BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SUTURE

    MDR report key: 3812419 · Received May 15, 2014

    Report

    Report Number
    2210968-2014-06140
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 16, 2014
    Report Date
    April 23, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K032420
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: 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.

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE ACTUAL DEVICE INVOLVED IN THIS EVENT WAS RETURNED FOR EVALUATION. THE USED NEEDLE/SUTURE PIECE WAS VISUALLY EXAMINED FOR ATTRIBUTE DEFECTS UNDER MAGNIFICATION. SEVERE MARKS ON THE BODY AND THE TIP OF THE NEEDLE BY USE OF THE NEEDLE HOLDER WERE OBSERVED. THE SAMPLE CONDITION SUGGESTS IMPROPER HANDLING OF THE NEEDLE/SUTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A HIP SURGERY ON (B)(6) 2014 AND SUTURE WAS USED. WHILE USING THE SUTURE ON THE PATIENT, THE SURGEON NOTICED THE TIP BROKE AND MAY OR MAY NOT HAVE BROKEN OFF INTO THE PATIENT. X-RAYS WERE TAKEN WITH NO VISIBLE REMAINS. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291656 VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SUTURE SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. UNK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1