BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM

    MDR report key: 23267561 · Received October 10, 2025

    Report

    Report Number
    3000327445-2024-00009
    Event Type
    Injury
    Date Received
    October 10, 2025
    Date of Event
    November 12, 2024
    Report Date
    October 10, 2025
    Manufacturer
    ORTHOPEDIATRICS CANADA ULC
    Product Code
    HXX
    PMA / PMN Number
    K192710
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER DISCUSSIONS WITH THE HOSPITAL REPRESENTATIVE, IT WAS CONFIRMED THAT THE SLIM DRIVER ARRIVED AT THE HOSPITAL WITH ITS THREADED TIP ALREADY STRIPPED. THE PATIENT HAD A SLIM NAIL IMPLANTED SEVERAL MONTHS AGO, AND THE PROCEDURE SCHEDULED WAS FOR ITS REMOVAL. HOWEVER, THE NONFUNCTIONAL DRIVER RENDERED THE STANDARD EXTRACTION TECHNIQUE UNUSABLE, RESULTING IN A SURGICAL DELAY OF MORE THAN 30 MINUTES. AN INTERNAL INVESTIGATION DETERMINED THAT THE AFFECTED SLIM DRIVER BELONGED TO AN INSTRUMENT RENTAL TRAY AND WAS ORIGINALLY MANUFACTURED IN (B)(6) 2018. A REVIEW OF COMPLAINT RECORDS REVEALED THAT THERE HAVE BEEN NO PRIOR COMPLAINTS RELATED TO THIS DRIVER. IT WAS CONCLUDED THAT THE THREAD STRIPPING OCCURRED DURING A PREVIOUS SURGERY AND WAS NOT IDENTIFIED DURING THE INCOMING INSPECTION AT THE DISTRIBUTOR'S FACILITY PRIOR TO REISSUING THE INSTRUMENT TRAY. NOTE: THIS MDR WAS ORIGINALLY SUBMITTED AS MFR #3000327-2024-00009 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 DRIVER WAS DELIVERED TO THE HOSPITAL WITH A STRIPPED THREADED TIP, MAKING IT IMPOSSIBLE FOR THE SURGEON TO REMOVE THE NAIL USING THE STANDARD EXTRACTION METHOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310132 SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM SLIM DRIVER FOR Ø2.0, 2.6 & 3.2 MM RODS HXX ORTHOPEDIATRICS CANADA ULC A012-01

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Female Other