BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DYNOMITE 2.0 PK W/NDL,1#2-0 ULTRABRAID

    MDR report key: 5960942 · Received September 19, 2016

    Report

    Report Number
    1219602-2016-00691
    Event Type
    Malfunction
    Date Received
    September 19, 2016
    Date of Event
    January 8, 2013
    Report Date
    January 8, 2013
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    MBI
    PMA / PMN Number
    K081511
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL INSPECTION WAS PERFORMED ON THE ANCHOR. IT IS BROKEN AT THE DISTAL END CONFIRMING THE COMPLAINT. THE ANCHOR IS DISTORTED AT THE INTERFACE OF THE INSERTER WHICH IS INDICATIVE OF HIGH RESISTANCE DURING INSERTION. A REVIEW OF THE DEVICE HISTORY RECORDS AND QUALITY RECORDS ASSOCIATED WITH THIS MANUFACTURED LOT CONFIRMED THAT NO ADDITIONAL COMPLAINTS HAVE BEEN FILED AND THAT NO ABNORMALITIES WERE REPORTED WITH THIS PRODUCT DURING MANUFACTURE. THERE ARE NO INDICATIONS THAT WOULD SUGGEST THE DEVICE DID NOT MEET PRODUCT SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF A DYNOMITE 2.0 PK W/ ULTRABRAID BROKE. WHEN THE PACKAGE WAS OPENED THE ANCHOR FELL OFF THE INSERTER. THE DEVICE WAS REASSEMBLED AND THE HOLE WAS DRILLED. A BACKUP DEVICE WAS AVAILABLE FOR USE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611661 DYNOMITE 2.0 PK W/NDL,1#2-0 ULTRABRAID FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI SMITH & NEPHEW, INC. 50390948

    Patients

    Seq Age Sex Outcome Treatment
    1