BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DJO SURGICAL

    MDR report key: 24808390 · Received April 7, 2026

    Report

    Report Number
    1644408-2026-00631
    Event Type
    Malfunction
    Date Received
    April 7, 2026
    Date of Event
    March 9, 2026
    Report Date
    May 13, 2026
    Manufacturer
    ENCORE MEDICAL L.P.
    Product Code
    LXH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A SUPPLEMENTAL REPORT TO THIS DOCUMENT AS SOON AS IT BECOMES AVAILABLE

    Description of Event or Problem · 0

    INSTRUMENT FAILURE - SURGEON PREPARING FEMORAL CANAL WITH ENOVIS DAA BINE RASP, AND THE TIP OF THE INSTRUMENT BROKE IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537051 DJO SURGICAL CURVED RASP LXH ENCORE MEDICAL L.P. 7950219

    Patients

    Seq Age Sex Outcome Treatment
    1