BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BILOK DRIVER

    MDR report key: 369169 · Received December 28, 2001

    Report

    Report Number
    MW1023718
    Event Type
    Injury
    Date Received
    December 28, 2001
    Date of Event
    December 5, 2001
    Report Date
    December 18, 2001
    Manufacturer
    BIOCOMPOSITES LTD
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING AN ACL PROCEDURE A SCREWDRIVER BENT. PROCEDURE WAS HAMSTRING AND A DILATOR WAS NOT USED CONTRARY TO MFR'S INSTRUCTIONS IN IFU. THERE WAS MINIMAL DELAY, SCREW WAS EVENTUALLY FULLY INSERTED AND SURGEON DEEMED GOOD GRAFT FIXATION WAS ACHIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58875 BILOK DRIVER ACL SCREWDRIVER HXX BIOCOMPOSITES LTD 150001 012

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention