BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JUGGERKNOT 1.4MM SHORT W / NEEDLES

    MDR report key: 2272973 · Received October 3, 2011

    Report

    Report Number
    1825034-2011-00882
    Event Type
    Injury
    Date Received
    October 3, 2011
    Date of Event
    September 1, 2011
    Report Date
    September 8, 2011
    Manufacturer
    BIOMET SPORTS MEDICINE
    Product Code
    MBI
    PMA / PMN Number
    K110145
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. TWO LOT NUMBERS WERE REPORTED FOR THE PART NUMBER IDENTIFIED; IT IS NOT KNOWN WHICH LOT THE FRACTURED INSERTER IS FROM. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT BOTH LOTS RELEASED WITH NO RECORDED ANOMALY. LOT NUMBER AND EXPIRY DATE - TWO LOT NUMBERS REPORTED; LOT 384750 EXPIRY DATE FEBRUARY 28, 2016 & LOT 781540 EXPIRY DATE (B)(4) 2016. MANUFACTURE DATE - LOT 384750 MANUFACTURE DATE APRIL 8, 2011 & LOT 781540 MANUFACTURE DATE JUNE 24, 2011. THE USER FACILITY WAS NOTIFIED OF THE EVENT ON (B)(4) 2011. IN THE EVENT THAT THE USER FACILITY SUBMITS A MEDWATCH REPORT, BIOMET WILL FORWARD A COPY TO THE FDA. (B)(4).

    Additional Manufacturer Narrative · 1

    USER FACILITY FORWARDED A REPORT ON (B)(6), 2011. THIS FOLLOW-UP REPORT IS BEING FILED TO MAKE THE FDA AWARE THAT BOTH THE MANUFACTURER REPORT NUMBER AND USER FACILITY REPORT NUMBER REFERENCED IN THIS MEDWATCH ARE FOR THE SAME PATIENT, PART NUMBER, AND EVENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A PROCEDURE UTILIZING SOFT TISSUE ANCHORING DEVICES ON (B)(6) 2011. DURING THE PROCEDURE, A PORTION OF THE INSERTER OF THE DEVICE FRACTURED UPON INSERTION. THE ANCHOR FROM THE DEVICE WAS LOADED ONTO AN INSERTER PREVIOUSLY USED DURING THE PROCEDURE AND THE ANCHOR WAS IMPLANTED SUCCESSFULLY; HOWEVER, THE FRACTURED PIECE OF THE INSERTER WAS RETAINED BY THE PATIENT. MULTIPLE SOFT TISSUE ANCHORING DEVICES FROM TWO LOTS WERE UTILIZED DURING THIS PROCEDURE. IT IS NOT KNOWN WHICH LOT THE FRACTURED INSERTER IS FROM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JUGGERKNOT 1.4MM SHORT W / NEEDLES FASTENER, FIXATION MBI BIOMET SPORTS MEDICINE N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| S