BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIMPLE LOCKING INTRA-MEDULLARY (SLIM) SYSTEM

    MDR report key: 7674357 · Received July 10, 2018

    Report

    Report Number
    3000327445-2018-00001
    Event Type
    Injury
    Date Received
    July 10, 2018
    Report Date
    March 15, 2018
    Manufacturer
    PEGA MEDICAL, INC.
    Product Code
    HSB
    PMA / PMN Number
    K143355
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SLIM ROD WAS INSERTED IN THE ULNA OF A (B)(6) PATIENT. NO INFORMATION WAS PROVIDED REGARDING THE DEVICE CATALOG NUMBER, THEREFORE THE DEVICE DIAMETER CANNOT BE DETERMINED AT THIS TIME. THE PATIENT'S HISTORY IS UNKNOWN, BUT IT APPEARS FROM THEIR X-RAY THAT THE BONE DEFECT IN THEIR ULNA IS RELATIVELY LARGE WITH COMPLETE BONE SEPARATION AND APPARENT NONUNION. IT IS LIKELY THAT THE LARGE BONE DEFECT CONTRIBUTED TO THE FATIGUE FAILURE OF THE EXPOSED SLIM ROD DUE TO CYCLIC CANTILEVER FORCES AT THE NONUNION SITE. BASED ON THE PATIENT'S X-RAY, THERE IS NO APPARENT PLASTIC DEFORMATION OF THE IMPLANT, FURTHER CONFIRMING ITS FATIGUE FAILURE. IT IS IMPORTANT TO NOTE THAT NONUNION IS PREVALENT IN THE FOREARM DUE TO THE DIFFICULTY IN MAINTAINING FULL IMMOBILITY. ARM MOVEMENT DURING NORMAL DAILY ACTIVITY EXPOSES THE HUMERUS AND FOREARM TO LARGE BENDING FORCES AS THEY ACT AS LEVERS. THEREFORE, IT IS OFTEN DIFFICULT TO ACHIEVE BONE UNION, ESPECIALLY WHEN THE BONE DEFECT IS LARGE, AS IN THIS CASE.

    Description of Event or Problem · 1

    A SLIM ROD THAT HAS BEEN INSERTED INTO THE ULNA OF A (B)(6) PATIENT BROKE AT THE NONUNION SITE, MIDWAY ALONG THE BONE SEGMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514929 SIMPLE LOCKING INTRA-MEDULLARY (SLIM) SYSTEM INTRAMEDULLARY NAIL HSB PEGA MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Required Intervention