BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUGGERKNOT 1.4MM SHRT W/NDLS

    MDR report key: 2943360 · Received February 5, 2013

    Report

    Report Number
    0001825034-2013-00220
    Event Type
    Injury
    Date Received
    February 5, 2013
    Date of Event
    January 10, 2013
    Report Date
    January 10, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MBI
    PMA / PMN Number
    PK110145
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DIMENSIONAL EVALUATION FOUND COMPONENT TO BE WITHIN APPROPRIATE DESIGN SPECIFICATION. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER WARNINGS, NUMBER 2 STATES, "IMPROPER SELECTION, PLACEMENT, POSITIONING, AND FIXATION OF THE DEVICE CAN LEAD TO FAILURE OF THE DEVICE OR THE PROCEDURE. THE SURGEON IS TO BE FAMILIAR WITH THE DEVICE, THE METHOD OF APPLICATION AND THE SURGICAL PROCEDURE PRIOR TO PERFORMING SURGERY. THE SURGEON MUST SELECT A TYPE OR TYPES OF INTERNAL FIXATION DEVICES APPROPRIATE FOR TREATMENT."

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A BROSTRUM ANKLE STABILIZATION PROCEDURE ON (B)(6) 2013. DURING THE PROCEDURE, THE ANCHOR JAMMED UPON INSERTION AND THE INSERTER BENT ON CONTACT WITH THE DRILLED HOLE. AS A RESULT, THE SURGEON HAD TO DRILL THREE MORE HOLES AND USE THREE ADDITIONAL JUGGERKNOTS TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48282 JUGGERKNOT 1.4MM SHRT W/NDLS FASTENER, FIXATION MBI BIOMET ORTHOPEDICS N/A 344410

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R