BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PICCOLO COMPOSITE HUMERAL NAIL

    MDR report key: 7005739 · Received November 7, 2017

    Report

    Report Number
    9615128-2017-00048
    Event Type
    Malfunction
    Date Received
    November 7, 2017
    Date of Event
    September 25, 2017
    Report Date
    November 7, 2017
    Manufacturer
    CARBOFIX ORTHOPEDICS LTD.
    Product Code
    HSB
    PMA / PMN Number
    K091425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCTION RECORDS OF THE NAIL DID NOT REVEAL DEVIATION FROM SPECIFICATION. THE INVOLVED NAIL WAS RECEIVED AND UNDERWENT EXAMINATION BY THE MANUFACTURER. ACCORDING TO THE FINDINGS, IT SEEMS THAT DURING NAIL INSERTION, EXCESSIVE FORCE WAS APPLIED ON THE PROXIMAL PART OF THE NAIL. IT SHOULD BE NOTED THAT IN CASES OF A DIFFICULT INSERTION, REAMING MAY BE PERFORMED TO FACILITATE THE INSERTION PROCESS.

    Description of Event or Problem · 1

    DURING ATTEMPT TO INSERT A PICCOLO COMPOSITE HUMERAL NAIL, THE THREAD AREA IN THE PROXIMAL PART OF THE NAIL (WHICH IS ATTACHED TO THE INSERTION HANDLE) WAS DAMAGED. THE NAIL WAS REMOVED AND REPLACED BY A LONGER CARBOFIX NAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787046 PICCOLO COMPOSITE HUMERAL NAIL INTRAMEDULLARY FIXATION ROD SYSTEM HSB CARBOFIX ORTHOPEDICS LTD. QTN04157

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR