BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIOMET

    MDR report key: 328774 · Received April 20, 2001

    Report

    Report Number
    328774
    Event Type
    Other
    Date Received
    April 20, 2001
    Date of Event
    April 5, 2001
    Report Date
    April 18, 2001
    Manufacturer
    BIOMET INC
    Product Code
    JDR
    Report Source
    User Facility report
    Reporter Location
    NV, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING UTILIZATION OF THE SUTURE ANCHORS, MULTIPLE SUTURES FRACTURED UPON INSERTION AND WERE REMOVED FROM THE FIELD. DURING PLACEMENT OF THE NEXT SUTURE ANCHOR A PORTION OF THE INSERTOR TIP BROKE OFF WITHIN THE IMPLANT AND WAS NOT RETRIEVABLE FROM THE PT'S SHOULDER. NO ADD'L INTERVENTION ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18117 BIOMET BIOPHASE II SUTURE ANCHOR 3MM JDR BIOMET INC BIOPHASE SUTURE ANCHOR 330720

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other