BEUDAMED
    FDA Adverse Event Injury Summary report: N

    12MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE

    MDR report key: 2850021 · Received November 29, 2012

    Report

    Report Number
    1719045-2012-01210
    Event Type
    Injury
    Date Received
    November 29, 2012
    Date of Event
    October 30, 2012
    Report Date
    November 1, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    K011857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. NOTE: BLANK FIELDS ON THIS FORM INDICATE INFORMATION THAT IS UNKNOWN, UNAVAILABLE OR UNCHANGED. PLACEHOLDER.

    Description of Event or Problem · 1

    DURING A HIP FRACTURE PROCEDURE, THE SURGEON ATTEMPTED TO INSERT THE 12MM 130 DEGREE NAIL INTO THE PATIENTS FEMORAL CANAL BUT ENCOUNTERED DIFFICULTY. SURGEON ATTEMPTED NUMEROUS TIMES TO INSERT THE NAIL. ANOTHER NAIL WAS FINALLY USED FOR INSERTION. THE SALES CONSULTANT WAS NOTIFIED. PROCEDURE WAS DEMONSTRATED TO THE SALES CONSULTANT AND IT WAS NOTICED THAT THE SCRUB TECHNICIAN HAD USED THE WRONG SCREWDRIVER TO ATTEMPT TO CONNECT THE NAIL TO THE INSERTION HANDLE, CAUSING THE LOCKING MECHANISM WITHIN THE NAIL TO DEPLOY. SCRUB TECH USED THE CORRECT SCREWDRIVER TO TIGHTEN THE CONNECTION TO THE INSERTION HANDLE, BUT FAILED TO BACK UP THE LOCKING MECHANISM. THE TFN FIXATION SCREW WOULD NOT PASS THROUGH THE INTERFACE IF THE LOCKING MECHANISM WAS DEPLOYED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 12MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE NAIL HSB SYNTHES MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention