BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUGGERKNOT LG SHANK BIT 1.4MM

    MDR report key: 3021528 · Received March 26, 2013

    Report

    Report Number
    0001825034-2013-00742
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    February 27, 2013
    Report Date
    February 27, 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
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF RETURNED DEVICE FOUND FRACTURE DUE TO INADVERTENT SURGICAL ERROR. 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, IT 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 LABRAL REPAIR PROCEDURE ON (B)(6) 2013. DURING THE PROCEDURE, THE DRILL WAS USED THROUGH THE CURVED GUIDE AND FRACTURED OFF INTO THE PATIENT'S GLENOID. THE PIECE WAS RETRIEVED WITH NO DELAY TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123479 JUGGERKNOT LG SHANK BIT 1.4MM FASTENER, FIXATION MBI BIOMET ORTHOPEDICS N/A 502630

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R