BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHAMPION SUTURE SLIDER

    MDR report key: 3855851 · Received May 1, 2014

    Report

    Report Number
    2249697-2014-00007
    Event Type
    Injury
    Date Received
    May 1, 2014
    Date of Event
    April 2, 2014
    Report Date
    April 30, 2014
    Manufacturer
    T.A.G. MEDICAL PRODUCTS CORP. LTD
    Product Code
    HWQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DOCTOR WAS USING CHAMPION SLIDER TO TAKE BITE OF LABRUM TO PASS THE SUTURE THROUGH AND BROKE PART OF THE SLIDER NEEDLE OFF IN THE JOINT. HE THEN TRIED TO LOCATE THE BROKEN PIECE AND REMOVE IT FROM INSIDE THE JOINT BUT WAS UNABLE TO . IT REMAINED IN THE PT. SURGERY WAS PROLONGED FOR APPROXIMATELY 30-60MIN. THE BROKEN PART OF THE DEVICE WAS LEFT INSIDE THE PT'S JOINT. SURGEON STATED THAT HE WILL MOST LIKELY HAVE TO GO BACK IN FOR ANOTHER SURGERY AT A LATER DATE TO REMOVE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262001 CHAMPION SUTURE SLIDER PASSER HWQ T.A.G. MEDICAL PRODUCTS CORP. LTD 13F76

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Other