BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREE GLIDING SCFE SCREW SYSTEM

    MDR report key: 23262140 · Received October 9, 2025

    Report

    Report Number
    3000327445-2024-00006
    Event Type
    Injury
    Date Received
    October 9, 2025
    Date of Event
    February 10, 2024
    Report Date
    October 9, 2025
    Manufacturer
    PEGA MEDICAL INC
    Product Code
    HXX
    PMA / PMN Number
    K131591
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THAT THE INSTRUMENT LIKELY SUSTAINED DAMAGE DURING A PRIOR PROCEDURE, WHICH WENT UNNOTICED DUE TO INADEQUATE POST-OPERATIVE INSPECTION. THE DRIVER SHAFT IS DESIGNED TO OPERATE WITHOUT BENDING WHEN USED ACCORDING TO THE RECOMMENDED SURGICAL TECHNIQUES. HOWEVER, FAILURE TO DETECT DAMAGE FROM PRIOR USE MAY COMPROMISE THE INSTRUMENT'S STRUCTURAL INTEGRITY. TO MITIGATE SUCH RISKS, THOROUGH INSPECTION OF SURGICAL INSTRUMENTS AFTER EACH PROCEDURE IS CRITICAL FOR IDENTIFYING SIGNS OF WEAR OR DAMAGE TO ENSURE CONTINUED SAFE FUNCTIONALITY. ORTHOPEDIATRICS CANADA PROVIDES COMPREHENSIVE GUIDELINES FOR POST-SURGICAL INSTRUMENT INSPECTIONS, WHICH MUST BE CONSISTENTLY FOLLOWED TO PREVENT THESE INCIDENTS. ANOTHER POSSIBLE CONTRIBUTING FACTOR IS THE APPLICATION OF BENDING OR TORQUE FORCES EXCEEDING THE INSTRUMENT'S DESIGN SPECIFICATIONS. EXCESSIVE TORQUE CAN LEAD TO THE FAILURE OF THE THREADED TIP, RESULTING IN BREAKAGE. NOTE: THIS MDR WAS ORIGINALLY SUBMITTED AS MFR # ON NOVEMBER 26, 2024, BUT WAS REJECTED BY CDRH DUE TO AN INCORRECT FEI NUMBER IN THE ESUBMITTER FORM. IT IS NOW RESUBMITTED WITH THE CORRECT FEI (3000327445). CAPA INITIATED TO ADDRESS THE ISSUE.

    Description of Event or Problem · 0

    THE THREAD OF THE SCF-SFT365 SNAPPED OFF DURING INSERTION, LEAVING A FRAGMENT LODGED IN THE FEMALE COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1704290 FREE GLIDING SCFE SCREW SYSTEM SCFE DRIVER THREAD Ø6.5MM - STD HXX PEGA MEDICAL INC A183-03

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other