BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCORPION

    MDR report key: 866101 · Received May 30, 2007

    Report

    Report Number
    866101
    Event Type
    Injury
    Date Received
    May 30, 2007
    Date of Event
    April 26, 2007
    Report Date
    May 30, 2007
    Manufacturer
    ARTHREX ARTHROSCOPY INSTRUMENTS, INC.
    Product Code
    GAB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS HAVING A ROTATOR CUFF REPAIR. NEAR THE END OF THE PROCEDURE, THE PHYSICIAN WAS USING A SCORPION ULTIMATE SUTURE PASSING DEVICE TO CLOSE THE SURGICAL SITE. AFTER THE PROCEDURE IT WAS NOTED THAT THE NEEDLE TIP HAD BROKEN OFF. THE PATIENT WAS LATER RETURNED TO SURGERY TO HAVE THE TIP REMOVED DUE TO PERSISTENT PAIN TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCORPION NEEDLE, SUTURE GAB ARTHREX ARTHROSCOPY INSTRUMENTS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other| R