BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOPAEDIC BIOSYSTEM LID

    MDR report key: 420745 · Received October 7, 2002

    Report

    Report Number
    420745
    Event Type
    Malfunction
    Date Received
    October 7, 2002
    Date of Event
    September 13, 2002
    Report Date
    September 24, 2002
    Manufacturer
    ORTHOPAEDIC BIOSYSTEMS
    Product Code
    KGS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING ROTATOR CUFF REPAIR USING 5.0MM OBC POLYMER SUTURE ANCHOR; ANCHOR TIP BROKE OFF IN SHAFT OF DRIVER. NO REMNANT OF SUTURE ANCHOR LEFT IN PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHOPAEDIC BIOSYSTEM LID POLYMER ANCHOR KGS ORTHOPAEDIC BIOSYSTEMS PRC5 Q2004D1

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR