BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOMET SPORTS MEDICINE

    MDR report key: 1840011 · Received September 15, 2010

    Report

    Report Number
    MW5017440
    Event Type
    Malfunction
    Date Received
    September 15, 2010
    Date of Event
    August 16, 2010
    Report Date
    September 15, 2010
    Product Code
    MBI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT WAS UNDERGOING ARTHROSCOPIC ROTATOR CUFF REPAIR AND DURING THE PROCEDURE, AS THE SURGEON WAS TENSIONING THE CUFF THE ANCHOR BUCKLED AND BROKE AND DELAY IN THE PROCEDURE OF MORE THAN THIRTY MINUTES WAS REPORTED. DATES OF USE: (B)(6)2010. DIAGNOSIS OR REASON FOR USE: TORN ROTATOR CUFF. EVENT ABATED AFTER USE: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET SPORTS MEDICINE NONE MBI

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR