BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JGRKNT 1.0MM MINI 3-0 NDLS

    MDR report key: 3932538 · Received July 14, 2014

    Report

    Report Number
    0001825034-2014-06152
    Event Type
    Injury
    Date Received
    July 14, 2014
    Date of Event
    May 23, 2014
    Report Date
    June 19, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MBI
    PMA / PMN Number
    PK110879
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A SCAPULATE TENDON REPAIRMENT PROCEDURE ON (B)(6) 2014. DURING THE PROCEDURE, THE PLASTIC SHEATH STUCK PREVENTING THE IMPLANT FROM ADVANCING. ANOTHER JUGGERKNOT WAS UTILIZED TO COMPLETE THE PROCEDURE. ADDITIONALLY, RE-DRILLING OCCURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409922 JGRKNT 1.0MM MINI 3-0 NDLS FASTENER, FIXATION MBI BIOMET ORTHOPEDICS N/A 238340

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R