BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOBUTTON CL ULTRA, 15MM

    MDR report key: 4974598 · Received August 5, 2015

    Report

    Report Number
    1219602-2015-00732
    Event Type
    Injury
    Date Received
    August 5, 2015
    Date of Event
    September 12, 2014
    Report Date
    September 12, 2014
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    GAT
    PMA / PMN Number
    K980155
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT CANNOT BE CONFIRMED THAT THE BROKEN PIECE WAS REMOVED FROM THE OPERATIVE FIELD AND/OR RETRIEVED FROM THE PATIENT. THERE WERE NO X RAYS TAKEN TO CONFIRM RETRIEVAL. NO PRODUCT RETURNED FOR EVALUATION METHOD: PRODUCT NOT RETURNED FOR THE EVALUATION. EVALUATION WAS NOT POSSIBLE, AS THE DEVICE IS NOT BEING RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS WERE PERFORMED WHICH CONFIRMED NO INCONSISTENCIES. THERE WERE NO INTERNAL PROCESSING ISSUES, WHICH COULD HAVE CONTRIBUTED TO THE NATURE OF THE COMPLAINT. DUE TO THIS FACT 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

    IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT PROCEDURE, THE ENDOBUTTON IMPLANT BROKE DURING THE CASE WAS NEVER LOCATED. IT WAS NOT CONFIRMED IF THE FRAGMENT WAS RETRIEVED OR LOCATED. THE SURGEON USED A BACKUP DEVICE TO COMPLETE THE PROCEDURE, AN XTENDOBUTTON, AND NEW SUTURES WERE LOADED ONTO IT. IT WAS CONFIRMED THAT AN X-RAY WAS NOT USED. BOTH SUTURES BROKE AND THE CONTINUOUS LOOP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515356 ENDOBUTTON CL ULTRA, 15MM SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT SMITH & NEPHEW, INC. 50516383

    Patients

    Seq Age Sex Outcome Treatment
    1 Other