BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RI.KNEE TIBIA ADJUSTMENT

    MDR report key: 21365395 · Received February 12, 2025

    Report

    Report Number
    3010266064-2025-00041
    Event Type
    Malfunction
    Date Received
    February 12, 2025
    Date of Event
    January 28, 2025
    Report Date
    March 12, 2025
    Manufacturer
    BLUE BELT TECHNOLOGIES
    Product Code
    OLO
    UDI-DI
    09421028118187
    PMA / PMN Number
    K123380
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: AFTER FURTHER ASSESSMENT WHEN THE REPORTED DEVICE RETURNED, IT WAS NOTICED THAT THE CORRECT PART NUMBER WAS "4240-7500" INSTEAD OF "PFSR110009". SMITH+NEPHEW ACTS AS A THE DISTRIBUTOR OF THIS PRODUCT. ENZTEC LTD, THE LEGAL MANUFACTURER WAS NOTIFIED OF THIS COMPLAINT AND IS NOW RESPONSIBLE FOR PERFORMING THE REGULATORY ASSESSMENT AND REPORTING IF REQUIRED. CORRECTED DATA: D1, D2A, D2B, D4 (CATALOG NUMBER, LOT NUMBER, UNIQUE IDENTIFIER (UDI) #).

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING A REAL INTELLIGENCE CORI ASSISTED TKA SURGERY, ONE (1) STRIDE EM TIB ALIGNMENT GUIDE BASE/ARM WAS PLACED IN THE DESIRED LOCATION ON THE TIBIA. A NEW 65 MM HEADLESS PIN WAS DRILLED INTO HOLE. THEN THE PIN APPEARED TO GET STUCK AND WAS NOT SEATED ALL THE WAY DOWN. IT WAS TRIED TO PULL THE PIN OUT, BUT INITIALLY IT WAS NOT POSSIBLE. IT WAS NEEDED TO INCREASE THE FORCE AND A DIFFERENT WIRE DRIVER. ULTIMATELY, IT WAS POSSIBLE TO REMOVE THE MEDIAL PIN FIRST, AND THEN, THE LATERAL PIN FROM THE BONE. HOWEVER, THE LATERAL PIN WAS NOT ABLE TO SEPARATE FROM THE FIXATION BASE ONCE OFF THE BONE. A MALLET WAS USED TO TRY TO SEPARATE THE PIECES. WHEN IT WAS CLEAR THAT THE PIN WAS STUCK, THE PROCEDURE WAS SWITCHED TO MANUAL. THE PIN APPEARED TO BE BENT INTO THE DEVICE. THE PROCEDURE WAS COMPLETED AFTER A NON-SIGNIFICANT DELAY CHANGING TO A MANUAL SURGICAL TECHNIQUE. NO INJURIES WERE REPORTED AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    856651 RI.KNEE TIBIA ADJUSTMENT ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO BLUE BELT TECHNOLOGIES UNKNOWN 09421028118187

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown REAL INTELLIGENCE CORI: ROB10024, (B)(6).