED A CHANGE TO MAKE THE HANDLE FROM A MORE COMPATIBLE MATERIAL. A DESIGN CHANGE WAS MADE ON RELEASED ON (B)(4) 2012 TO CHANGE THE HANDLE FROM 440A TO 17-4 STAINLESS STEEL. THE RETURNED DEVICE WAS MANUFACTURED IN MARCH 2011 WHICH IS PRIOR TO THE MATERIAL CHANGE BEING MADE AND IMPLEMENTED IN FEBRUARY 2012. THE RISK ANALYSIS ADEQUATELY ADDRESSES THIS COMPLAINT CONDITION.

    Description of Event or Problem · 1

    DURING A TFN FEMUR NAIL PROCEDURE, THE SURGEON WANTED TO USE THE TAP, REAMER INSTRUMENT TO TAP THE LAG SCREWS IN FOR THE PROCEDURE BECAUSE OF THE PATIENT'S AGE. WHEN THE TAP INSTRUMENT WAS PICKED UP OUT OF THE TRAY IT BROKE AT THE WELD OF THE INSTRUMENT AND WAS NOW IN TWO PIECES. THE SURGEON COMPLETED THE PROCEDURE WITHOUT USING THE TAP INSTRUMENT BECAUSE IT WAS UNUSABLE. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAP/REAMER FOR TROCHANTERIC FIXATION NAIL SCREW TAP/REAMER HTO SYNTHES MONUMENT PE00932

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR