BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUGGERKNOT 1.5MM 10 PACK

    MDR report key: 3203800 · Received July 3, 2013

    Report

    Report Number
    0001825034-2013-02467
    Event Type
    Injury
    Date Received
    July 3, 2013
    Date of Event
    May 29, 2013
    Report Date
    June 5, 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
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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, "DO NOT USE EXCESSIVE FORCE WHEN INSERTING THE DEVICE. EXCESSIVE FORCE MAY CAUSE DAMAGE TO THE DEVICE AND/OR ADVERSELY AFFECT ITS PERFORMANCE." AND "IMPROPER SELECTION, PLACEMENT, POSITIONING, AND FIXATION OF THE DEVICE CAN LEAD TO FAILURE OF THE DEVICE OR THE PROCEDURE." EVALUATION OF DEVICE FOUND EVIDENCE THAT FAILURE MODE WAS DUE TO TORSIONAL OVERLOAD OF THE INSERTER, CAUSING DEVICE TO FRACTURE AND SEVERING THE SUTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A SUPERIOR LABRAL TEAR FROM ANTERIOR TO POSTERIOR REPAIR PROCEDURE ON (B)(6) 2013. AFTER IMPLANTING THE JUGGERKNOT DEVICE THE SUTURE FRACTURED. THE DEVICE WAS REMOVED AND ANOTHER HOLE WAS DRILLED. AFTER IMPLANTING ANOTHER DEVICE THE IMPLANT PULLED OUT. ANOTHER JUGGERKNOT DEVICE WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304522 JUGGERKNOT 1.5MM 10 PACK FASTENER, FIXATION MBI BIOMET ORTHOPEDICS N/A 078480

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R