BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM

    MDR report key: 3076299 · Received April 25, 2013

    Report

    Report Number
    2520274-2013-02130
    Event Type
    Injury
    Date Received
    April 25, 2013
    Report Date
    March 27, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HSB
    PMA / PMN Number
    K011857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. LOT #: THE LOT # WAS REPORTED AS 710213; THIS IS AN INVALID SYNTHES LOT #. FURTHER INVESTIGATION IN (B)(4) NOTED THAT THE LOT # COULD BE EITHER 7102133 OR 7102132; HOWEVER, THE LOT # COULD BE CONFIRMED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A DEVICE HISTORY RECORD REVIEW CANNOT BE PERFORMED WITHOUT THE CORRECT LOT NUMBER.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH TROCHANTERIC FIXATION NAIL, HELICAL BLADE AND DISTAL LOCKING SCREW CONSTRUCT ON (B)(6) 2013. IMAGING TAKEN ON AN UNSPECIFIED DATE REVEALED THE HELICAL BLADE HAD MIGRATED THROUGH THE FEMORAL HEAD AND ADVANCED INTO THE JOINT. PATIENT WAS RETURNED TO THE OR ON (B)(6) 2013 FOR REVISION SURGERY. ALL HARDWARE WAS REMOVED AND THE PATIENT WAS REVISED TO A NEW TFN CONSTRUCT. THE HARDWARE WAS DISCARDED OF. THIS IS 2 OF 2 REPORTS FOR THE SAME EVENT, COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180671 11MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM HSB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Required Intervention