BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    11MM/130 DEG TI CANN TROCH FIXATION NAIL 360MM/LEFT-STER

    MDR report key: 4240337 · Received November 10, 2014

    Report

    Report Number
    1719045-2014-10574
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Report Date
    October 15, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    PK011857
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODE: HWC. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A DEVICE HISTORY REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT IT REVEALED NO COMPLAINT RELATED ISSUES. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEMALE PATIENT WAS REVISED FROM A TROCHANTERIC FIXATION NAIL (TFN) TO A BIPOLAR HIP DUE TO COMPLAINTS OF PAIN. THE PATIENT WAS IMPLANTED WITH A TFN, HELICAL BLADE AND TWO 5.0 MILLIMETER LOCKING SCREWS ON (B)(6), 2014 FOR TREATMENT OF A HIP FRACTURE. RECENTLY, THE PATIENT COMPLAINED OF HIP PAIN. AN X-RAY REVEALED THAT THE HELICAL BLADE HAD CUT THROUGH THE PROXIMAL PORTION OF THE FEMORAL HEAD. DUE TO THE PAIN AND LOSS OF FIXATION, THE SURGEON DECIDED TO REMOVE THE TFN AND REVISE IT WITH A BIPOLAR HIP. THE PATIENT UNDERWENT THE REVISION ON (B)(6), 2014. IT WAS REPORTED THAT SURGERY WENT SMOOTHLY WITH NO DELAYS IN THE REMOVAL OF THE TFN, HELICAL BLADE AND SCREWS. THE PATIENT OUTCOME WAS SUCCESSFUL AFTER THE REMOVAL. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722393 11MM/130 DEG TI CANN TROCH FIXATION NAIL 360MM/LEFT-STER ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES MONUMENT 7292003

    Patients

    Seq Age Sex Outcome Treatment
    1