BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHROTWIST TCP 8MM L24MM

    MDR report key: 21114427 · Received January 9, 2025

    Report

    Report Number
    3003854593-2025-00001
    Event Type
    Malfunction
    Date Received
    January 9, 2025
    Date of Event
    December 17, 2024
    Report Date
    March 13, 2025
    Manufacturer
    TEKNIMED SAS
    Product Code
    MAI
    PMA / PMN Number
    K230394
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FRAGMENTS OF THE SCREW WERE RECEIVED BY TEKNIMED ON 06-FEB-2025 AND THE VISCOSITY WAS TESTED AND FOUND TO BE IN ACCORDANCE WITH THE TEST PERFORMED DURING MANUFACTURING. NINE SCREWS OF OTHER BATCHES HAVE BEEN SENT BACK FROM THE DISTRIBUTOR TO TEKNIMED AND WERE TESTED. THE VISCOSITIES OF THE SCREWS WERE ALL COMPLIANT AND IN ACCORDANCE WITH MANUFACTURING SPECIFICATIONS. WE CAN CONCLUDE BY THESE FINDINGS THAT THE STORAGE BY THE DISTRIBUTOR IS COMPLIANT. THE DISTRIBUTOR CONFIRMED ORALLY DURING A MEETING ON 27-JAN-2025 THAT THE SCREWDRIVER USED BY THE SURGEON WAS COMPLIANT (NOT TWISTED). DESPITE REQUESTS SENT FROM TEKNIMED TO THE DISTRIBUTOR ON 19-DEC-2024, 02-JAN-2025 AND 07-JAN-2025, AND FROM THE DISTRIBUTOR TO THE SURGEON, IT WAS NOT POSSIBLE TO RECEIVE THE SURGERY REPORT, PRE-OP OR POST OP RADIOS. THEREFORE, IT IS NOT POSSIBLE TO INVESTIGATE THE CASE FURTHER. ROOT CAUSE CONCLUSION: THE RELEASED SCREW WAS COMPLIANT WITH MANUFACTURING SPECIFICATIONS. THE MOST LIKELY CAUSE FOR THE MALFUNCTION WAS DUE TO IMPROPER USE (SCREW NOT ALIGNED, EXCESSIVE PRESSURE WHILE SCREWING, NOT YET ACCUSTOMED TO THIS PRODUCT COMPARED TO OTHER DEVICES PREVIOUSLY USED, ETC.). A SENSITIZATION DOCUMENT HAS BEEN SHARED BY TEKNIMED TO THE DISTRIBUTOR BY EMAIL ON 07-MAR-2025. IT EXPLAINS THAT IT IS NECESSARY TO SCREW GENTLY IN THE AXIS.

    Additional Manufacturer Narrative · 0

    SALES REVIEW: 586 UNITS WERE SOLD WORLDWIDE BETWEEN MARCH AND SEPTEMBER 2024. THIS IS THE FIRST COMPLAINT RECEIVED. BATCH RECORD REVIEW: CONFIRMED BATCH MET SPECIFICATIONS FOR MAX BREAKING TORQUE AND AVERAGE VISCOSITY. ALL THE CONTROLS PERFORMED DURING MANUFACTURING ARE COMPLIANT ACCORDING TO SPECIFICATIONS. THE RELEASED SCREW WAS COMPLIANT. WE HAVE REQUESTED FROM THE CUSTOMER TO RECEIVE THE FOLLOWING ELEMENTS ON DECEMBER 19, 2024: - SURGERY REPORT - PRE-OP AND POST-OP RADIO THE FINAL INVESTIGATIONS WILL BE SHARED IN AN MIR REPORT ONCE THE ELEMENTS HAVE BEEN RECEIVED.

    Description of Event or Problem · 0

    TEKNIMED'S INTERFERENCE SCREW REF: 10001399-PLATCP4 CRACKED DURING SURGERY. DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) DIDT (SEMI-TENDINOUS AND GRACILIS) REVISION BY KENNETH-JONES METHOD, THE FOLLOWING STEPS HAD BEEN PERFORMED: 9MM TUNNEL FOR 9MM TRANSPLANT, TAPPING THEN INSERTION OF 8MM SCREW. THE SCREW CRACKED DURING FEMORAL FIXATION WITH INABILITY TO FINISH RAISING THE SCREW. THE SCREW WAS STICKING OUT BY 12MM, SO REMOVAL WAS DIFFICULT. THERE WAS DEBRIS IN THE JOINT, DAMAGED TRANSPLANT, AND AN ADDITIONAL HOUR OF SURGERY WAS NEEDED WHICH INCLUDED A TOURNIQUET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366508 ARTHROTWIST TCP 8MM L24MM BIOABSORBABLE INTERFERENCE SCREW MAI TEKNIMED SAS 10001399-PLATCP4 7324021

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Male Required Intervention