BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AOS SMALL BONE NAILING SYSTEM

    MDR report key: 9158835 · Received October 4, 2019

    Report

    Report Number
    2032480-2019-00013
    Event Type
    Injury
    Date Received
    October 4, 2019
    Date of Event
    September 7, 2019
    Report Date
    September 30, 2019
    Manufacturer
    ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
    Product Code
    HSB
    UDI-DI
    00848665028850
    PMA / PMN Number
    K163014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) A SURGERY TOOK PLACE FOR THE IMPLANT OF A FIBULAR NAIL P/N 1527-225. THE SALES REPRESENTATIVE REPORTED THAT DURING THE ROUTINE REAMING OF THE FIBULA, THE 3.1 MM SMALL BONE REAMER HEAD FRACTURED INTO MULTIPLE PIECES (P/N 4020-031). ALL BUT ONE PIECE WAS ABLE TO BE RETRIEVED. THE REMAINING PIECE WAS LODGED IN CORTICAL BONE, AND THE SURGEON DETERMINED THAT RETRIEVAL OF THE REMAINING PIECE WOULD CAUSE MORE DAMAGE THAN GOOD TO THE PATIENT. THOUGH THE LOT NUMBER WAS RETRIEVED FROM THE BROKEN REAMER, THE PARTS WERE NOT ABLE TO BE RETURNED FOR EVALUATION. THE PARTS WERE DISPOSED OF IMMEDIATELY AFTER THE SURGERY. AN ENGINEERING EVALUATION WAS UNABLE TO REPEAT THE FAILURE AS DESCRIBED, AND AN EXACT ROOT CAUSE IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    949757 AOS SMALL BONE NAILING SYSTEM INTERMEDULLARY FIXATION ROD HSB ADVANCED ORTHOPAEDIC SOLUTIONS, INC. 4020-031 171150 00848665028850

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Other