BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULLUP INSTRUMENTATION

    MDR report key: 21431608 · Received February 21, 2025

    Report

    Report Number
    3004549189-2025-00003
    Event Type
    Injury
    Date Received
    February 21, 2025
    Date of Event
    February 7, 2025
    Report Date
    May 27, 2025
    Manufacturer
    S.B.M. SAS
    Product Code
    HTW
    UDI-DI
    03760154006163
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6) 2025 NOT ENOUGH ELEMENTS TO CONTINUE OUR INVESTIGATIONS. NO PHOTOS. LOT NUMBER NOT COMMUNICATED: WAITING FOR BATCH NUMBER TO VERIFY INSTRUMENT MANUFACTURING DATA. INSTRUMENT WAS DISCARDED: NOT AVAILABLE FOR EXPERTISE. WAITING FURTHER INFORMATION ON THE POTENTIAL CONSEQUENCES FOR THE PATIENT AND THE CIRCUMSTANCES OF THE INCIDENT. ____________________________________________________

    Additional Manufacturer Narrative · 0

    20 FEBRUARY 2025: NOT ENOUGH ELEMENTS TO CONTINUE OUR INVESTIGATIONS. NO PHOTOS. LOT NUMBER NOT COMMUNICATED: WAITING FOR BATCH NUMBER TO VERIFY INSTRUMENT MANUFACTURING DATA. INSTRUMENT WAS DISCARDED: NOT AVAILABLE FOR EXPERTISE. WAITING FURTHER INFORMATION ON THE POTENTIAL CONSEQUENCES FOR THE PATIENT AND THE CIRCUMSTANCES OF THE INCIDENT. 27 MAY 2025: ADDITIONAL INFORMATION / RESULT OF ANALYSIS. CIRCUMSTANCES OF THE EVENT: "THE DRILL BIT EXPLODED IN 5 PIECES WITHOUT ENTERING THE FEMUR". LOT IDENTIFICATION AFTER VERIFICATION: LOT 232764. DEVICE NOT AVAILABLE FOR ANALYSIS / NO PHOTOS. INSTRUMENT ON DEPOSIT SINCE JANUARY 2024. REVIEW OF MANUFACTURING HISTORY: DRILL MANUFACTURING IS NOT CONSIDERED TO BE THE CAUSE OF THE FAILURE. ADDITIONAL ANALYSES: *TESTS TO VERIFY THE CUTTING PERFORMANCE OF LIGAFIX INSTRUMENTATION CUTTING TOOLS: RESULTS IN COMPLIANCE. *CHECK OF THE MINIMUM THICKNESS AT THE BOTTOM OF THE FLUTE AFTER CUTTING A DRILL FROM THE SAME BATCH / RESULT COMPLIANT (>OR= 0.35MM FOR A SPECIFICATION OF 0.3MM MIN). POSSIBLE CAUSES IDENTIFIED: HYPOTHESIS N°1: BREAKAGE DUE TO IMPACT OR CONTACT OF ONE OF THE CUTTING EDGES WITH A STAINLESS-STEEL PIN, SHAVER, SIGHT OR OTHER INSTRUMENT. HYPOTHESIS 2: DRILL BLUNTED DURING PREVIOUS OPERATIONS, REQUIRING THE SURGEON TO APPLY THRUST TO ADVANCE THE DRILL INTO THE BONE. THE APPLICATION OF PUSHING FORCES RESULTS IN BENDING DEFORMATION OF THE DRILL, WHICH COULD CAUSE SEVERAL OR A COMBINATION OF DAMAGE. THE INVESTIGATION FINDINGS DO NOT LEAD TO A CLEAR CONCLUSION ABOUT THE CAUSE. NO CORRECTIVE OR PREVENTIVE ACTION IMPLEMENTED.

    Description of Event or Problem · 0

    FNCONF-25-0031 INCIDENT OCCURED IN FRANCE. EVENT DESCRIPTION COMMUNICATED. "DURING THE LIGAMENTOPLASTY PROCEDURE, THE 4.5MM DIAMETER CANNULATED DRILL (REF. (B)(6) BROKE IN THE PATIENT'S KNEE, WITH MANY PIECES OF METAL TO BE RECOVERED FROM THE PATIENT'S KNEE JOINT. THE INSTRUMENT BROKE LENGTHWISE. THIS INCIDENT SIGNIFICANTLY INCREASED SURGERY TIME".

    Description of Event or Problem · 0

    FNCONF-25-0031. INCIDENT OCCURED IN FRANCE. EVENT DESCRIPTION COMMUNICATED. "DURING THE LIGAMENTOPLASTY PROCEDURE, THE 4.5MM DIAMETER CANNULATED DRILL (REF. PULL000255) BROKE IN THE PATIENT'S KNEE, WITH MANY PIECES OF METAL TO BE RECOVERED FROM THE PATIENT'S KNEE JOINT. THE INSTRUMENT BROKE LENGTHWISE. THIS INCIDENT SIGNIFICANTLY INCREASED SURGERY TIME".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1045985 PULLUP INSTRUMENTATION Ø 4.5MM CANNULATED DRILL BIT HTW S.B.M. SAS 232764 03760154006163

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Male Other