BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUGGERKNOT SINGLE LOADED SIZE 1

    MDR report key: 2211321 · Received August 15, 2011

    Report

    Report Number
    1825034-2011-00713
    Event Type
    Injury
    Date Received
    August 15, 2011
    Date of Event
    July 11, 2011
    Report Date
    July 20, 2011
    Manufacturer
    BIOMET SPORTS MEDICINE, INC.
    Product Code
    MBI
    PMA / PMN Number
    K071704
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. 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 PRECAUTIONS, IT STATES, "INSTRUMENTS ARE AVAILABLE TO AID IN THE ACCURATE IMPLANTATION OF INTERNAL FIXATION DEVICES. INTRAOPERATIVE FRACTURE OR BREAKING OF INSTRUMENTS HAS BEEN REPORTED". THIS IS MDR TWO OF TWO (1825034-2011-00712 THROUGH 00713) FOR THIS EVENT. THIS REPORT SUBMITTED (B)(4), 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT SHOULDER PROCEDURE ON (B)(6), 2011. DURING THE PROCEDURE, THE SURGEON HAD DIFFICULTIES INSERTING SOFT ANCHORS INTO THE GLENOHUMERAL JOINT. SUBSEQUENTLY, SURGEON NOTED THAT TWO INSERTERS HAD FRACTURED AT THE TIPS. POST-OPERATIVE RADIOGRAPHS CONFIRMED THAT THE FRACTURED TIPS OF THE INSERTERS HAD BEEN RETAINED IN THE PATIENT'S SHOULDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JUGGERKNOT SINGLE LOADED SIZE 1 FASTENER, FIXATION MBI BIOMET SPORTS MEDICINE, INC. N/A 132410

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R| S