BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOMET

    MDR report key: 1686058 · Received May 11, 2010

    Report

    Report Number
    MW5015912
    Event Type
    Malfunction
    Date Received
    May 11, 2010
    Date of Event
    January 5, 2010
    Report Date
    May 4, 2010
    Manufacturer
    BIOMET
    Product Code
    MBI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT PROCEDURE UTILIZING A SUTURE ANCHOR ON (B) (6) 2010. DURING THE PROCEDURE, THE ANCHOR WAS DEPLOYED AND A PIECE OF THE WIRE REMAINED IN THE ANCHOR. THE SURGEON WAS ABLE TO RETRIEVE THE WIRE PIECE FROM THE ANCHOR. ANOTHER ANCHOR FROM THE SAME LOT WAS ATTEMPTED FOR USE WITH THE SAME RESULT. THERE WAS NO DELAY TO THE PROCEDURE OR INJURY TO THE PT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET ARTHROTEK 3.9 MICROMAX ANCHOR MBI BIOMET 905473 292280

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR