BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOBUTTON CL ULTRA, 15MM

    MDR report key: 4929716 · Received July 21, 2015

    Report

    Report Number
    1219602-2015-00394
    Event Type
    Malfunction
    Date Received
    July 21, 2015
    Date of Event
    February 4, 2014
    Report Date
    July 21, 2015
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    GAT
    PMA / PMN Number
    K980155
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). EVALUATION WAS NOT POSSIBLE, AS THE DEVICE WILL NOT BE RETURNED. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED WHICH CONFIRMED NO INCONSISTENCIES. A COMPLAINT HISTORY REVIEW HAS NOT IDENTIFIED ADDITIONAL COMPLAINTS FOR THIS LOT NUMBER ON FILE. THERE WERE NO INTERNAL PROCESSING ISSUES WHICH COULD HAVE CONTRIBUTED TO THE NATURE OF THE COMPLAINT. DUE TO THESE FACTS WE ARE UNABLE TO DETERMINE WHAT MAY HAVE CAUSED THE USER TO EXPERIENCE THE REPORTED INCIDENT. NO FURTHER INVESTIGATION IS WARRANTED AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION UTILIZING THE ENDOBUTTON CL ULTRA, 15MM IT WAS REPORTED THE SUTURE BROKE. IT WAS REPORTED THAT THE BREAKAGE OCCURRED WITH THE WHITE LEAD SUTURE AT THE ENDOBUTTON HOLE WHILST PULLING THE GRAFT INTO THE FEMORAL SOCKET. THE GRAFT WAS 8.5MM. THE GRAFT WAS RETRIEVED, PASSED ARTHREX FIBREWIRE THROUGH AND RE-ATTEMPTED, WHICH ALSO SNAPPED. THE SURGEON ABANDONED AND USED RIGIDFIX. THE TUNNEL WAS REAMED TO 8.5MM AND THE LEAD SUTURE WAS BEING PULLED THROUGH WITH A CLIP. WHEN THE SUTURE SNAPPED THE SURGEON RE-REAMED, AGAIN WITH 8.5MM DRILL AND THAT IS WHEN HE TRIED THE FIBREWIRE, WHICH ALSO SNAPPED. THE SURGEON USED RIGIDFIX INSTEAD OF ENDOBUTTON TO COMPLETE SURGERY SO THE PATIENT HAD NO ADVERSE EFFECTS. NO PART OF THE DEVICE WAS LEFT IN THE PATIENT. THERE WAS A 20 MINUTE DELAY IN COMPLETING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473662 ENDOBUTTON CL ULTRA, 15MM SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT SMITH & NEPHEW, INC. 50486711

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR