BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM

    MDR report key: 23262173 · Received October 9, 2025

    Report

    Report Number
    3000327445-2024-00007
    Event Type
    Injury
    Date Received
    October 9, 2025
    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
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOWING CONSULTATION WITH THE HOSPITAL REPRESENTATIVE, IT WAS CONFIRMED THAT SURGEONS AT (B)(6) HOSPITAL DO NOT UTILIZE SLIM CAPS WHEN INSERTING SLIM NAILS. THE ABSENCE OF SLIM CAPS ALLOWS DEBRIS, INCLUDING BONE AND SOFT TISSUE, TO ACCUMULATE IN THE HEAD AND INTERNAL THREADS OF THE DEVICE. THIS ACCUMULATION CAN LEAD TO DAMAGE TO THE DRIVER'S THREADS DURING IMPLANT REMOVAL. ORTHOPEDIATRICS CANADA PROVIDES WARNINGS IN THE DEVICE LABELING THAT EMPHASIZE THE IMPORTANCE OF CLEANING INTERNAL FEATURES OF THE IMPLANT TO REMOVE ANY BONE OR SOFT TISSUE INGROWTHS PRIOR TO REMOVAL, ESPECIALLY IF A SLIM CAP WAS NOT USED. ADDITIONALLY, THE SURGICAL TECHNIQUE GUIDE OUTLINES TWO ALTERNATIVE OPTIONS FOR IMPLANT EXTRACTION IN SCENARIOS WHERE SLIM CAPS ARE NOT EMPLOYED. THESE RECOMMENDATIONS ARE INTENDED TO MITIGATE POTENTIAL DAMAGE TO THE DEVICE DURING REMOVAL AND ENSURE SUCCESSFUL RETRIEVAL OF THE IMPLANT. FINALLY, ORTHOPEDIATRICS CANADA PROVIDES CLEAR INSTRUCTIONS ON HOW TO PROPERLY MAINTAIN AND INSPECT REUSABLE INSTRUMENTS AFTER EACH USE TO DETECT THIS TYPE OF DAMAGE AND TO AVOID HAVING DAMAGED INSTRUMENTS USED IN SUBSEQUENT SURGERIES. NOTE: THIS MDR WAS ORIGINALLY SUBMITTED AS MFR #3000327-2024-00007 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

    THE SLIM DRIVERS (B)(6) USED AT (B)(6) HOSPITAL ARE CONSISTENTLY FAILING TO THREAD INTO THE HEADS OF THE NAILS DURING PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1577710 SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM SLIM DRIVER FOR ØXX, XX & XX MM RODS HXX ORTHOPEDIATRICS CANADA ULC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other