BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUGGERKNOT 1.4MM 1 #1 MB 10PK

    MDR report key: 3994184 · Received August 8, 2014

    Report

    Report Number
    0001825034-2014-06937
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 28, 2014
    Report Date
    August 14, 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
    US
    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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER WARNING, NUMBER 9 STATES, "DO NOT USE EXCESSIVE FORCE WHEN INSERTING THE DEVICE. EXCESSIVE FORCE MAY CAUSE DAMAGE TO THE DEVICE AND/OR ADVERSELY AFFECT ITS PERFORMANCE." EVALUATION IN PROCESS BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA.

    Additional Manufacturer Narrative · 1

    EXAMINATION OF RETURNED DEVICE FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCE. THE ROOT CAUSE OF THE EVENT WAS NOTED TO BE DUE TO MISALIGNMENT. THE COMPONENT WAS DAMAGED IN AN EFFORT TO CORRECT THIS MISALIGNMENT WITH EXCESSIVE FORCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A SHOULDER REPAIR PROCEDURE ON (B)(6) 2014. WHILE SEATING THE SUTURE ANCHOR, THE METAL TIP OF THE SUTURE ANCHOR FRACTURED. THE FRACTURED TIP REMAINS IN THE PATIENT'S GLENOID BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467334 JUGGERKNOT 1.4MM 1 #1 MB 10PK FASTENER, FIXATION MBI BIOMET ORTHOPEDICS N/A 809220

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention