BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUTURELASSO, 45 DEGREE CURVE RIGHT

    MDR report key: 2072435 · Received April 29, 2011

    Report

    Report Number
    1220246-2011-00063
    Event Type
    Injury
    Date Received
    April 29, 2011
    Date of Event
    March 11, 2011
    Report Date
    April 4, 2011
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DEMOGRAPHICS (AGE AT TIME OF EVENT, DATE OF BIRTH, GENDER, WEIGHT) WERE REQUESTED BUT NOT PROVIDED. NO FURTHER PATIENT INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT OR MADE AVAILABLE IN RESPONSE TO FOLLOW-UP COMMUNICATION. NO ADDITIONAL ADVERSE CONSEQUENCES HAVE BEEN REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT. THE DEVICE WAS REQUESTED/IS EXPECTED FOR EVALUATION BUT HAS NOT YET BEEN RECEIVED. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. DEVICE HISTORY RECORD REVEALED NOTHING RELEVANT TO THIS EVENT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS TYPE OF EVENT AS DESCRIBED IN THE COMPLAINT IS TYPICALLY CAUSED BY LEVERAGING AGAINST HARD BONE OR ANOTHER INSTRUMENT. THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS PART/LOT COMBINATION. THE POTENTIAL CAUSES OF THIS EVENT ARE BEING COMMUNICATED TO THE EVENT REPORTER.

    Description of Event or Problem · 1

    DR WAS PERFORMING A RIGHT SHOULDER STABILIZATION UTILIZING THE 2.9MM PUSHLOCK AND SUTURE LASSO, A RIGHT 45 DEGREE LASSO WAS SELECTED , IT WAS NOT PASSING THROUGH THE LABRAL TISSUE AND IT WAS SUGGESTED THAT A 25 DEGREE LASSO MIGHT BE BETTER SUITED. A 25 DEGREE LASSO WAS OPENED. ON REMOVING THE 45 DEGREE LASSO IT WAS FOUND THAT THE TIP WAS MISSING LYING IN THE JOINT. DR THEN PROCEEDED TO REMOVE THE TIP WHICH CONSEQUENTLY GOT CAUGHT IN SOFT TISSUE. THE TIP BROKE OFF . DR THEN HAD TO OPEN THE PATIENT (PROCEDURE WAS REVERTED TO AN OPEN PROCEDURE TO FIND THE BROKEN PIECE) AND USE XRAY TO LOCATE THE TIP. THE TIP WAS LOCATED AND REMOVED. DR DECIDED TO ABANDON THE PROCEDURE AND BRING THE PATIENT BACK IN 5-6 WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUTURELASSO, 45 DEGREE CURVE RIGHT ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ARTHREX, INC. 009125245

    Patients

    Seq Age Sex Outcome Treatment
    1 Other