BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALKYRIE® - POWER DRIVER

    MDR report key: 24218420 · Received January 29, 2026

    Report

    Report Number
    3004049923-2026-00001
    Event Type
    Malfunction
    Date Received
    January 29, 2026
    Report Date
    January 29, 2026
    Manufacturer
    JEIL MEDICAL CORPORATION
    Product Code
    KIJ
    UDI-DI
    08806390899796
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE MALFUNCTION WAS REPORTED IN WHICH THE DEVICE DID NOT PERFORM AS INTENDED. NO CLINICAL SIGNS OR SYMPTOMS WERE REPORTED, AND THERE WERE NO HEALTH CONSEQUENCES ASSOCIATED WITH THE EVENT. THE DEVICE WAS NOT AVAILABLE FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED TO A REVIEW OF AVAILABLE INFORMATION, INCLUDING EVENT DETAILS AND RELEVANT RECORDS. NO DEFINITIVE FINDINGS WERE IDENTIFIED THAT COULD EXPLAIN THE REPORTED MALFUNCTION. AS A RESULT, A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE INFORMATION AVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED THAT A VALKYRIE DISPOSABLE POWER DRIVER (REF. NO. (B)(4), LOT NO. 250021-1345, EXPIRATION DATE: 02/23/2028) MALFUNCTIONED DURING USE IN A CORONARY ARTERY BYPASS GRAFT (CABG) PROCEDURE. THE DEVICE DID NOT FUNCTION AS INTENDED WHILE BEING USED BY THE SURGEON. THE DRIVER WAS REMOVED FROM THE SURGICAL FIELD, AND A REPLACEMENT DEVICE WAS OPENED AND USED TO CONTINUE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268259 VALKYRIE® - POWER DRIVER INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT KIJ JEIL MEDICAL CORPORATION 01-03-3035 250021-1345 08806390899796

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other