BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T-FIX RCG STERILE PAC

    MDR report key: 23356131 · Received October 22, 2025

    Report

    Report Number
    1219602-2025-02615
    Event Type
    Malfunction
    Date Received
    October 22, 2025
    Date of Event
    September 10, 2025
    Report Date
    November 24, 2025
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HRX
    UDI-DI
    03596010446114
    PMA / PMN Number
    K925573
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL REFERENCE NUMBER: (B)(4). H3 H6: THIS COMPLAINT WAS OPENED BY SMITH+NEPHEW TO DOCUMENT A PRODUCT PROBLEM ASSOCIATED WITH A SMITH+NEPHEW DEVICE. THE REPORTED PROBLEM RELATES TO KNOWN INHERENT DEVICE AND/OR PROCEDURAL RISKS THAT ARE APPROPRIATELY DOCUMENTED IN OUR RISK FILES. SMITH+NEPHEW WILL CONTINUE TO MONITOR TRENDS IN ACCORDANCE WITH OUR POST-MARKET SURVEILLANCE PROCESS AND TAKE NECESSARY ACTION AS REQUIRED IF ANTICIPATED SEVERITY AND/OR OCCURRENCE RATES ARE EXCEEDED. SMITH+NEPHEW HAS NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY SPECIFICATIONS AT THE TIME OF MANUFACTURE. BASED ON OUR REVIEW OF ALL CURRENTLY AVAILABLE INFORMATION, WE ARE UNABLE TO IDENTIFY A DEFINITIVE ROOT CAUSE. HOWEVER, AS THE USE OF OUR PRODUCT CANNOT BE EXCLUDED AS A POTENTIAL CAUSE OR CONTRIBUTORY FACTOR TO THE REPORTED ISSUE, WE ARE CONSERVATIVELY SUBMITTING THIS REPORT IN ACCORDANCE WITH APPLICABLE REGULATIONS. IF ADDITIONAL INVESTIGATIVE FINDINGS OR INFORMATION BECOMES AVAILABLE THAT ALTERS THE CONCLUSIONS OF THIS REPORT, A FOLLOW-UP REPORT WILL BE SUBMITTED AS REQUIRED.

    Additional Manufacturer Narrative · 0

    H10 H3, H6: THE REPORTED DEVICE WAS RECEIVED FOR EVALUATION. A VISUAL EVALUATION SHOWED THE DEVICE WAS NOT RETURNED IN ORIGINAL PACKAGING. THE LASER WELD ALONG BOTH WINGS AND SHAFT OPENING OF THE DRILL STOP HAVE BEEN BROKEN. THERE IS SCORING ALONG THE PROXIMAL END OF THE DRILL SHAFT. BIO DEBRIS IS PRESENT INSIDE THE DRILL STOP AND ON THE DRILL SHAFT. 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 NO SIMILAR REPORTED EVENTS. 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 (AN IMPACT EVENT TO THE DEVICE INCONSISTENT WITH NORMAL USE OR EXCESSIVE FORCE TO THE DEVICE). BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING A SURGERY, THE WING AT THE TIP OF ONE (1) T-FIX DRILL TIP DISINTEGRATED, BROKE OFF IN THE PATIENT UPON OPENING. THE PROCEDURE WAS RESUMED, AFTER A 10 TO 15-MINUTE DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1403650 T-FIX RCG STERILE PAC ARTHROSCOPE HRX SMITH & NEPHEW, INC. 2162531 03596010446114

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Male