BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T-FIX RCG STERILE PAC

    MDR report key: 23569519 · Received November 17, 2025

    Report

    Report Number
    1219602-2025-02890
    Event Type
    Malfunction
    Date Received
    November 17, 2025
    Date of Event
    October 28, 2025
    Report Date
    December 15, 2025
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HRX
    UDI-DI
    03596010446114
    PMA / PMN Number
    K925573
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H11: INTERNAL COMPLAINT REFERENCE: (B)(4).

    Additional Manufacturer Narrative · 0

    H11: H3, H6: THE REPORTED DEVICE WAS RECEIVED FOR EVALUATION. A VISUAL EVALUATION SHOWED THAT TWO DRILL SLEEVES AND ONE FRACTURED DRILL WERE RETURNED WITHOUT ANY ORIGINAL PACKAGING. THE SLOT FOR SECURING THE DRILL AT THE PROXIMAL SLEEVE END OF ONE SLEEVE IS DEFORMED. THE SECOND SLEEVE HAS NO VISIBLE DEFECT. THE DRILL IS FRACTURED AT THE PROXIMAL END OF THE DRILL UNDER THE WELDS. THE WELDS ARE INTACT. A REVIEW OF DEVICE RECORDS SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATIONS UPON RELEASE FOR DISTRIBUTION. A COMPLAINT HISTORY REVIEW FOUND ONE SIMILAR REPORTED EVENT. A RISK MANAGEMENT REVIEW FOUND THAT THE REPORTED FAILURE AND/OR HARM WAS DOCUMENTED APPROPRIATELY, AND THERE WERE NO INDICATIONS TO SUGGEST THE ANTICIPATED RISK IS NOT ADEQUATE. A DEFINITIVE ROOT CAUSE FOR THE REPORTED ISSUE COULD NOT BE DETERMINED. FACTORS THAT COULD HAVE CONTRIBUTED TO THE FAILURE INCLUDE PROCEDURAL VARIANCE, OR DEVIATIONS FROM ESTABLISHED PROTOCOLS, INCREASING RISKS AND LEADING TO UNINTENDED CONSEQUENCES (EXCESSIVE FORCE ON THE DEVICE OR AN INADVERTENT IMPACT EVENT). BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PROCEDURE, WHILE DRILLING INTO THE GLENOID THROUGH THE GUIDE, THE INNER DRILL OF THE T-FIX RCG STERILE PAC WAS BROKEN. ALL BROKEN PIECES WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT SN BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2875207 T-FIX RCG STERILE PAC ARTHROSCOPE HRX SMITH & NEPHEW, INC. 2183151 03596010446114

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Female