BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: AFN

    MDR report key: 11489886 · Received March 15, 2021

    Report

    Report Number
    2939274-2021-01316
    Event Type
    Injury
    Date Received
    March 15, 2021
    Date of Event
    January 29, 2014
    Report Date
    February 16, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    KTT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THIS REPORT IS FOR AN UNKNOWN CONSTRUCTS: AFN/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: TUNG, T. AND TUFESCU, T. (2014), THE CORTICAL STEP SIGN FAILS TO PREVENT MALROTATION OF A NAILED FEMORAL SHAFT FRACTURE: A CASE REPORT, CASE REPORTS IN ORTHOPEDICS, VOL. 2014, ARTICLE ID 301723, PAGES 1-4 (CANADA). THIS STUDY PRESENTS A CASE REPORT OF AN (B)(6) MALE PATIENT WHO SUSTAINED AN ISOLATED, CLOSED, RIGHT DIAPHYSEAL FEMUR FRACTURE. SURGERY WAS PERFORMED USING AN ANTEGRADE REAMED NAIL (SYNTHES, MISSISSAUGA, ONTARIO). ON POSTOPERATIVE DAY ONE, HE HAD A FEELING THAT HIS RIGHT FOOT WAS EXTERNALLY ROTATED WHEN MOBILIZING. ON EXAMINATION IN THE SUPINE POSITION, A CLINICALLY DETECTABLE EXTERNAL ROTATION OF HIS RIGHT LOWER EXTREMITY WAS NOTED. A CT SCAN OF HIS LOWER EXTREMITIES WAS OBTAINED TO MEASURE THE FEMORAL ROTATION DEFORMITY. ON THE ANTERO-POSTERIOR SCOUT CT IMAGE THE CORTICAL WIDTHS OF THE MEDIAL PROXIMAL AND DISTAL FRAGMENTS WERE EQUAL (FIGURE 2). HOWEVER, APPLYING THE TECHNIQUE DESCRIBED BY JEANMART ET AL. TO THE AXIAL CUTS OF THE SAME CT SCAN, WE MEASURED A ROTATIONAL DEFORMITY OF 15¿ EXTERNAL ROTATION FOR THE RIGHT FEMUR (FIGURE 3). THE PATIENT OPTED FOR A REVISION SURGERY. POSTOPERATIVELY THE PATIENT WAS SATISFIED WITH THE ROTATION OF THE RIGHT LEG. HE MADE AN UNCOMPLICATED RECOVERY THEREAFTER (FIGURE 5). THIS REPORT IS FOR AN UNKNOWN SYNTHES AFN CONSTRUCTS. THIS REPORT IS FOR ONE (1) UNK - CONSTRUCTS: AFN. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376808 UNK - CONSTRUCTS: AFN APPLIANCE, FIXATION, NAIL KTT WRIGHTS LANE SYNTHES USA PRODUCTS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Required Intervention