BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SUTURE

    MDR report key: 3821384 · Received May 20, 2014

    Report

    Report Number
    2210968-2014-06372
    Event Type
    Injury
    Date Received
    May 20, 2014
    Date of Event
    May 2, 2014
    Report Date
    May 2, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K032420
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED HAS BEEN RECEIVED, HOWEVER, THE PRODUCT EVALUATION IS NOT YET COMPLETE. ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT A 5MM PORTION OF THE NEEDLE REMAINS IN THE ENDOPELVIC FASCIA. THE SURGEON OPINES THAT HE DOES NOT FEEL THERE WILL BE ANY LONG TERM CONSEQUENCES TO THE PATIENT. THERE ARE FURTHER PLANS FOR INTERVENTION AT THIS TIME. THE PATIENT HAS NOT HAD ANY CONSEQUENCES UP TO THIS POINT.

    Additional Manufacturer Narrative · 1

    CONCLUSION: A NEEDLE THAT BROKE IN THE BODY TOWARDS THE ATTACHMENT END WAS SUBMITTED FOR THIS EVALUATION. A MICROSCOPIC INSPECTION REVEALED INDENTS AND SCUFF MARKS AROUND THE BREAK AREA PRODUCED DURING HANDLING BY THE SURGICAL NEEDLE HOLDERS OR SOME OTHER GRIPPING DEVICE. THE NEEDLE FRACTURED DUE TO TENSILE OVERLOAD GENERATED DURING SEVERE MECHANICAL DEFORMATION, WITH SIGNS OF DUCTILITY. THERE ARE NO SIGNS OF MANUFACTURING DEFECTS FOUND ON THE NEEDLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ANTERIOR/POSTERIOR GYNECOLOGICAL REPAIR ON (B)(6) 2014 AND SUTURE WAS USED. WHILE PASSING THROUGH TISSUE, THE NEEDLE BROKE. THE SURGEON RETAINED A PART OF THE NEEDLE AND VERIFIED BY X-RAY THE REMAINDER WAS IN THE PATIENT¿S BODY. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300186 VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SUTURE SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. UNK GP2213

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other