BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOLT¿ WRIST TREATMENT SYSTEM

    MDR report key: 22857395 · Received August 20, 2025

    Report

    Report Number
    3012966183-2025-00020
    Event Type
    Malfunction
    Date Received
    August 20, 2025
    Date of Event
    July 14, 2025
    Report Date
    August 20, 2025
    Manufacturer
    TYBER MEDICAL
    Product Code
    HRS
    PMA / PMN Number
    K232693
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT WAS EVALUATED AND INVESTIGATED AIDED BY PROVIDED IMAGES THAT CONFIRMED THE EVENT. THE AFFECTED DEVICE WAS NOT AVAILABLE FOR RETURN; THEREFORE A DEVICE EVALUATION WAS UNABLE TO BE PERFORMED. A DEVICE HISTORY RECORD REVIEW COULD NOT BE COMPLETED FOR LOT RELATED NONCONFORMITIES COULD NOT BE PERFORMED AS NO LOT NUMBER WAS RETURNED. ADDITIONAL INFORMATION WAS RECEIVED BY THE INITIAL COMPLAINANT AND A THIRD-PARTY THAT CONFIRMED SURGICAL INSTRUMENTATION RECOMMENDED IN THE SURGICAL TECHNIQUE GUIDE WAS NOT USED AND COULD HAVE CONTRIBUTED TO THE EVENT. A HISTORICAL DATA ANALYSIS IDENTIFIED ZERO TRENDS OR CAPAS RELATED TO THE NATURE OF THIS COMPLAINT. THE ROOT CAUSE CANNOT BE DEFINITIVELY ESTABLISHED WITH THE CURRENT INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED TO THE SALES CONSULTANT THAT THE A 2.4MM VOLT DISTAL LOCKING SCREW BACKED OUT OF ITS SCREW HOLE ON THE VOLT DISTAL RADIUS PLATE (02.426.541) POST OPERATIVELY. SEE ATTACHED PICTURE. STAFF BELIEVE THE SURGEON USED THE 2.4 LOCKING SIDE (03.424.186) FOR THEIR DRILL GUIDE TO ESTABLISH THE SCREW TRAJECTORY. STAFF ARE NOT SURE OF HOW MUCH TORQUE THE SURGEON PUT ON THE SCREW. ADDITIONAL INFORMATION RECEIVED 22JUL2025: THE FOLLOWING POTENTIALLY RELEVANT DETAILS CAME TO LIGHT ABOUT THE CASE: - A TORQUE LIMITING ATTACHMENT WAS NOT USED WHICH MAY RESULT IN INSUFFICIENT TORQUE APPLIED TO GUARANTEE PROPER LOCKING. -THE SCREW WAS INITIALLY INSERTED, THEN REMOVED, A DIFFERENT TRAJECTORY DRILLED AND SCREW RE-INSERTED. -THE VARIABLE-ANGLE SIDE OF THE DOUBLE-ENDED DRILL GUIDE WAS USED. DEPENDING ON A NUMBER OF FACTORS, IT IS POSSIBLE THAT THE ANGULATION LIMITS WERE NOT DETECTED BY THE USER. - ORIGINAL IMPLANT DATE WAS (B)(6) 2025 AND THE DEVICE WAS EXPLANTED (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1974382 VOLT¿ WRIST TREATMENT SYSTEM 2.4/2.7 2COLUMN DIST RADIUS PLATE 6HEAD/4SHAFT/LEFT/NRW/69MM HRS TYBER MEDICAL 02.426.541

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other