BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHAMPION SLIDER NEEDLE

    MDR report key: 3896245 · Received June 12, 2014

    Report

    Report Number
    8043971-2014-00001
    Event Type
    Injury
    Date Received
    June 12, 2014
    Report Date
    June 11, 2014
    Manufacturer
    T.A.G. MEDICAL PRODUCTS, CORP, LTD.
    Product Code
    HWQ
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DHR RECORDS WERE VERIFIED AND NO DISCREPANCY WAS RECORDED ON THESE ITEMS. RAW MATERIALS INSPECTION RECORDS WITH NO DISCREPANCY. (B)(4). CONCENTRICITY OF 1MM HOLE WAS FOUND WITHIN SPEC. NO OTHER DEFECTS WERE DETECTED. ACCORDING TO THE ATTACHED IMAGE THE FRACTURE WAS CAUSED DUE TO WRONG BENDING CONDITIONS AND EXTENSIVE EXTERNAL LOAD. THIS DEVICE INTENDED TO BE USED ON SOFT TISSUE AS STATED IN THE IFU. IN THE REPORT IT IS STATED THAT DEVICE WAS USED ON LABRUM AND THAT THE SURGEON LIKELY STRUCK BONE. THIS DEVICE IS NOT DESIGNED TO BE IN USE ON BONES. SEE THE FOLLOWING IN THE IFU 505ST - PARAGRAPH INDICATION AND PRECAUTIONS. THIS PRODUCT USE IS PASSING SUTURE TISSUE DURING MINIMALLY INVASIVE SURGERY. DO NOT APPLY EXCESSIVE AXIAL OR BENDING FORCE TO THE SLIDER NEEDLE DURING USE, AS EXCESSIVE FORCE MAY LIMIT THE FUNCTION OF THE DEVICE OR CAUSE THE DEVICE TO BEND, DEFORM OR BREAK.

    Description of Event or Problem · 1

    PHYSICIAN 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 PATIENT. THE SURGERY WAS PROLONGED FOR APPROXIMATELY 30-60MIN. THE SURGEON STATED HE WILL MOST LIKELY HAVE TO GO BACK IN FOR ANOTHER SURGERY AT A LATER DATE TO REMOVE THE BROKEN PART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348875 CHAMPION SLIDER NEEDLE NONE HWQ T.A.G. MEDICAL PRODUCTS, CORP, LTD. 3910-500-751 13F76

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Other