BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS LL PLUS ANTIBACTERIAL SUTURE

    MDR report key: 3031343 · Received April 2, 2013

    Report

    Report Number
    2210968-2013-03296
    Event Type
    Injury
    Date Received
    April 2, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 12, 2013
    Manufacturer
    ETHICON, INC
    Product Code
    NEW
    PMA / PMN Number
    K061037
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    NURSE

    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): A NEEDLE THAT BROKE IN THE BODY IN TWO PLACES, THE PART OF THE NEEDLE BETWEEN THE POINT AND THE ATTACHMENT END WAS MISSING, 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 A PATIENT UNDERWENT A LAPAROSCOPIC HYSTERECTOMY PROCEDURE ON (B)(6) 2013 AND SUTURE WAS USED. WHILE THE SUTURE WAS BEING KNOTTED AT THE VAGINAL VAULT, THE NEEDLE BROKE INTO TWO PIECES. ONE BROKEN PIECE WAS LOST IN THE PATIENT'S TISSUE. WHEN THE DOCTOR TRIED TO REMOVE IT, IT BROKE INTO THREE NEW PIECES. ONE OF THOSE THREE FRAGMENTS WAS NOT FOUND. AN X-RAY WAS PERFORMED. APPROXIMATELY 3 MM OF NEEDLE WAS LOST INSIDE THE PATIENT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE ARE NO PLANS TO REMOVE THE NEEDLE FRAGMENT. CURRENTLY, THE PATIENT HAS HAD GOOD POSTOPERATIVE EVOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135014 PDS LL PLUS ANTIBACTERIAL SUTURE SUTURES, ABSORBABLE NEW ETHICON, INC NA EGZ149

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention