BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FASSIER-DUVAL IM TELESCOPIC SYSTEM

    MDR report key: 6157950 · Received December 9, 2016

    Report

    Report Number
    3000327445-2016-00002
    Event Type
    Malfunction
    Date Received
    December 9, 2016
    Report Date
    December 6, 2016
    Manufacturer
    PEGA MEDICAL, INC.
    Product Code
    HSB
    PMA / PMN Number
    041393
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DISTRIBUTOR INDICATED THAT THE KIT WAS OUT 50 TIMES SINCE COMMISSIONED IN FEBRUARY 2014. ON AT LEAST 3 OCCASIONS, THEY ARE AWARE THAT A 4.8 COIL PULLER SHAFT (AND MALE RETRIEVER TUBE 4.8MM) WAS USED. THE LAST HOSPITAL DID NOT USE THE 4.8 COIL PULLER AND THERE WERE NO OBVIOUS SIGNS OF THE CRACK IN THE PREVIOUS AFTER USE INSPECTION. THEREFORE, IT SEEMS THAT EITHER SOMETHING UNUSUAL OCCURRED AT THE LAST HOSPITAL OR THE CRACK WAS NOT DETECTED AT THE PREVIOUS INSPECTION. ADDITIONALLY, THE MANUFACTURING RECORDS FOR THE MALE RETRIEVER TUBE 4.8MM WERE REVIEWED AND ALL SPECIFICATIONS WERE FOUND WITHIN THE ACCEPTABLE LIMITS. NO CORRECTIVE ACTION WILL BE UNDERTAKEN AT THIS MOMENT SINCE THE ORIGIN OF THE FAILURE REMAINS UNCERTAIN AND THIS WAS THE FIRST TIME OCCURRENCE OF THIS TYPE OF FAILURE.

    Description of Event or Problem · 1

    THE 4.8MM MALE RETRIEVER TUBE BROKE AT THE TIP. A CRACK APPEARED AROUND THE NOTCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812514 FASSIER-DUVAL IM TELESCOPIC SYSTEM INTRAMEDULLARY NAIL HSB PEGA MEDICAL, INC. 111021-03

    Patients

    Seq Age Sex Outcome Treatment
    1