BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHROTEK, INC

    MDR report key: 914452 · Received September 13, 2007

    Report

    Report Number
    MW5003756
    Event Type
    Malfunction
    Date Received
    September 13, 2007
    Date of Event
    February 17, 2006
    Report Date
    September 13, 2007
    Manufacturer
    BIOMET
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    RECEIVED LETTER FROM MFR - BIOMET INC-ALERTING HOSP OF EVENT THAT OCCURRED. PHYSICIAN CONTACTED MFR TO REPORT THAT HE HAD REC'D NOTICE FROM PT'S ATTORNEY ALLEGING METAL FRAGMENTS WERE IDENTIFIED IN PT'S SHOULDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTHROTEK, INC LACTOSCREW LS ANCHOR 3.5MM HWC BIOMET 905493 940190
    2 ARTHROTEK, INC LACTOSCREW LS ANCHOR 3.5MM HWC BIOMET 905493 044880
    3 ARTHROTEK , INC LACTOSCREW LS ANCHOR 5.5 MM PR HWC BIOMET 905496 960560
    4 ARTHROTEK, INC DISP SUTURE LARIAT NBH BIOMET 904008 587310
    5 ARTHROTEK, INC DISPOSABLE CANNULA 7MMX75MM HRX BIOMET 900357 889200

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Other