BEUDAMED
    FDA Adverse Event Other Summary report: N

    TORRINGTON DISPOSABLE STERILE STAINLESS STEEL SURGEONS' NEEDLES

    MDR report key: 2593057 · Received May 22, 2012

    Report

    Report Number
    MW5025541
    Event Type
    Other
    Date Received
    May 22, 2012
    Date of Event
    May 7, 2012
    Report Date
    May 22, 2012
    Manufacturer
    HOSPITAL MARKETING SERVICES, CO, INC.
    Product Code
    GAB
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SURGEON WAS PERFORMING AN OPEN REDIRECTION INTERNAL FIXATION OF LEFT PROXIMAL HUMEROUS, WHILE USING A 1/2 CIRCLE MAYO CATGUT TAPER POINT DISPOSABLE FREE SUTURE NEEDLE, THE EYELIT PART OF THE SUTURE NEEDLE BROKE OFF INSIDE PT'S LEFT ARM IN DEEP TISSUE. ATTEMPTS TO RETRIEVE BROKEN PART OF SUTURE, UNDER FLUOROSCOPY WAS UNSUCCESSFUL. SURGEON WAS CONCERNED THAT FURTHER ATTEMPTS WOULD POSSIBLY CAUSE HARM AND THAT BROKEN PIECE WHERE LOCATED WOULD CAUSE NO HARM TO PT. BROKEN PIECE WAS LEFT IN PT. PT AND FAMILY INFORMED BY SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TORRINGTON DISPOSABLE STERILE STAINLESS STEEL SURGEONS' NEEDLES MAYO CATGUT 1/2 CIRCLE TAPER POINT GAB HOSPITAL MARKETING SERVICES, CO, INC. 7-707-4 D67

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR