BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEX SCREWDRIVER

    MDR report key: 2240773 · Received September 1, 2011

    Report

    Report Number
    MW5022127
    Event Type
    Injury
    Date Received
    September 1, 2011
    Date of Event
    July 29, 2011
    Report Date
    September 1, 2011
    Manufacturer
    BIOMET SPORTS MEDICINE
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    REPORTED BY VENDOR BIOMET SPORT SOLUTIONS ON (B)(6) 2011 THAT AN INCIDENT OCCURRED IN THE OPERATING ROOM TO WHICH THEIR PRODUCT A HEX-SCREW BROKE DURING THE PROCEDURE AND THE SCREW WAS STRIPPED. THIS RESULTED IN THE NEED FOR RETRIEVAL OF THE BROKEN SCREWDRIVER AND AN ADDITIONAL 30 MINS OF OPERATING ROOM TIME TO THE PATIENT. VENDOR REP WAS IN THE OPERATING ROOM WHEN THIS OCCURRED. NOT CLEAR IF VENDOR RETRIEVED BROKEN SCREWDRIVER. REASON FOR USE: LEFT KNEE LIGAMENT RECONSTRUCTION AND PARTIAL LATERAL MENISCECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEX SCREWDRIVER CANNULATED HEX SCREWDRIVER 3.5MM HXX BIOMET SPORTS MEDICINE 676300

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Disability