BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSULECLOSE SCORPION

    MDR report key: 12231919 · Received July 27, 2021

    Report

    Report Number
    1220246-2021-03447
    Event Type
    Malfunction
    Date Received
    July 27, 2021
    Date of Event
    July 9, 2021
    Report Date
    October 1, 2021
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867212688
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION, HOWEVER PICTURES OF THE COMPLAINT DEVICE WERE PROVIDED. REVIEW OF THE PICTURES SHOWS THAT THE CAPSULECLOSE SCROPION SUTURE CLIP SPRING (PART NUMBER 910-021), 2.75MM SHEAR PIN (PART NUMBER 118-204) AND CAPSULECLOSE SCORPION SUTURE CLIP (PART NUMBER 910-019) BROKE OFF THE DISTAL END OF THE DEVICE. AS THE DEVICE WAS NOT RETURNED FOR INVESTIGATION, THE CAUSE OF THE BREAKAGE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HIP ARTHROSCOPIC PROCEDURE, WHEN THE SURGEON WAS ATTEMPTING TO PASS A #2 FIBERWIRE WITH THE CAPSULE CLOSE SCORPION, AR-16992, THE TIP OF THE INSTRUMENT BROKE INTO 3 PIECES IN THE JOINT. THE SURGEON WAS ABLE TO RETRIEVE THE 3 BROKEN PIECES FROM THE JOINT AND FOLLOW UP X-RAYS WERE TAKEN TO ENSURE NOTHING WAS MISSED. THE CASE WAS COMPLETED BY USING ANOTHER SCORPION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1132806 CAPSULECLOSE SCORPION ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ARTHREX, INC. CAPSULECLOSE SCORPION 00888867212688

    Patients

    Seq Age Sex Outcome Treatment
    1