BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUGGERKNOT 2.9 W/CUTTING ND

    MDR report key: 4151596 · Received October 8, 2014

    Report

    Report Number
    0001825034-2014-08023
    Event Type
    Injury
    Date Received
    October 8, 2014
    Date of Event
    September 17, 2014
    Report Date
    September 17, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MBI
    PMA / PMN Number
    PK110145
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A HAMSTRING REPAIR PROCEDURE UTILIZING SOFT ANCHORS ON (B)(6) 2014. DURING THE PROCEDURE, THE ANCHOR PULLED OUT AFTER THE SURGEON HAD IMPACTED IT. ANOTHER ANCHOR WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL HOLES WERE DRILLED AND THERE WAS NOT A DELAY AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633517 JUGGERKNOT 2.9 W/CUTTING ND FASTENER, FIXATION MBI BIOMET ORTHOPEDICS N/A 580230

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R