BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUGGERKNOT 1.5MM 1 #2 MB

    MDR report key: 2933260 · Received January 29, 2013

    Report

    Report Number
    0001825034-2013-00174
    Event Type
    Injury
    Date Received
    January 29, 2013
    Date of Event
    December 28, 2012
    Report Date
    January 8, 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
    MA, 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 WARNINGS, NUMBER 2 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." THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-00173 / 00174).

    Additional Manufacturer Narrative · 1

    DIMENSIONAL EVALUATION FOUND COMPONENT TO BE WITHIN APPROPRIATE DESIGN SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A BANKART PROCEDURE UTILIZING ANCHORS ON (B)(6) 2012. DURING THE PROCEDURE, THREE ANCHORS WERE ATTEMPTED FOR IMPLANTATION AND ALL THREE PULLED OUT ONCE INSERTED INTO THE GLENOID. THE PROCEDURE WAS COMPLETED BY USING COMPETITOR ANCHORS. AS A RESULT, A DELAY GREATER THAN 30 MINUTES OCCURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39687 JUGGERKNOT 1.5MM 1 #2 MB FASTENER, FIXATION MBI BIOMET ORTHOPEDICS N/A 948840

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R