BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM

    MDR report key: 23262114 · Received October 9, 2025

    Report

    Report Number
    3000327445-2024-00008
    Event Type
    Injury
    Date Received
    October 9, 2025
    Date of Event
    November 11, 2024
    Report Date
    October 9, 2025
    Manufacturer
    ORTHOPEDIATRICS CANADA ULC
    Product Code
    HXX
    PMA / PMN Number
    K192710
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER DISCUSSIONS WITH THE HOSPITAL REPRESENTATIVE AND THE SURGEON, IT WAS NOTED THAT THE SURGEON USED THE SLIM WRENCH TO TIGHTEN THE SLIM DRIVER INTO THE IMPLANT AND APPLIED EXCESSIVE FORCE WITH THE SLIM MALLET, REPEATEDLY STRIKING THE DRIVER WITH SIGNIFICANT INTENSITY. WHEN THE DRIVER THREAD IS OVERTIGHTENED USING THE WRENCH, IT CAN DEFORM THE THREAD, RENDERING IT UNUSABLE. OVERTIGHTENING ALSO PLACES ADDITIONAL STRESS ON THE THREAD DURING SUBSEQUENT MANIPULATIONS WITH THE DRIVER, INCREASING THE LIKELIHOOD OF FAILURE. COMBINED WITH EXCESSIVE MALLETING USING THE SLIM MALLET, THE THREADED TIP IS HIGHLY LIKELY TO BREAK. EVEN IF THE THREADED TIP DOES NOT IMMEDIATELY BREAK, THE MALLETING CAN FURTHER DEFORM THE THREAD, CAUSING IT TO LOOSEN WITHIN THE IMPLANT HEAD AND POTENTIALLY DISENGAGE. WHEN THE DRIVER THREAD IS PROPERLY TIGHTENED, THE STRESS SHOULD TRANSFER FROM THE DRIVER TO THE NAIL VIA THE HEX FEATURE, LEAVING THE THREAD UNDER TENSION. HOWEVER, IF THE THREAD LOOSENS, BENDING STRESS IS REDIRECTED INTO THE CAPTURE THREAD, SIGNIFICANTLY INCREASING THE RISK OF FAILURE. NOTE: THIS MDR WAS ORIGINALLY SUBMITTED AS MFR #3000327-2024-00008 ON (B)(6) 2024 BUT WAS REJECTED BY CDRH DUE TO AN INCORRECT FEI NUMBER IN THE ESUBMITTER FORM. IT IS NOW RESUBMITTED WITH THE CORRECT FEI (B)(4). CAPA INITIATED TO ADDRESS THE ISSUE.

    Description of Event or Problem · 0

    DURING A SLIM NAIL PROCEDURE, THE THREADED TIP OF THE SLIM DRIVER BROKE OFF INSIDE THE PATIENT'S NAIL, RENDERING THE DRIVER UNUSABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2029661 SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM SLIM DRIVER FOR Ø4.0, 4.8, 5.6 & 6.4 MM RODS HXX ORTHOPEDIATRICS CANADA ULC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other