BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM

    MDR report key: 8647153 · Received May 28, 2019

    Report

    Report Number
    3000327445-2019-00001
    Event Type
    Malfunction
    Date Received
    May 28, 2019
    Date of Event
    May 3, 2019
    Report Date
    May 28, 2019
    Manufacturer
    PEGA MEDICAL, INC.
    Product Code
    HSB
    PMA / PMN Number
    K143355
    Removal / Correction Number
    3000327445-05/24/19-001R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE (I.H.) INDICATED THAT THE SURGEON WAS NOT ABLE TO DISASSEMBLE THE IMPLANT FROM THE INSTRUMENT AND THE SURGEON DECIDED TO USE ANOTHER SYSTEM FOR THAT PATIENT.

    Description of Event or Problem · 1

    THE SLIM HANDLE WAS JAMMED INTO THE SLIM DRIVER AND SLIM NAIL DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438911 SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM INTRAMEDULLARY NAIL HSB PEGA MEDICAL, INC. 150115-09

    Patients

    Seq Age Sex Outcome Treatment
    1