BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUGGERKNOT SINGLE LOADED SZ. 1

    MDR report key: 2202872 · Received August 11, 2011

    Report

    Report Number
    1825034-2011-00703
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 15, 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. 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 POSSIBLE ADVERSE EFFECTS, NUMBER TWO STATES, "BENDING OR FRACTURE OF THE IMPLANT." EVALUATION OF RETURNED DEVICE FOUND EVIDENCE OF USE ERROR. THIS REPORT SUBMITTED (B)(4), 2011.

    Additional Manufacturer Narrative · 1

    INFORMATION RECEIVED SUGGESTS THE INSERTER WAS PULLED BACK AND PUSHED FORWARD MULTIPLE TIMES WHICH COULD INCREASE THE LIKELIHOOD OF DAMAGING THE INSERTER TIP. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT SHOULDER PROCEDURE ON (B)(6), 2011. DURING THE PROCEDURE, THE SURGEON WAS ATTEMPTING TO INSERT A SUTURING DEVICE WHEN THE INSERTER FRACTURED. RADIOGRAPHS CONFIRMED THAT THE FRACTURED PORTION WAS NOT RETAINED BY THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JUGGERKNOT SINGLE LOADED SZ. 1 FASTENER, FIXATION MBI BIOMET SPORTS MEDICINE, INC. N/A 195250

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R| S