BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TWNFX TI 3.5 STR ANCHR W/2 ULTRB STR N

    MDR report key: 10378417 · Received August 7, 2020

    Report

    Report Number
    1219602-2020-01196
    Event Type
    Injury
    Date Received
    August 7, 2020
    Date of Event
    July 14, 2020
    Report Date
    September 6, 2020
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    MBI
    UDI-DI
    03596010532190
    PMA / PMN Number
    K972326
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED 7210707 TWNFX TI 3.5 STR ANCHR W/2 ULTRB STR N, INTENDED FOR USE IN TREATMENT, HAS NOT BEEN RETURNED FOR EVALUATION. WITHOUT THE REPORTED PRODUCT, A VISUAL OR FUNCTIONAL EVALUATION CANNOT BE PERFORMED AND THE CUSTOMERS COMPLAINT CANNOT BE CONFIRMED. FROM THE INFORMATION PROVIDED, ¿WHEN FINALIZING THE ELBOW PROSTHESIS, THE SPECIALIST WAS PREPARING TO RELIABLY LIGAMENT, USING A 3.5MM CALIBER TITANIUM ANCHOR, HE DECIDED TO MAKE WAY FOR THE ANCHOR WITH A PIN¿. AN EXACT ROOT CAUSE CANNOT BE DETERMINED WITH CONFIDENCE. THE INSTRUCTION FOR USE OUTLINES PRECAUTIONARY STATEMENTS AND INSTRUCTIONS IN REGARDS TO THE USE OF THE DEVICE TO AVOID DAMAGE OR NON-FUNCTIONALITY. THERE WERE NO INDICATIONS THAT WOULD SUGGEST THAT THE DEVICE DID NOT MEET PRODUCT SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION. A REVIEW OF COMPLAINTS AND MANUFACTURING BATCH RECORDS WAS PERFORMED, NO OTHER COMPLAINTS OF THIS FAILURE WAS FOUND. FURTHER INVESTIGATION IS NOT WARRANTED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN FINALIZING THE ELBOW PROSTHESIS, THE SPECIALIST WAS PREPARING TO RELIABLY LIGAMENT, USING A 3.5MM CALIBER TITANIUM ANCHOR, HE DECIDED TO MAKE WAY FOR THE ANCHOR WITH A PIN, BEGAN TO INSERT THE DEVICE INTO THE PATIENT'S BONE AND AT THE MOMENT OF REMAINING TWO THREADED STEPS, THE ANCHOR HOLDING HANDLE WAS BENT AND IT WAS NO LONGER POSSIBLE TO FINISH IMMERSING IT IN THE BONE. IN ORDER TO FINISH IMMERSING THE IMPLANT, THE SURGEON HAD TO HAMMER THE ANCHOR DIRECTLY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE WITH NO SIGNIFICANT DELAY OR OTHER COMPLICATIONS. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    842184 TWNFX TI 3.5 STR ANCHR W/2 ULTRB STR N FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI SMITH & NEPHEW, INC. 7210707 2039216 03596010532190

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention