BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHREX

    MDR report key: 1951934 · Received January 3, 2011

    Report

    Report Number
    MW5018865
    Event Type
    Malfunction
    Date Received
    January 3, 2011
    Report Date
    January 3, 2011
    Manufacturer
    ARTHREX INC
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    NUMBER OF PTS AFFECTED: UNK. NAME OF EQUIPMENT: DRIVER FOR 10 MM BIO-TENODESIS SCREW AR-1540DB, DRIVER FOR 12 MM BIO-TENODESIS SCREW AR-1670DB, DRIVER FOR 15 MM BIO-TENODESIS SCREW AR-1350D, DRIVER FOR 23 MM BIO-TENODESIS SCREW AR-1570DB. TYPE OF EQUIPMENT: ARTHREX DRIVERS FOR TENODESIS SCREWS. COMMON DEVICE NAME: TENODESIS SCREW DRIVER. (B)(4). MODEL & LOT #S: MODEL # AR-1540DB LOT# - 02064007. MODEL # AR-1350D LOT# -02063912. MODEL # AR-1670DB LOT# -02081910. MODEL # AR-1570DB LOT# -02063611-. NUMBER OF PTS WHO USED EQUIP: UNK. INDICATIONS FOR USE: BIOTENODESIS REPAIRS. DESCRIPTION OF EVENTS, PROBLEMS, OR PRODUCT USE ERRORS: UNABLE TO ENSURE THAT INSTRUMENTS ARE CLEAN. INSTRUMENT IS CANNULATED AND DOES NOT COME APART FOR CLEANING. THERE IS NO WAY TO ENSURE INNER CANNULA IS CLEAN OR STERILE. WE HAVE HAD TWO SEPARATE EVENTS WHERE THE INSTRUMENT HAS OLD DRY BLOOD COME OUT OF THE INSIDE OF THE CANNULA AFTER BEING CLEANED AND STERILIZED. THIS IS A VERY SERIOUS SAFETY/INFECTION CONTROL ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTHREX TENODESIS SCREW DRIVER HWC ARTHREX INC AR-1540DB 02064007
    2 ARTHREX TENODESIS SCREW DRIVER HWC ARTHREX INC AR-1350D 02063912
    3 ARTHREX TENODESIS SCREW DRIVER HWC ARTHREX INC AR-1670DB 02081910
    4 ARTHREX TENODESIS SCREW DRIVER HWC ARTHREX INC AR-1570DB 02063611

    Patients

    Seq Age Sex Outcome Treatment
    1 Other