BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUTURELASSO, 25 DEGREE TIGHT CURVE LEFT

    MDR report key: 4861412 · Received June 23, 2015

    Report

    Report Number
    1220246-2015-00160
    Event Type
    Injury
    Date Received
    June 23, 2015
    Date of Event
    February 28, 2015
    Report Date
    June 1, 2015
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE CANNOT BE RETURNED FOR EVALUATION. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. IF THE DEVICE IS RETURNED AND ADDITIONAL INFORMATION IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. COMPLAINANT'S EVENT IS TYPICALLY CAUSED BY LEVERAGING AGAINST HARD BONE OR ANOTHER INSTRUMENT. THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS PART/LOT COMBINATION. FACILITY SOURCE UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A MONTHLY MAUDE REVIEW THAT WHEN USING AN ARTHREX SUTURELASSO TO PULL SUTURE DURING AN ARTHROSCOPIC LABRAL REPAIR, THE TIP BROKE OFF INTO THE DEEP SOFT TISSUE OUTSIDE OF THE SHOULDER CAPSULE. THE TIP WAS NOT RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405896 SUTURELASSO, 25 DEGREE TIGHT CURVE LEFT ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ARTHREX, INC. 430751602

    Patients

    Seq Age Sex Outcome Treatment
    1 Other