BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VELYS SATELLITE STATION

    MDR report key: 13954680 · Received March 30, 2022

    Report

    Report Number
    1818910-2022-04846
    Event Type
    Malfunction
    Date Received
    March 30, 2022
    Date of Event
    March 11, 2022
    Report Date
    March 17, 2022
    Manufacturer
    DEPUY IRELAND UC
    Product Code
    OLO
    UDI-DI
    10603295519492
    PMA / PMN Number
    K202769
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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. 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).

    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, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. 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. THE ACTUAL DEVICE WAS EVALUATED. DURING EVALUATION, IT WAS OBSERVED THAT THERE WERE NO ISSUES OR DEFECTS WITH THE SYSTEM OR SOFTWARE IDENTIFIED. IT WAS DETERMINED THAT THE SYSTEM AND SOFTWARE PERFORMED AS INTENDED. AN ANALYSIS OF THE LOG FILES WAS PERFORMED AND IT WAS IDENTIFIED THAT THERE WAS A SUB-OPTIMAL ACQUISITION PERFORMED. IT WAS DETERMINED THAT THERE APPEARED TO BE AN EXTERNAL ROTATION OF THE TIBIA'S AP DIRECTION. IT WAS NOTED THAT THE SURGEON HAD LIMITED EXPERIENCE USING THE SYSTEM, USING THE SYSTEM FOR ONLY 1-2 SURGICAL PROCEDURES. THE SURGEON WAS MADE AWARE TO ENSURE THE AP DIRECTION IS TAKEN CORRECTLY. IT WAS NOTED THAT SUBSEQUENT CASES HAVE BEEN COMPLETED SUCCESSFULLY WITHOUT ISSUE. THEREFORE, THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO SUB-OPTIMAL ACQUISITION DUE TO USE ERROR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOLLOWING A TOTAL KNEE PROCEDURE, WHILE USING THE ROBOT ASSISTED BASE STATION DEVICE AND THE SATELLITE STATION DEVICE, THE CLINICIAN REVIEWED THE X-RAYS AND FELT THAT THE CUT WAS "WAY MORE THAN THE TWO DEGREES" ADDED TO THE TIBIA CUT. IT WAS REPORTED THAT THERE WERE NO ISSUES WITH THE SYSTEM DURING THE SURGICAL PROCEDURE AND THE ENTIRE SURGERY WENT "SMOOTH"/"NEAR PERFECT". THE REPORTER STATED THE CUTS WERE NOT CHECKED DURING THE SURGICAL PROCEDURE. IT WAS NOT REPORTED THAT THERE WERE NO DELAYS IN THE SURGICAL PROCEDURE. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. IT WAS REPORTED THAT THE PATIENT'S POST-SURGICAL OUTCOME WOULD NOT BE KNOWN FOR SEVERAL WEEKS. 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
    1345030 VELYS SATELLITE STATION ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO DEPUY IRELAND UC 4515-70-101 10603295519492

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown