BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUROLON NYLON SUTURE

    MDR report key: 3981064 · Received August 5, 2014

    Report

    Report Number
    2210968-2014-10798
    Event Type
    Injury
    Date Received
    August 5, 2014
    Date of Event
    July 14, 2014
    Report Date
    July 17, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    GAR
    PMA / PMN Number
    K946173
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: ACTUAL SAMPLE WAS RETURNED FOR EVALUATION. VISUAL INSPECTION OF SAMPLE THAT BROKE AT THE TIP OF THE NEEDLE WAS PERFORMED. THE NEEDLE FRACTURED DUE TO TENSILE OVERLOAD GENERATED DURING SEVERE MECHANICAL DEFORMATION, WITH SIGNS OF DUCTILE FAILURE. THERE ARE NO SIGNS OF MANUFACTURING DEFECTS FOUND ON THE NEEDLE. THE DEVICE INFORMATION FOR USE CAUTIONS THE USER THAT "TO AVOID DAMAGING NEEDLE POINTS AND SWAGE AREAS, GRASP THE NEEDLE IN AN AREA ONE-THIRD (1/3) TO ONE-HALF (1/2) OF THE DISTANCE FROM THE SWAGED END TO THE POINT."

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE, THE DEVICE HAS NOT BEEN RETURNED. IF THE PRODUCT IS RETURNED FOR EVALUATION, ANY FURTHER INFO DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT BRAIN TUMOR RESECTION ON (B)(6) 2014 AND SUTURE WAS USED. THE PHYSICIAN WAS CLOSING THE CRANIUM AND ONE PASSAGE HAD BEEN MADE. WHEN MAKING A KNOTTED SUTURE, THE NEEDLE BROKE AT THE TIP. THE BROKEN TIP WAS NOT RETRIEVED AND THERE IS A POSSIBILITY IT REMAINS IN THE PATIENT¿S BODY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457362 NUROLON NYLON SUTURE SUTURE, NONABSORBABLE, SYNTHETIC GAR ETHICON INC. HDP106

    Patients

    Seq Age Sex Outcome Treatment
    1 Other