BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXIS ET PECA

    MDR report key: 24158853 · Received January 23, 2026

    Report

    Report Number
    3010673777-2025-00051
    Event Type
    Malfunction
    Date Received
    January 23, 2026
    Date of Event
    December 18, 2025
    Report Date
    January 23, 2026
    Manufacturer
    NOVASTEP SAS
    Product Code
    HWC
    PMA / PMN Number
    K143229
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AT THE END OF A HALLUX VALGUS PROCEDURE, A METAL STRING WAS FOUND ON THE PATIENT'S FOOT DURING ITS CLEANING. THE CLEANING WAS CARRIED OUT MORE INTENSIVELY THAN USUAL BECAUSE OF THIS. ON (B)(6) 2026: IT HAS BEEN CONFIRMED THAT THERE ARE TWO DIFFERENT METAL STRINGS ONE AS DESCRIBED AT FIRST. AFTER RECEIVING THE PARTS AND ANALYSING THEM INTERNALY THIS IS THE CONCLUSION WE CAN PROVIDE: THE ISSUE INVOLVES MACHINING DEBRIS. THE SUPPLIER HAS BEEN CONTACTED AND RECEIVED PHOTOS OF THE FRAGMENTS; THE THREADS WILL BE SENT TO THE SUPPLIER FOR FURTHER ANALYSIS. THE PRESENCE OF THESE DEBRIS CAN BE RELATE TO THE PRESENCE OF THE FRAGMENTS ON THE SCREW, OR IN THE PACKAGING OF THE SCREW, OR THE FRAGMENT WAS ALREADY PRESENT IN THE SURGICAL ENVIRONMENT. THE BATCHES INVOLVED IN THIS CASE ARE PARTIALLY CONSUMMED BY OTHER USERS AND WE HAVE RECEIVED 0 COMPLAINTS REGARDING THEM. NOTE: THIS IS AN ISOLATED CASE.

    Description of Event or Problem · 0

    AT THE END OF A HALLUX VALGUS PROCEDURE, A METAL STRING WAS FOUND ON THE PATIENT'S FOOT DURING ITS CLEANING. THE CLEANING WAS CARRIED OUT MORE INTENSIVELY THAN USUAL BECAUSE OF THIS. THE METAL STRING IS AVAILABLE FOR INSPECTION. IT HAS BEEN CONFIRMED THEN THAT THERE ARE TWO DIFFERENT METAL STRINGS NOT ONLY ONE AS DESCRIBED AT FIRST. FOR CLARIFICATIONS, BOTH OF THE PRODUCTS LISTED BELOW ARE SUSPECTED TO BE INVOLVED IN THIS CASE, AND WE CANNOT CONFIRM FROM WHICH IMPLANT THE FRAGMENTS CAME OUT, PS020028 : PECA 3 SCREW LG 28 / UDI : (B)(4) / BATCH N° L19606 / EXPIRATION DATE: 2029-08-01, SC020024: NEXIS 2.9 SCREW LG 24 / UDI : (B)(4) / BATCH N° M26074 / EXPIRATION DATE : 2030-06-01. THESE ELEMENTS HAVE BEEN ADDED HERE BEACAUSE THE TEMPLATE DOES NOT ALLOW US TO HAVE MULTIPLE IMPLANTS AS AN INPUT, WHILE TSWO IMPLANTS ARE SUSPECTED IN THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220508 NEXIS ET PECA NEXIS 2.9 SCREW LG 24 OR PECA 3 SCREW LG 28 HWC NOVASTEP SAS PS020028 OR SC020024 L19606 OR M26074

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other