BEUDAMED
    FDA Adverse Event Other Summary report: N

    BANANA SUTURE LASSO

    MDR report key: 1353138 · Received March 30, 2009

    Report

    Report Number
    1220246-2009-00036
    Event Type
    Other
    Date Received
    March 30, 2009
    Date of Event
    July 27, 2006
    Report Date
    March 5, 2009
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS REQUESTED FOR EVAL, BUT WAS NOT RETURNED BECAUSE RISK MGMT. WILL NOT RELEASE THE DEVICE, THEREFORE THE COMPLAINANT'S EVENT COULD NOT BE VERIFIED. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFO AVAILABLE, AND WITHOUT DEVICE EVAL. LOT NUMBER WAS REQUESTED BUT NOT PROVIDED, THEREFORE DEVICE HISTORY RECORD REVIEW COULD NOT BE CONDUCTED. BASED ON THE INFO PROVIDED, THE MOST LIKELY CAUSE OF THIS TYPE OF EVENT IS LEVERAGING AGAINST HARD BONE OR ANOTHER INSTRUMENT. IF ADD'L RELEVANT INFO IS OBTAINED, A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE INSTRUMENT BROKE OFF IN THE PT'S SHOULDER WHEN SUTURING THROUGH THE CAPSULE AND LABRUM; IT WAS NOT RETRIEVED AFTER MULTIPLE ATTEMPTS. THERE WAS NO PT INJURY REPORTED; THE PT IS CURRENTLY REPORTED AS IN GOOD CONDITION. PROCEDURE: DIAGNOSTIC OPERATIVE ARTHROSCOPY BANKHART REPAIR AND CAPSULORRHAPHY. INSERTION SITE: RIGHT SHOULDER. NO FURTHER INFO WAS PROVIDED AT THE TIME OF THIS REPORT OR MADE AVAILABLE IN RESPONSE TO F/U COMMUNICATION. NO ADD'L ADVERSE CONSEQUENCES HAVE BEEN REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BANANA SUTURE LASSO LXH ARTHREX, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Other NO RELEVANT DATA PROVIDED.