BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM

    MDR report key: 23267562 · Received October 10, 2025

    Report

    Report Number
    3000327445-2025-00003
    Event Type
    Injury
    Date Received
    October 10, 2025
    Date of Event
    May 12, 2025
    Report Date
    October 10, 2025
    Manufacturer
    ORTHOPEDIATRICS CANADA ULC
    Product Code
    HXX
    PMA / PMN Number
    K143355
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE HOSPITAL REPRESENTATIVE REPORTED THAT DURING THE REMOVAL OF A 2.6MM SLIM NAIL, THE CORRELATING DRIVER (SLM-DRV123) WAS UNABLE TO CAPTURE THE NAIL. THE SURGEON ATTEMPTED TO USE THE RESCUE DRIVER (SLM-RSC123) AS A SECONDARY OPTION, WHICH MANAGED TO PARTIALLY BACK THE NAIL OUT BUT LEFT A FEW THREADS STILL ENGAGED IN THE BONE. THE SURGEON ULTIMATELY RESORTED TO USING PLIERS TO EXTRACT THE NAIL. THE INCIDENT CAUSED A SURGICAL DELAY OF OVER 30 MINUTES. AS THIS WAS AN OSTEOGENESIS IMPERFECTA (OI) PATIENT, THE MORE AGGRESSIVE REMOVAL TECHNIQUE RESULTED IN ADDITIONAL BONE DAMAGE. THE OSTEOGENESIS IMPERFECTA IS A CONDITION CHARACTERIZED BY BRITTLE BONES. BASED ON THE INFORMATION AVAILABLE, THE DAMAGE SUSTAINED IS BEING MANAGED ACCORDING TO STANDARD CLINICAL PRACTICES FOR OI PATIENTS AND IS NOT EXPECTED TO RESULT IN PERMANENT IMPAIRMENT OF BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE. THE SLIM DRIVER INVOLVED IN THIS EVENT, LOT NUMBER 160421-01, WAS MANUFACTURED IN SEPTEMBER 2016 AND HAD BEEN IN CLINICAL USE SINCE THEN WITHOUT ANY PRIOR COMPLAINTS REPORTED. DAMAGE TO THE THREADED TIP OF SLIM DRIVERS IS A KNOWN ISSUE, TYPICALLY OCCURRING DURING NAIL REMOVAL PROCEDURES. WHEN DRIVERS ARE USED ON IMPLANT HEADS CONTAINING ACCUMULATED BONE OR SOFT TISSUE DEBRIS, THE THREADS CAN BECOME PROGRESSIVELY DAMAGED. ONCE COMPROMISED, THE DRIVER MAY NO LONGER SECURELY ENGAGE WITH THE IMPLANT. IF SUCH DAMAGE GOES UNNOTICED AFTER A PROCEDURE, IT CAN LEAD TO FUNCTIONAL FAILURE IN SUBSEQUENT SURGERIES. SPECIFICALLY, IF THE THREADS ARE STRIPPED OR DEFORMED, THE DRIVER WILL FAIL TO CAPTURE THE IMPLANT HEAD, POTENTIALLY LEADING TO DETACHMENT DURING REMOVAL AS OCCURRED IN THIS CASE. ORTHOPEDIATRICS CANADA PROVIDES CLEAR INSTRUCTIONS FOR THE MAINTENANCE, INSPECTION, AND EVALUATION OF REUSABLE INSTRUMENTS AFTER EACH USE, AIMED AT DETECTING SUCH DAMAGE AND PREVENTING COMPROMISED DEVICES FROM BEING RE-USED. IN THIS CASE, BASED ON THE INFORMATION RECEIVED AND A REVIEW OF SIMILAR PAST INCIDENTS, IT CAN BE CONCLUDED THAT THE MOST PROBABLE CAUSE OF THE EVENT WAS NOT A DEVICE MALFUNCTION BUT PROGRESSIVE THREAD DAMAGE TO THE DRIVER OVER TIME. THIS CONCLUSION IS FURTHER SUPPORTED BY THE FACT THAT THE DRIVER HAD BEEN IN ACTIVE USE FOR NEARLY NINE YEARS WITHOUT ANY PRIOR COMPLAINTS. NOTE: THIS MDR WAS ORIGINALLY SUBMITTED AS MFR ON JUNE 12, 2025, 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 SURGEON WAS UNABLE TO CAPTURE A 2.6 MM SLIM NAIL WITH DRIVER SLIM-DRV123.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310133 SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM SLIM DRIVER FOR Ø2.0, 2.6 & 3.2 MM RODS HXX ORTHOPEDIATRICS CANADA ULC 160421-01

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Female Other