BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VELYS SAW INTERFACE RIGHT

    MDR report key: 13046685 · Received December 20, 2021

    Report

    Report Number
    1818910-2021-28233
    Event Type
    Malfunction
    Date Received
    December 20, 2021
    Date of Event
    November 11, 2021
    Report Date
    December 20, 2021
    Manufacturer
    DEPUY IRELAND UC
    Product Code
    OLO
    UDI-DI
    10603295519478
    PMA / PMN Number
    K202769
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. ADDITIONAL NARRATIVE: 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). DEVICE MANUFACTURE DATE IS UNKNOWN.

    Additional Manufacturer Narrative · 0

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. ADDITIONAL NARRATIVE: 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). DEVICE MANUFACTURE DATE IS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, IT WAS OBSERVED THAT EXCESSIVE MOVEMENT WAS EXPERIENCED WITH THE ROBOTIC-ASSISTED SAW SOLUTION SAW INTERFACE RIGHT DEVICE AND THE ARRAY WAS NOT VISIBLE. THE CASE WAS COMPLETED WITH NO ISSUES. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, IT WAS OBSERVED THAT EXCESSIVE MOVEMENT WAS EXPERIENCED WITH THE ROBOTIC-ASSISTED SAW SOLUTION SAW INTERFACE RIGHT DEVICE AND THE ARRAY WAS NOT VISIBLE. THE CASE WAS COMPLETED WITH NO ISSUES. 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
    1940134 VELYS SAW INTERFACE RIGHT ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO DEPUY IRELAND UC 4515-70-106 10603295519478

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown