BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 5430389 · Received February 11, 2016

    Report

    Report Number
    1719045-2016-10121
    Event Type
    Injury
    Date Received
    February 11, 2016
    Report Date
    January 21, 2016
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    PK011857
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT AGE AND WEIGHT WERE NOT PROVIDED BY THE REPORTER. ADDITIONAL DEVICE PRODUCT CODE IS HWC. THE REPORTED LOT NUMBER, 7447194, CORRESPONDS TO PART NUMBER 456.420S, BRAND NAME 11MM/130 DEG TI CANN TROCH FIXATION NAIL 400MM/RIGHT-STERILE, DEVICE PRODUCT CODES - HSB AND HWC, COMMON DEVICE NAME - ROD, FIXATION, INTRAMEDULLARY, 510(K) K011857, NOT SIMILAR PART NUMBER, 456.417, AS REPORTED. THE REPORTED PART/LOT NUMBER COMBINATION COULD NOT BE VALIDATED. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE INITIAL REPORTER AND IS PENDING RESPONSE AND/OR RECEIPT OF THE REPORTED DEVICE. DATE OF IMPLANT IS UNKNOWN. THE SUBJECT DEVICE IS EXPECTED TO BE RETURNED TO THE SYNTHES MANUFACTURER FOR EVALUATION. WITHOUT A VALID PART/LOT NUMBER COMBINATION 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. 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 DURING A PLANNED TFN (TROCHANTERIC FIXATION NAIL) EXPLANT DUE TO NEED TO REMOVE CANCEROUS TUMORS AND BONE, A DISTAL INTERLOCKING SCREW WAS NOTED TO BE BROKEN. THE ORIGINAL IMPLANT DATE OF THE TFN SYSTEM IS UNKNOWN. THE SURGEON DECIDED TO LEAVE THE BROKEN SCREW SHAFT IN THE PATIENT'S BONE. THE NAIL WAS NOTED TO HAVE STRESS MARKS UPON REMOVAL. THE PATIENT HAD A HEMIARTHROPLASTY TO TREAT OTHER FRACTURES. THE PATIENT'S POSTSURGICAL OUTCOME IS UNKNOWN. THERE WAS NO REPORT OF SURGICAL DELAY OR ADDITIONAL MEDICAL INTERVENTION. THIS REPORT IS 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87409 11MM/130 DEG TI CANN TROCH FIXATION NAIL 360MM/LEFT ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES MONUMENT 7447194

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention