BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUREFIRE SCORPION

    MDR report key: 1124064 · Received August 8, 2008

    Report

    Report Number
    1124064
    Event Type
    Malfunction
    Date Received
    August 8, 2008
    Date of Event
    July 18, 2008
    Report Date
    August 8, 2008
    Manufacturer
    ARTHREX ARTHROSCOPY INSTRUMENTS, INC.
    Product Code
    MFJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT HAD AN MRI, WHICH SHOWED A COMPLETE ROTATOR CUFF TEAR. HE WAS ADMITTED TO THE HOSPITAL AND UNDERWENT A LEFT SHOULDER ARTHROSCOPIC SUBACROMIAL DECOMPRESSION, ACROMIOPLASTY, DISTAL CLAVICLE RESECTION, AND ROTATOR CUFF REPAIR. DURING THE REPAIR, TWO HORIZONTAL MATTRESS SUTURES AND TWO SIMPLE SUTURES WERE PLACED THROUGH THE CUFF WITH A SCORPION SUTURE PASSER. UPON COMPLETION OF THE LAST PASSAGE OF THE SUTURE THROUGH THE CUFF, IT WAS NOTED TO BE TOUGH AND DIFFICULT TO PASS THE SUTURE THROUGH THE SCORPION SUTURE PASSER. AS SOON AS IT WAS NOTICED TO BE TOUGH, THE SURGEON REMOVED THE PASSER AND NOTICED THAT THE LAST 1 TO 2 MM TIP OF THE NEEDLE WAS MISSING FROM THE SCORPION NEEDLE. IT WAS FOUND TO BE STUCK IN THE ROTATOR CUFF TISSUE. THE TIP HAS REMAINED IN THE PATIENT. IN ADDITION, THERE WAS ONE OTHER OCCURRENCE IN THE PAST WHERE THE TIP WAS FOUND AND REMOVED AFTER IT BROKE IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUREFIRE SCORPION NEEDLE, SUTURE, ENDOSCOPIC MFJ ARTHREX ARTHROSCOPY INSTRUMENTS, INC. AR13991N 170419

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR