BEUDAMED
    FDA Adverse Event Summary report: N

    ARTHREX SPEEDBRIDGE IMPLANT SYSTEM

    MDR report key: 3060174 · Received April 10, 2013

    Report

    Report Number
    MW5029745
    Date Received
    April 10, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 10, 2013
    Manufacturer
    ARTHREX
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    SHOULDER ROTATOR CUFF REPAIR. ARTHREX SPEEDBRIDGE IMPLANT SYSTEM USED FOR ANCHORS. ANCHOR PUT IN PLACE, METAL TIP WAS LEFT IN PT. C ARM CALLED IN TO ASSIST REMOVAL OF METAL TIP. FLOOR WAS CHECKED. C ARM SHOWED METAL TIP INSIDE PT. CONVERTED TO OPEN SHOULDER AND REMOVED METAL TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150243 ARTHREX SPEEDBRIDGE IMPLANT SYSTEM SPEEDBRIDGE IMPLANT SYSTEM HWC ARTHREX AR-2600SBS-5 569075

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention