BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COATED VICRYL (POLYGLACTIN 910) SUTURE

    MDR report key: 3072753 · Received April 23, 2013

    Report

    Report Number
    2210968-2013-04299
    Event Type
    Injury
    Date Received
    April 23, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 4, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    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 AND INDENTS 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. A VISUAL INSPECTION WAS ALSO PERFORMED ON ONE LOOSE NEEDLE RETURNED FOR EVALUATION. THE INSPECTION REVEALED THAT THE NEEDLE WAS STILL PARKED IN THE NEEDLE TRAY AND DOES NOT APPEAR TO HAVE BEEN USED. THERE WERE NO SIGNS OF MANUFACTURING DEFECTS FOUND ON THE NEEDLE.

    Additional Manufacturer Narrative · 1

    (B)(4). NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. 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 WAS SEEN ON (B)(6) 2012 FOR BLEEDING POST CONIZATION. THE SURGEON ATTEMPTED TO CONTROL THE BLEEDING BY SUTURING THE CERVICAL CANAL. WHILE SUTURING, THE NEEDLE TIP BROKE. THE PATIENT UNDERWENT A MRI AND CT SCAN TO LOCATE THE NEEDLE FRAGMENT. THE NEEDLE WAS VIZUALIZED ANTERIOR TO UTERINE CERVIX. THE SURGEON ELECTED NOT TO REMOVE THE FRAGMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175416 COATED VICRYL (POLYGLACTIN 910) SUTURE SUTURE, ABSORBABLE GAM ETHICON, INC. NA DD2911

    Patients

    Seq Age Sex Outcome Treatment
    1 Other