BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SUTURE

    MDR report key: 3923016 · Received July 9, 2014

    Report

    Report Number
    2210968-2014-08874
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 20, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K032420
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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

    A NEEDLE BROKEN IN THE BODY TOWARDS THE ATTACHMENT END WAS SUBMITTED FOR THIS EVALUATION. A VISUAL INSPECTION REVEALED SCUFF MARKS AND INDENTS AROUND THE BREAK AREA PRODUCED DURING HANDLING BY THE SURGICAL NEEDLE HOLDERS OR SOME OTHER GRIPPING DEVISE. THE NEEDLE FRACTURED DUE TO TENSILE OVERLOAD GENERATED DURING SEVERE MECHANICAL DEFORMATION WITH SIGNS OF DUCTILITY. THERE WERE NO SIGNS OF MANUFACTURING DEFECTS FOUND ON THE NEEDLE. IN ADDITION, 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 A PATIENT UNDERWENT AN OPEN REDUCTION, INTERNAL FIXATION OF THE ANKLE ON (B)(6) 2014 AND SUTURE WAS USED. WHEN THE SURGEON WAS SUTURING THROUGH THE ADIPOSE TISSUE, THE NEEDLE BROKE. THE BROKEN PIECE REMAINED IN THE SURGICAL FIELD AND WAS RETRIEVED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399395 VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SUTURE SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. UNK HC2179

    Patients

    Seq Age Sex Outcome Treatment
    1