BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALL THREAD PEEK ANCHOR

    MDR report key: 1212470 · Received October 19, 2008

    Report

    Report Number
    1212470
    Event Type
    Malfunction
    Date Received
    October 19, 2008
    Date of Event
    October 2, 2008
    Report Date
    October 19, 2008
    Manufacturer
    BIOMET, INC.
    Product Code
    KGS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING THE SURGICAL PROCEDURE, OPEN ROTATOR CUFF REPAIR, SUTURE ANCHORS WERE INSERTED AND WHEN THE ORTHOPEDIC SURGEON ATTEMPTED TO RELEASE THE HANDLE FROM THE ANCHOR TO REMOVE THE INSERTER SHAFT IMPLANT WOULD NOT DISLODGE. THIS FAILED TWICE. PATIENT'S CARE WAS NOT COMPROMISED. HAND SUTURING WAS COMPLETED BY THE SURGEON DUE TO THE FAILURE. SALES REPRESENTTIVE WAS NOTIFIED OF THE PRODUCT FAILURE. LOT#306850. ACCORDING TO A BIOMET CORRESPONDENCE, THERE WAS A DELAY OF 20 MINUTES AND APPROXIMATELY 10MM OF BONE WAS REMOVED WHEN THE ANCHORS PULLED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALL THREAD PEEK ANCHOR SUTURE ANCHOR KGS BIOMET, INC. * 306850

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR