BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VELYS SATELLITE STATION

    MDR report key: 13738058 · Received March 11, 2022

    Report

    Report Number
    1818910-2022-04387
    Event Type
    Malfunction
    Date Received
    March 11, 2022
    Date of Event
    February 25, 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. UDI: (B)(4). CONCOMITANT MEDICAL DEVICES AND THERAPY DATES, BASE STATION DEVICE AND, (B)(6), 2022.

    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. INVESTIGATION SUMMARY: THE ACTUAL DEVICE WAS EVALUATED. THE INVESTIGATION OF THE LOG FILES FOUND THAT THE REPORTED RESECTIONS WERE MOST LIKELY DIFFERENT FROM PLANNING DUE TO THE IDENTIFIED ARRAY MOVEMENT NOT BEING CORRECTED DURING THE PROCEDURE. THE INVESTIGATION FOUND THE SURGEON DID NOT CORRECT FOR THIS ARRAY MOVEMENT WHICH WOULD ACCOUNT FOR THE DISCREPANCY FOUND IN THE FEMUR CUT, ANTERIOR CUT, AND THE POSTERIOR CHAMFER, AND LOOSE TRIAL IN FLEXION. DURING INVESTIGATION, THERE WERE NO DEFECTS WITH THE SYSTEM OR SOFTWARE OBSERVED. THE SYSTEM AND SOFTWARE PERFORMED AS DESIGNED. THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO NOT CORRECTING FOR THE FEMUR ARRAY MOVEMENT WHICH LEAD TO THE DISCREPANCY IN THE FEMORAL CUTS AND LOOSE TRIAL IN FLEXION, WHICH IS USER ERROR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A TIBIA FIRST TOTAL KNEE SURGERY, IT WAS OBSERVED THAT THE DISTAL RESECTION ON THE FEMUR CUT WAS OFF 2-3MM WHILE USING THE SATELLITE STATION DEVICE AND BASE STATION DEVICES. ADDITIONALLY, IT WAS REPORTED THAT THE ANTERIOR CUT WAS OVER RESECTED BY 1-2MM. IT WAS FURTHER REPORTED THAT THE POSTERIOR CHAMFER WAS OVER RESECTED AND THE CUT WAS NOT FLAT. IT WAS REPORTED THAT THE TRIALS WERE LOOSE IN FLEXION AND THE USER CHANGED TO MANUAL INSTRUMENTATION. IT WAS REPORTED THAT THERE WAS AN UNSPECIFIED DELAY IN ORDER TO CHANGE 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
    1867551 VELYS SATELLITE STATION ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO DEPUY IRELAND UC 4515-70-101 10603295519492

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown