BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COATED VICRYL (POLYGLACTIN 910) SUTURE

    MDR report key: 2971593 · Received February 21, 2013

    Report

    Report Number
    2210968-2013-01325
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    January 25, 2013
    Report Date
    January 28, 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

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN EPISIOTOMY REPAIR ON (B)(6) 2013 AND SUTURE WAS USED. WHILE PASSING THE SUTURE THROUGH THE TISSUE, THE NEEDLE BROKE CLOSE THE SWAGE. THE SURGEON RE-OPENED THE PERINEUM AND PERFORMED BIMANUAL EXAMINATION BUT IT WAS NOT FOUND. THEN THE PATIENT UNDERWENT X-RAY BUT THE NEEDLE WAS NOT VISUALIZED. ON (B)(6) 2013, THE PATIENT UNDERWENT A SECOND X-RAY AND THE NEEDLE WAS VISUALIZED IN THE PERINEUM. THE PATIENT REQUIRED A RE-OPERATION TO REMOVE THE NEEDLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76386 COATED VICRYL (POLYGLACTIN 910) SUTURE SUTURE, ABSORBABLE GAM ETHICON, INC. NA BG2356

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention