BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA FAST-FIX ASSEMBLY - CURVED, EI

    MDR report key: 5845509 · Received August 3, 2016

    Report

    Report Number
    1219602-2016-00455
    Event Type
    Malfunction
    Date Received
    August 3, 2016
    Date of Event
    July 8, 2016
    Report Date
    July 8, 2016
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    GAT
    PMA / PMN Number
    K121861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION WAS NOT POSSIBLE, AS THE DEVICE WAS NOT RETURNED. THE INVESTIGATION WAS LIMITED TO THE INFORMATION PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED WHICH CONFIRMED NO INCONSISTENCIES. DEVICE AVAILABLE FOR EVALUATION: NO.

    Additional Manufacturer Narrative · 1

    (B)(6). NO EVALUATION CONDUCTED TO DATE, AWAITING RECEIPT OF DEVICE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A MENISCAL REPAIR PROCEDURE, THE T2 WOULD NOT DEPLOY. A BACKUP DEVICE WAS UTILIZED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497436 ULTRA FAST-FIX ASSEMBLY - CURVED, EI SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT SMITH & NEPHEW, INC. 50571592

    Patients

    Seq Age Sex Outcome Treatment
    1