BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FASSIER-DUVAL TELESCOPIC IM SYSTEM

    MDR report key: 23262106 · Received October 9, 2025

    Report

    Report Number
    3000327445-2024-00004
    Event Type
    Injury
    Date Received
    October 9, 2025
    Date of Event
    August 5, 2024
    Report Date
    October 9, 2025
    Manufacturer
    PEGA MEDICAL, INC.
    Product Code
    LXH
    PMA / PMN Number
    K041393
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE HOSPITAL REPRESENTATIVE REPORTED THAT DURING SURGERY, A COIL PULLER SHAFT BROKE, REQUIRING THE BONE TO BE OPENED TO RETRIEVE THE BROKEN PIECES. ALTHOUGH THE SURGERY WAS ULTIMATELY SUCCESSFUL, THIS COMPLICATION DELAYED THE PROCEDURE BY APPROXIMATELY ONE HOUR. THE FASSIER-DUVAL COIL PULLER SHAFT IS A RETRIEVAL INSTRUMENT USED TO EXTRACT IMPLANTS FROM BONE. IT IS USED IN COMBINATION WITH THE COIL PULLER TUBE AND EITHER THE MR200 OR MR300. BASED ON THE INFORMATION PROVIDED BY THE HOSPITAL REPRESENTATIVE, THE SURGEON ENCOUNTERED DIFFICULTIES DUE TO IMPROPER MANIPULATION OF THE MALE RETRIEVER HANDLE WITH THE MALE RETRIEVER AT THE POINT WHEN THE COIL PULLER ASSEMBLY WAS ALREADY ENGAGED WITH THE IMPLANT. ADDITIONAL MANIPULATIONS WITH THE MALE RETRIEVER WERE REQUIRED. IT IS LIKELY THAT DURING THESE MANIPULATIONS, THE COIL PULLER PARTIALLY DISENGAGED FROM THE IMPLANT. WHEN THE COIL PULLER SHAFT IS ONLY PARTIALLY ENGAGED OR COMPLETELY DISENGAGED, TIGHTENING THE MALE DRIVER HANDLE CAN CAUSE DAMAGE TO THE COIL PULLER SHAFT, RENDERING IT UNUSABLE. THESE FACTORS LIKELY CONTRIBUTED TO THE BREAKAGE, AS THE COIL PULLER IS INTEGRAL TO THE ASSEMBLY. NOTE: THIS MDR WAS ORIGINALLY SUBMITTED AS MFR # ON AUGUST 29, 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 HOSPITAL REPRESENTATIVE REPORTED THAT DURING SURGERY, A MALE RETRIEVER COIL BROKE AND NECESSITATED OPENING UP THE BONE TO RETRIEVE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2029653 FASSIER-DUVAL TELESCOPIC IM SYSTEM COIL PULLER SHAFT LXH PEGA MEDICAL, INC. E333-003

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Female Other