BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TORQUE LIMITING DRIVER HANDLE

    MDR report key: 18159499 · Received November 17, 2023

    Report

    Report Number
    1000306694-2023-00001
    Event Type
    Injury
    Date Received
    November 17, 2023
    Date of Event
    October 22, 2018
    Report Date
    November 15, 2023
    Manufacturer
    TECOMET, INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPTNA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE INCIDENT DESCRIBED IN THIS FORM WAS REPORTED IN THE MAUDE DATABASE BY STRYKER/ WRIGHT MEDICAL TECHNOLOGY INC ON (B)(6) 2018 UNDER REPORT NUMBER 1043534-2018-00189. HOWEVER, TECOMET KENOSHA WAS NOTIFIED BY STRYKER/ WRIGHT MEDICAL TECHNOLOGY INC ABOUT THIS INCIDENT ON 12-OCT-2023. GIVEN THIS DELAY IN BECOMING AWARE, AVAILABLE DOCUMENTATION WAS LIMITED TO THE MAUDE REPORT SUBMITTED IN NOV 2018, THE TGA INITIAL REPORT SUBMITTED ON 07-NOV-2018 AND THE WRIGHT MEDICAL COMPLAINT REPORT (B)(4). THROUGH MULTIPLE FOLLOW UP CALLS WITH STRYKER/WRIGHT MEDICAL, TECOMET KENOSHA WAS INFORMED THAT NO ADDITIONAL DETAILS REGARDING THIS EVENT WERE AVAILABLE. THE RESPECTIVE TGA INITIAL REPORT AND THE WRIGHT MEDICAL INTERNAL COMPLAINT REPORT DOES NOT CONTAIN ANY ADDITIONAL SUBSTANTIVE INFORMATION. P/N 58871012 WAS MANUFACTURED AT THE TECOMET KENOSHA WI FACILITY AS PART OF A 100 PC LOT IN JANUARY 2012. THE MEDICAL DEVICE ASSOCIATED WITH THIS MDR WAS NOT RETURNED FOR REVIEW OR EVALUATION. THEREFORE, OUR INTERNAL EVALUATION WAS LIMITED TO A DHR REVIEW. THE DHR FOR THIS LOT WAS REVIEWED AND FOUND COMPLETE WITHOUT ANY IRREGULARITIES. IT WAS FOUND THAT THIS ORDER WAS MADE FROM THE CORRECT MATERIALS AND COMPONENTS AND ALL APPROVED PROCESSES WERE FOLLOWED. THESE DEVICES WERE INSPECTED AND FUNCTIONALLY TESTED/CERTIFIED FOR TORQUE RANGE PRIOR TO SHIPPING TO STRYKER/ WRIGHT MEDICAL AND DEEMED FUNCTIONAL AT THAT TIME. A REVIEW OF TECOMET KENOSHA'S COMPLAINT DATABASE INDICATED NO COMPLAINT REPORTS WERE RECEIVED PRIOR TO OCTOBER 2023 FOR P/N 58871012. A REVIEW OF THE FDA MAUDE DATABASE FOR TECOMET KENOSHA FROM JANUARY 2020- NOVEMBER 2023 INDICATED NO ADVERSE EVENT WAS REPORTED FOR OVER TORQUING. NO SIMILAR COMPLAINTS WERE IDENTIFIED EITHER BY STRYKER/ WRIGHT MEDICAL OR BY TECOMET SINCE THE DEVICE WAS PLACED ON MARKET. BASED ON THE ABOVE ASSESSMENT, TECOMET KENOSHA HAS DETERMINED THAT THE PATIENT SAFETY RISK OF USING THIS DEVICE IS LOW.

    Description of Event or Problem · 0

    THE INCIDENT DESCRIBED IN THIS FORM WAS REPORTED IN THE MAUDE DATABASE BY WRIGHT MEDICAL TECHNOLOGY INC ON (B)(6) 2018 UNDER REPORT NUMBER 1043534-2018-00189. HOWEVER TECOMET KENOSHA WAS NOTIFIED BY STRYKER/ WRIGHT MEDICAL TECHNOLOGY INC ABOUT THIS INCIDENT ON 12-OCT-2023. AS DESCRIBED IN THE MAUDE REPORT BY WRIGHT MEDICAL, "ALLEGEDLY, THE TORQUE LIMITING SCREW DRIVER IN THE KIT APPEARED TO NOT STOP A SCREW AND RESULTED IN A FRACTURE OF THE 1ST METETARSAL. THE SURGEON PUT IN EXTRA SCREWS TO PROVIDE FURTHER FIXATION TO CORRECT THE FRACTURE. THE SURGERY WAS COMPLETED WITHOUT FURTHER ISSUE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322083 TORQUE LIMITING DRIVER HANDLE Orthopedic manual surgical instrument LXH TECOMET, INC. 995234

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention