BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMITH & NEPHEW BIORCI DRIVER

    MDR report key: 303737 · Received November 2, 2000

    Report

    Report Number
    1219602-2000-00074
    Event Type
    Malfunction
    Date Received
    November 2, 2000
    Manufacturer
    SMITH & NEPHEW, INC./ENDOSCOPY DIVISION
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    S&N MEXICO REPORTED THAT A BIO-RCI SCREW DRIVER DID NOT FULLY INSERT INTO Q SCREWS. SURGEON ATTEMPTED TO INSERT A 7MM SMITH & NEPHEW BIO-RCI SCREW IN SPITE OF THE PROBLEM. A PORTION OF THE SCREW BROKE OFF DURING INSERTION. THE BORKEN PIECE WAS REMOVED AND THE SCREW LEFT IN THE SITE. NO PT INJURY WAS REPORTED AS A RESULT OF THIS SITUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMITH & NEPHEW BIORCI DRIVER SCREW DRIVER HXX SMITH & NEPHEW, INC./ENDOSCOPY DIVISION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN