BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSULECLOSE SCORPION

    MDR report key: 11990327 · Received June 14, 2021

    Report

    Report Number
    1220246-2021-03247
    Event Type
    Malfunction
    Date Received
    June 14, 2021
    Date of Event
    May 24, 2021
    Report Date
    August 4, 2021
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867212688
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT CONFIRMED. ONE UNPACKAGED AR-16992, BATCH 80163 CAPSULECLOSE SCORPION WAS RECEIVED FOR INVESTIGATION. VISUAL INSPECTION IDENTIFIED THAT THE 118-204 SHEAR PIN, 910-019 SUTURE CLIP, AND THE 910-021 SUTURE CLIP SPRING COMPONENTS HAD BROKEN OFF OF THE DISTAL TIP OF THE SCORPION. THE FRAGMENTS GENERATED DURING THIS EVENT WERE NOT RETURNED FOR ANALYSIS. FUNCTIONAL TESTING REVEALED THAT SQUEEZING THE FINGER ALLOWED THE TISSUE CLAMP ASSEMBLY TO ADVANCE AS INTENDED, ALTHOUGH USABILITY WAS IMPEDED BY THE LACK OF TIP COMPONENTS PRESENT. HEAVY DISCOLORATION, OXIDATION, AND GENERAL WEAR WAS NOTED ACROSS THE ENTIRETY OF THE DEVICE. THIS IS CONSISTENT WITH THE AGE OF THE DEVICE. THE PRECISE CAUSE OF THE EVENT REMAINS UNDETERMINED. PROBABLE CAUSES INCLUDE USER APPLIED MECHANICAL DAMAGE TO THE DISTAL END OF THE DEVICE, AND/OR WEAR AND TEAR DAMAGE INCURRED OVER YEARS OF REPEATED USAGE BASED ON THE MANUFACTURE DATE, LEADING TO THE EVENTUAL BREAKAGE EXPERIENCED.

    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 DURING A HIP PROCEDURE, AFTER INSERTION THE TIP OF THE AR-16992, SCORPION BROKE OFF. THE SURGEON USED GRASPERS TO REMOVE THE BROKEN PIECE. THE CASE WAS COMPLETED USING A COMPETITOR PRODUCT. THE INCIDENT ADDED 15 MINUTES TO THE PROCEDURE REQUIRING ADDITIONAL ANESTHESIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    893106 CAPSULECLOSE SCORPION ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ARTHREX, INC. CAPSULECLOSE SCORPION 80163 00888867212688

    Patients

    Seq Age Sex Outcome Treatment
    1