BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUGGERKNOT 1.4MM 1 #1 MB 10PK

    MDR report key: 3915684 · Received July 7, 2014

    Report

    Report Number
    0001825034-2014-05952
    Event Type
    Injury
    Date Received
    July 7, 2014
    Date of Event
    June 9, 2014
    Report Date
    October 14, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MBI
    PMA / PMN Number
    PK071704
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF RETURNED DEVICE FOUND THE FORK TIP OF INSERTER TO BE BROKEN OFF AND MISSING. BASED ON THE REVIEW OF DEVICE HISTORY RECORDS AND ON THIS INVESTIGATION, THE PART LEFT BIOMET IN A CONFORMING TO PRINT SPECIFICATION CONDITION AND IT APPEARS THAT THE CONDITIONS OF USE CAUSED OR CONTRIBUTED TO THE INSERTER DAMAGE. THIS DEVICE REQUIRES PRECISE ALIGNMENT BEFORE IMPACTING FOR ANCHOR DEPLOYMENT, IF MISALIGNED INSERTER DAMAGE CAN OCCUR.

    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 LABRAL REPAIR PROCEDURE UTILIZING A SUTURE ANCHOR ON (B)(6) 2014. DURING THE PROCEDURE, A SUTURE ANCHOR APPEARED TO BE LOOSE UPON ATTEMPTED IMPLANTATION. ANOTHER SUTURE ANCHOR WAS USED TO COMPLETE THE PROCEDURE AND A NEW HOLE WAS DRILLED. THERE WAS NO SIGNIFICANT DELAY TO THE PROCEDURE AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393179 JUGGERKNOT 1.4MM 1 #1 MB 10PK FASTENER, FIXATION MBI BIOMET ORTHOPEDICS N/A 912460

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R