BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VELYS ARRAY SET KNEE

    MDR report key: 23692025 · Received December 2, 2025

    Report

    Report Number
    1818910-2025-20841
    Event Type
    Malfunction
    Date Received
    December 2, 2025
    Date of Event
    October 14, 2025
    Manufacturer
    DEPUY IRELAND
    Product Code
    OLO
    UDI-DI
    10603295520146
    PMA / PMN Number
    K202769
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT#: (B)(4). INVESTIGATION SUMMARY: ACCORDING TO THE INFORMATION RECEIVED, ¿REP STATED WHILE HALFWAY THROUGH THE LAST CUT THE ROBOT DROPPED, CHANGING THE CUT ANGLE COMPLETELY". THE VELYS ARRAY SET KNEE WAS NOT RETURNED TO MEDTECH ORTHOPAEDICS. HOWEVER, LOG FILE REVIEW WAS PERFORMED BY THE SYSTEMS TEAM ON THE INVOLVED VELYS BASE STATION ((B)(4)). THE INVESTIGATION FOUND THAT LEG WAS SUB-OPTIMALLY POSITIONED IN LOG FILES ANALYZED. ADDITIONALLY, THE MESSAGE: POPUP {INSTRUCTION: "SYSTEM HAS DETECTED EXCESSIVE LEG MOVEMENT" {DETAILED INSTRUCTION: "STABILIZE THE KNEE"} IS DISPLAYED AT LEAST ONCE DURING ONE OF THE CUT STEPS. AS THE ROBOT IS NOT MOUNTED TO THE BEDRAIL, IT IS LIKELY THAT COMBINATION OF LEG/ROBOT MOVEMENT AND LEG POSITIONING WAS LEADING TO THIS REPEATED MESSAGE. THE INVESTIGATION ALSO FOUND THAT BOTH FEMUR AND TIBIAL CHECKPOINTS WERE CREATED ON THE RESPECTIVE ARRAYS ITSELF AND NOT ON THE BONES IN ALL THE LOG FILES ANALYZED, SO POTENTIAL ARRAY MOVEMENT CANNOT BE CONFIRMED, BUT CANNOT BE RULED OUT, . SINCE THE CHECKPOINTS WERE PLACED ON THE ARRAYS, THEY LOSE THEIR PURPOSE. WHEN THE ARRAY MOVES THE CHECKPOINT MOVES WITH IT, SO THE USER WOULD HAVE NO WAY OF DETERMINING THE ARRAY HAD MOVED LOCATIONS. ADDITIONALLY, THERE WERE MULTIPLE MESSAGES OF "SAW TRACKER VISIBILITY LOST " AND "TARGET (BONE" TRACKER VISIBILITY LOST" DISPLAYED IN 3 OF THE CASE LOGS ANALYZED, PARTICULARLY DURING THE LAST CUT STEP OF THE RESPECTIVE PROCEDURES. MULTIPLE MESSAGES OF "BLOCKEDTRACKER" ALSO DISPLAYED DURING MOST OF THE CUT STEPS. THIS INDICATES THAT BOTH SAW ARRAY AND BONE ARRAY ARE NOT CONSISTENTLY VISIBLE TO THE CAMERA AND EVENTUALLY THE SYSTEM CANNOT DETECT ARRAY POSITION ACCURATELY. THIS WOULD CAUSE THE SYSTEM TO CUT THE POWER TO THE SAW HANDPIECE UNTIL THE VISIBILITY IS RESTORED. THIS WOULD HAVE BEEN CAUSED BY THE USER BY NOT POSITIONING THE CAMERA, SAW HANDPIECE, AND THE TARGET BONE ARRAY DURING THE CUTS IN SUCH A WAY THAT THE CAMERA'S LINE OF SIGHT TO EACH ARRAY IS CLEAR. THE ARRAYS ARE FREQUENTLY BLOCKED THROUGHOUT THE CUT STEPS. IT IS THE INTENDED BEHAVIOR OF THE SYSTEM TO CUT POWER TO THE SAW IF THE BONE ARRAY BECOMES BLOCKED. RECOMMENDATIONS: IT IS RECOMMENDED THAT THE USER FOLLOW THE GUIDANCE ON INTRAOPERATIVE USE ON PAGE 157 OF THE IFU 090260022SW19 REV A PRIOR TO EACH RESECTION, ENSURE THE LEG IS STABILIZED IN THE DESIRED POSITION. ANY LARGE LEG MOVEMENT WILL REQUIRE A RAPID ADJUSTMENT BY THE ROBOTIC-ASSISTED DEVICE AND CAN POTENTIALLY INTRODUCE INACCURACY IT IS RECOMMENDED THAT THE USER FOLLOW THE GUIDANCE ON IFU-090260022SW19 REV A PAGES 121 AND 127 INTRAOPERATIVE USE: BONE CHECKPOINTS CREATION. POSITION EACH CHECKPOINT AT A SITE WHERE THE BONE WILL NOT BE RESECTED, E.G., BELOW THE ANTICIPATED TIBIAL RESECTION PLANE. CREATE EACH CHECKPOINT CAUTIOUSLY WITH THE APPROPRIATE INSTRUMENT AND INTO THE CORTICAL BONE. THE CHECKPOINTS MUST BE EASILY IDENTIFIABLE LATER DURING THE PROCEDURE. MARKING THE CHECKPOINTS WITH A SURGICAL PEN WILL FACILITATE FINDING THEIR LOCATION. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT: A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED AS NO LOT NUMBER WAS PROVIDED FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. H11: ADDITIONAL NARRATIVE: D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED HALFWAY THROUGH THE LAST CUT, THE ROBOT DROPPED; THIS CHANGED THE CUT ANGLE. THE ROBOT WAS CART MOUNTED. THE CUT WAS ROUGHLY FOUR MILLIMETERS (4MM) OFF; THE PROCEDURE WAS COMPLETED MANUALLY MINIMIZING TO TWO TO THREE MILLIMETERS (2-3MM) WITH CEMENT. THE PROCEDURE WAS DELAYED FOR ABOUT FIFTEEN (15) MINUTES; IT WAS NOTED THAT THE ARRAY MOVING CAUSED THE ROBOT ARM TO CHANGE ANGLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218511 VELYS ARRAY SET KNEE ROBOTIC-ASSISTED SOLUTION - DEVICE ARRAY OLO DEPUY IRELAND 10603295520146

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown