BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOMET JUGGERKNOT SOFT ANCHOR

    MDR report key: 1882008 · Received October 19, 2010

    Report

    Report Number
    MW5017888
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    September 30, 2010
    Report Date
    October 19, 2010
    Manufacturer
    BIOMET SPORTS MEDICINE LLC
    Product Code
    MBI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AK, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    RT SHOULDER/BICEP RUPTURE ANCHOR INSERTION. AFTER ARTHROSCOPIC INSERTION, IT WAS DISCOVERED THAT THE ANCHOR INSERTION GUIDE HAD BROKEN AT THE TIP, PRESUMABLY LEAVING A SMALL [3MM] PORTION, IN THE BONE. MFR'S INSTRUCTIONS ON INSERTIONS WERE CAREFULLY FOLLOWED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET JUGGERKNOT SOFT ANCHOR BONE ANCHOR MBI BIOMET SPORTS MEDICINE LLC 313660

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other