BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUGGERKNOT 1.4MM SHORT W/NDLS

    MDR report key: 2992923 · Received March 7, 2013

    Report

    Report Number
    0001825034-2013-00485
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    September 1, 2011
    Report Date
    February 6, 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
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP REPORT IS BEING SUBMITTED TO REPORT THIS IS A DUPLICATE. PLEASE REFER TO ORIGINAL MFR REPORT # 1825034-2011-00882.

    Additional Manufacturer Narrative · 1

    THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. EXPIRATION DATE & LOT NUMBER - IT IS UNKNOWN WHICH OF THE TWO LOTS IMPLANTED FRACTURED: 384750 OR 781540. MANUFACTURE DATE - IT IS UNKNOWN WHICH OF THE TWO LOTS IMPLANTED FRACTURED: 384750 OR 781540. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOTS RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 2 STATES, "BENDING OR FRACTURE OF THE IMPLANT."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ANTERIOR TALOFIBULAR LIGAMENT REATTACHMENT, POSTERIOR TIBIAL TENDON TRANSFER, THE FIRST TWO ANCHORS WERE IMPLANTED WITH NO REPORTED ISSUES. DURING THE INSERTION OF THE THIRD ANCHOR THE TIP OF THE INSERTER FRACTURED AND WAS UNABLE TO BE LOCATED. THE SURGEON RESET THE ANCHOR ON ONE OF THE PREVIOUSLY USED INSERTERS AND COMPLETED THE PROCEDURE WITHOUT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98209 JUGGERKNOT 1.4MM SHORT W/NDLS FASTENER, FIXATION MBI BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| R