BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGICAL STAINLESS STEEL SUTURE

    MDR report key: 1861285 · Received October 1, 2010

    Report

    Report Number
    2210968-2010-01254
    Event Type
    Malfunction
    Date Received
    October 1, 2010
    Date of Event
    August 31, 2010
    Report Date
    September 2, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    GAQ
    PMA / PMN Number
    K946173
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, ANY FURTHER INFO DERIVED FROM THE EVAL WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2010-01255. THE SAME PT IS REPRESENTED IN EACH MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A CORONARY ARTERY BYPASS GRAFT PROCEDURE ON (B)(6) 2010 AND SUTURE WAS USED TO CLOSE THE STERNUM. THE NEEDLE TIP BROKE AND THE SURGEON WAS UNABLE TO PASS THE NEEDLE THROUGH THE STERNUM. THE NEEDLE PIECES WERE REMOVED FROM THE PATIENT DURING THE SAME PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGICAL STAINLESS STEEL SUTURE SUTURE, NON-ABSORBABLE GAQ ETHICON, INC. NA V9002

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK