BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUGGERKNOT 1.5MM 1 #2 MB

    MDR report key: 3230221 · Received July 16, 2013

    Report

    Report Number
    0001825034-2013-02722
    Event Type
    Injury
    Date Received
    July 16, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 17, 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

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. 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." EVALUATION IN PROCESS BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA.

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE DEVICE FOUND THE FRACTURED TIP WAS BENT IN ONE DIRECTION CONSISTENT WITH THE EFFECT THAT THE GUIDE WAS MOVED DURING INSERTION AND THE TIP WAS NOW AT AN ANGLE AND BEING COMPRESSED. THEREFORE THE TIP FRACTURED DUE TO REPEATED 'TAPS' TO THE HANDLE INDICATING IMPROPER SURGICAL TECHNIQUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LABRAL REPAIR PROCEDURE, THE 1.5 JUGGERKNOT FRACTURED IN THE PATIENT'S BONE WHILE A MALLET WAS BEING USED TO INSERT THE IMPLANT. THE FRACTURED PIECE WAS REMOVED FROM THE PATIENT'S BONE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ADDITIONAL JUGGERKNOTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328562 JUGGERKNOT 1.5MM 1 #2 MB FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI BIOMET ORTHOPEDICS N/A 078590

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention