BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUGGERKNOT 1.5MM 1 #2 MB

    MDR report key: 2943343 · Received February 5, 2013

    Report

    Report Number
    0001825034-2013-00230
    Event Type
    Injury
    Date Received
    February 5, 2013
    Date of Event
    November 15, 2012
    Report Date
    January 11, 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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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

    DIMENSIONAL EVALUATION FOUND COMPONENT TO BE WITHIN APPROPRIATE DESIGN SPECIFICATION. EXAMINATION OF RETURNED DEVICE WAS INCONCLUSIVE. 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."

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A LABRAL REPAIR ON HIP ON (B)(6) 2012. DURING THE PROCEDURE THE SURGEON INSERTED THE ANCHOR AND WHEN HE PULLED OUT THE INSERTER, ONE OF THE PONGS HAD FRACTURED OFF AT THE INSERTION SITE. THE SURGEON WAS ABLE TO REMOVE THE PIECE FROM THE PATIENT AND COMPLETE THE PROCEDURE UTILIZING ANOTHER ANCHOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48242 JUGGERKNOT 1.5MM 1 #2 MB FASTENER, FIXATION MBI BIOMET ORTHOPEDICS N/A 150050

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R