BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FASTPASS SCORPION SL-MF WITH FLUSHPORT

    MDR report key: 23806100 · Received December 15, 2025

    Report

    Report Number
    1220246-2025-05613
    Event Type
    Malfunction
    Date Received
    December 15, 2025
    Date of Event
    November 20, 2025
    Report Date
    February 11, 2026
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867293410
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, G3, H3, H6. THE REPORTED EVENT WAS CONFIRMED AS ONE UNPACKAGED AR-13999MFF, FASTPASS SCORPION SL-MF WITH FLUSHPORT, BATCH NUMBER 15318295, WAS RECEIVED FOR INVESTIGATION AND UPON VISUAL INSPECTION, IT WAS OBSERVED THAT THE JAW DOES NOT CLOSE COMPLETELY (SEE EVALUATION PICTURE 3). FUNCTIONAL TESTING WAS NOT PERFORMED DUE TO THE DAMAGE OF THE DEVICE. THE MOST LIKELY CAUSE OF THE REPORTED FAILURE IS WEAR AND TEAR OVER REPETITIVE USAGE. FURTHER VISUAL INSPECTION REVEALED THAT THE DEVICE SHOWS SIGNS OF METAL SURFACE OXIDATION (SEE EVALUATION PICTURES 4 - 6).

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    NO COMPLAINT ALLEGATION WAS PROVIDED. ALSO, THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. IT WILL BE PROCESSED AS REPAIR, NOT AS COMPLAINT. *** UPDATE 02-DEZ-2025 VBU: IT WAS REPORTED THAT THE DEVICE DOES NOT CLOSE ANYMORE. *** 12-DEC-2025 MAJUNG: FURTHER INFORMATION WAS RECEIVED: IT WAS REPORTED THAT DURING THE ROTATOR CUFF SURGERY, THE DEVICE DID NOT CLOSE ANYMORE. NO PARTS BROKE OFF THE DEVICE. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH USING A DIFFERENT DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272149 FASTPASS SCORPION SL-MF WITH FLUSHPORT ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. FASTPASS SCORPION SL-MF WITH FLUSHPORT 15318295 00888867293410

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown