BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STLESS STEEL 75CM 5 TR-55

    MDR report key: 7221860 · Received January 26, 2018

    Report

    Report Number
    2210968-2018-70469
    Event Type
    Malfunction
    Date Received
    January 26, 2018
    Date of Event
    January 10, 2018
    Report Date
    January 10, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAQ
    PMA / PMN Number
    K946173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT TO THE FDA: 1/25/2018. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DID THE NEEDLE FALL INTO THE PATIENT? WAS THE NEEDLE RETRIEVED IN THE SAME PROCEDURE? WAS ADDITIONAL TISSUE INCISION REQUIRED TO RETRIEVE THE NEEDLE? WHAT IS THE LOT NUMBER? ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Additional Manufacturer Narrative · 1

    PC-(B)(4). ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED:THE NEEDLE IN THE CASE WAS RETRIEVED WITHIN THE ORIGINAL PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A CARDIAC PROCEDURE ON (B)(6) 2018 AND SUTURE WAS USED. DURING STERNAL CLOSURE, THE NEEDLE ON THE STERNAL WIRE SNAPPED ALONG THE NEEDLE LINE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65808 STLESS STEEL 75CM 5 TR-55 SUTURE, NONABSORBABLE, STEEL GAQ ETHICON INC. JDJ149

    Patients

    Seq Age Sex Outcome Treatment
    1