BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VELYS ROBOTIC-ASSISTED SOLUTION SAW HANDPIECE

    MDR report key: 24998401 · Received April 27, 2026

    Report

    Report Number
    MW5187262
    Event Type
    Injury
    Date Received
    April 27, 2026
    Date of Event
    April 20, 2026
    Report Date
    April 20, 2026
    Manufacturer
    DEPUY SYNTHES / DEPUY IRELAND UC
    Product Code
    OLO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING LEFT TKA ROBOTICALLY ASSISTED VELYS CASE- VELYS SAW HAND PIECE BROKE. NO HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1071628 VELYS ROBOTIC-ASSISTED SOLUTION SAW HANDPIECE ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO DEPUY SYNTHES / DEPUY IRELAND UC 4515-70-102

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Required Intervention