BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TFNA SCREW 85MM

    MDR report key: 13620534 · Received February 28, 2022

    Report

    Report Number
    2939274-2022-00686
    Event Type
    Injury
    Date Received
    February 28, 2022
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HSB
    UDI-DI
    10886982098443
    PMA / PMN Number
    K131548
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART # 04.038.085; SYNTHES LOT # H021724; RELEASE TO WAREHOUSE DATE:08 MAR 2016; MANUFACTURING LOCATION: (B)(4). NO NCR'S WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUB-COMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 · 0

    IT WAS REPORTED THAT ON (B)(6) 2022, THE SURGEON REMOVED A TFNA NAIL TO CONVERT THE PATIENT TO A TOTAL HIP. PATIENT WAS IN PAIN AND HAS ARTHRITIS OF HER HIP. ALL TFNA IMPLANTS WERE REMOVED SUCCESSFULLY. PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) TFNA SCREW 85MM. THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    883160 TFNA SCREW 85MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB WRIGHTS LANE SYNTHES USA PRODUCTS LLC 04.038.085 H021724 10886982098443

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention 12/125 DEG TI CANN TFNA 400/RIGHT - SILE| 5.0 TI LOCKING SCREW 80- FOR IM NAILS| LOCKSCR Ø5 SELF-TAP L48 TAN