BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VELYS SAW HANDPIECE

    MDR report key: 13953873 · Received March 30, 2022

    Report

    Report Number
    1818910-2022-05832
    Event Type
    Malfunction
    Date Received
    March 30, 2022
    Date of Event
    March 2, 2022
    Report Date
    March 30, 2022
    Manufacturer
    DEPUY IRELAND UC
    Product Code
    OLO
    UDI-DI
    10603295519430
    PMA / PMN Number
    K202769
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED. THE DEVICE SERIAL OR LOT NUMBER WAS UNKNOWN; THEREFORE, UDI: (B)(4). UNKNOWN. DEVICE MANUFACTURE DATE IS UNKNOWN. THE DEVICE SERIAL OR LOT NUMBER IS UNKNOWN. CONCOMITANT MEDICAL DEVICES AND THERAPY DATES, ROBOTIC ASSISTED SATELLITE STATION AND ARRAY SET, (B)(6) 2022. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROSCOPY PROCEDURE AND WHILE IN THE MIDDLE OF MAKING THE FEMUR CUTS, THE ARRAY DEVICE "POPPED" OFF OF THE ROBOTIC ASSISTED SAW HANDPIECE NEAR THE BLADE. IT WAS REPORTED THAT THE DEVICE WAS ALSO BEING USED WITH A ROBOTIC ASSISTED SATELLITE STATION. IT WAS FURTHER REPORTED THAT IT WAS VERIFIED THE ARRAY ATTACHED INTO THE SAW PROPERLY BY HEARING AND FEELING IT CLICK INTO PLACE. IT WAS REPORTED THAT THERE WERE NO DELAYS IN THE SURGICAL PROCEDURE. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1420759 VELYS SAW HANDPIECE INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT OLO DEPUY IRELAND UC 4515-70-102 10603295519430

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown