BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VELYS SATELLITE STATION

    MDR report key: 13737883 · Received March 11, 2022

    Report

    Report Number
    1818910-2022-04555
    Event Type
    Malfunction
    Date Received
    March 11, 2022
    Date of Event
    February 23, 2022
    Report Date
    March 10, 2022
    Manufacturer
    DEPUY IRELAND UC
    Product Code
    OLO
    UDI-DI
    10603295519492
    PMA / PMN Number
    K202769
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. 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. CONCOMITANT MEDICAL DEVICES AND THERAPY DATES, ARRAY SET DEVICE AND BASE STATION DEVICE, (B)(6), 2022. UDI: (B)(4).

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. 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. H10 ADDITIONAL NARRATIVE: INVESTIGATION SUMMARY THE ACTUAL DEVICE WAS EVALUATED. THE INVESTIGATION SHOWED THAT THERE WAS FEMUR BONE ARRAY MOVEMENT DUE TO MOVEMENT OF THE HIP CENTER BETWEEN 10 - 15 MM. IT WAS ALSO SHOWN THE SURGEON DID NOT CORRECT FOR THIS ARRAY MOVEMENT, WHICH COULD ACCOUNT FOR THE IMPLANT SIZING ISSUES DURING THE PROCEDURE. DURING INVESTIGATION, THERE WERE NO DEFECTS WITH THE SYSTEM OR SOFTWARE OBSERVED. THE SYSTEM AND SOFTWARE PERFORMED AS DESIGNED. THE USER INDICATED THAT THERE WAS NO NEGATIVE IMPACT TO THE PATIENT OUTCOME AND NO PATIENT HARM AND THE INVESTIGATION INDICATES THAT THE SYSTEM WAS BEHAVING PROPERLY. THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO NOT CORRECTING FOR THE OBSERVED FEMUR BONE ARRAY MOVEMENT WHICH LEAD TO THE DISCREPANCY IN THE DISTAL CUT AND THE IMPLANT SIZING ISSUES, WHICH IS USER ERROR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A TOTAL KNEE SURGERY, TIBIA FIRST, WHILE USING A ROBOTIC ASSISTED BASE STATION DEVICE, SATELLITE STATION DEVICE AND AN ARRAY SET DEVICE, THE DISTAL FEMUR CUT WAS OFF DUE TO POSSIBLE ARRAY MOVEMENT OR BAD BONE QUALITY. IT WAS REPORTED THAT THE DEVICE RECOMMENDED A SIZE 8 TRIAL BUT IT WAS TOO TIGHT. IT WAS FURTHER REPORTED THAT THE USER USED A SIZE 7 AND OBSERVED THAT IT WAS ALSO TOO TIGHT. IT WAS REPORTED THAT THE PROCEDURE WAS CHANGED TO A MANUAL INSTRUMENTATION AND A SIZE 6 TRIAL WAS THE CORRECT FIT. IT WAS REPORTED THAT THERE WAS AN UNSPECIFIED DELAY DUE TO SWITCHING TO MANUAL INSTRUMENTATION. IT WAS REPORTED THAT THERE WAS NO PATIENT HARM AND THE SURGERY WAS COMPLETED SUCCESSFULLY. 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
    1150973 VELYS SATELLITE STATION ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO DEPUY IRELAND UC 4515-70-101 10603295519492

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown