BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASY-OUT, MICRO COMPRESSION FT

    MDR report key: 9606551 · Received January 20, 2020

    Report

    Report Number
    1220246-2020-01579
    Event Type
    Injury
    Date Received
    January 20, 2020
    Date of Event
    December 27, 2019
    Report Date
    January 20, 2020
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867263802
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP, THAT DURING A METATARSAL FRACTURE REPAIR PROCEDURE, THE SURGEON PREPARED THE INSERTION SITE USING A 2.2 DRILL, THE AR-8725-50H SCREW WAS INSERTED, AS THE SURGEON MADE THE FINAL TURNS, TO COUNTERSINK THE SCREW IT BROKE APPROXIMATELY 19-20 MM FROM THE DRIVE INSERTION POINT. THE SURGEON USED AN AR-8737-61, EASY OUT TOOL, ON POWER TO TRY AND RELEASE THE SCREW AND THE TIP OF THE DRIVER BROKE. THE PORTION OF THE SCREW WITH THE DRIVER INSERTION WAS REMOVED. THE REMAINDER OF THE SCREW WAS LEFT IN WITH THE TIP OF THE EASY OUT TOOL STILL IN THE CANNULATION OF THE SCREW. THE CASE WAS COMPLETED WITH THE REMAINDER OF THE SCREW STILL ACROSS THE FRACTURE SITE WITH THE FRACTURE REDUCED. ADDITIONAL INFORMATION OBTAINED 01/06/2020: THE SCREW BROKE BUT THE DRIVER FOR THE SCREW DID NOT BREAK. THE EXTRACTION TOOL BROKE LATER IN THE PROCEDURE. THE REMAINING 30MM OF THE SCREW WAS LEFT IN THE PATIENT, STILL ACROSS THE FRACTURE SITE, WITH THE TIP OF THE EASY OUT TOOL IN THE SCREW'S CANNULATION. THE SURGEON DID NOT NEED TO USE ANY ADDITIONAL SCREWS OR ADDITIONAL INCISIONS. IT WAS A METACARPAL FRACTURE AND THERE WERE LIMITED ACCESS POINTS. THE SURGEON DID NOT NEED TO DO ANYTHING ADDITIONAL THAT WAS UNPLANNED. THE FRACTURE WAS REDUCED BY THE REMAINING 30MM PIECE OF SCREW. THE ONLY ADDITIONAL PART OF THE PROCEDURE WAS THE ATTEMPTED UNSUCCESSFUL REMOVAL WITH THE EASY OUT TOOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71652 EASY-OUT, MICRO COMPRESSION FT ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ARTHREX, INC. EASY-OUT, MICRO COMPRESSION FT UNKNOWN 00888867263802

    Patients

    Seq Age Sex Outcome Treatment
    1 Other