BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8789601 · Received July 15, 2019

    Report

    Report Number
    1219602-2019-00813
    Event Type
    Malfunction
    Date Received
    July 15, 2019
    Date of Event
    June 26, 2019
    Report Date
    August 16, 2019
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    MBI
    UDI-DI
    03596010619068
    PMA / PMN Number
    K081511
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ONLY THE INSERTER FROM THE REPORTED DYNOMITE 2.0 PK W/NEEDLES WAS RETURNED FOR EVALUATION. VISUAL ASSESSMENT OF THE INSERTER SHOWED NO ABNORMALITIES. WITHOUT THE RETURN OF THE ANCHOR THE CUSTOMERS COMPLAINT CANNOT BE CONFIRMED. FROM THE INFORMATION PROVIDED, THE ANCHOR BROKE DURING INSERTION. AN EXACT ROOT CAUSE CANNOT BE DETERMINED WITH CONFIDENCE; HOWEVER, FACTORS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT INCLUDE: OFF AXIS INSERTION. NOT PREPARING THE INSERTION SITE WITH THE CORRECT INSTRUMENTATION. THE INSTRUCTION FOR USE WERE REVIEWED AND WERE FOUND TO OUTLINE PRECAUTIONARY STATEMENTS AND INSTRUCTIONS IN REGARDS TO THE USE OF THE DEVICE TO AVOID DAMAGE OR NON-FUNCTIONALITY. THERE WERE NO INDICATIONS THAT WOULD SUGGEST THAT THE DEVICE LOT DID NOT MEET PRODUCT SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INSERTION, THE ANCHOR BROKE. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO SIGNIFICANT DELAY OR PATIENT INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584908 DYNOMITE 2.0 PK W/NDL,1#2-0 ULTRABRAID FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI SMITH & NEPHEW, INC. 50778289 03596010619068

    Patients

    Seq Age Sex Outcome Treatment
    1