BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGICAL STAINLESS STEEL SUTURE

    MDR report key: 1616576 · Received February 4, 2010

    Report

    Report Number
    2210968-2010-00098
    Event Type
    Malfunction
    Date Received
    February 4, 2010
    Report Date
    January 5, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    GAQ
    PMA / PMN Number
    K946173
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(4). NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFO 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 WHILE THE SURGEON WAS PERFORMING A STERNAL CLOSURE IN THE PT'S MANUBRIAL AREA AND ATTEMPTING TO PLACE A THROUGH-AND-THROUGH STERNAL WIRE THROUGH THE LEFT HALF OF THE DIVIDED STERNUM, THE NEEDLE HOLDING THE CLOSING WIRE FRACTURED. THERE WAS NO EVIDENCE OF A VISIBLE NEEDLE PROTRUDING ON, ABOVE, OR BELOW THE STERNUM. BECAUSE THE ARTERIAL GRAFTS WERE CLOSED AND NO NEEDLE WAS SEEN, IT WAS DETERMINED TO BE SAFEST TO LEAVE THE SOLIDLY IMBEDDED NEEDLE IN PLACE AND TO PROCEED WITH ANOTHER STERNAL WIRE TO SECURE CLOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGICAL STAINLESS STEEL SUTURE SUTURE, NONABSORBABLE GAQ ETHICON, INC. NA BMM107

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK