BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VELYS SAW BLADE

    MDR report key: 23585660 · Received November 18, 2025

    Report

    Report Number
    1818910-2025-20272
    Event Type
    Injury
    Date Received
    November 18, 2025
    Date of Event
    September 12, 2025
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    OLO
    UDI-DI
    10603295519140
    PMA / PMN Number
    K202769
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #: (B)(4). INVESTIGATION SUMMARY: ACCORDING TO THE INFORMATION RECEIVED, ¿THE SURGEON EXPLAINED THAT HE DID NOT USE RETRACTORS AS USUAL FOR A RECUT AND FACED A POPLITEAL ARTERIA INJURY. HE MADE A SUTURE DIRECTLY ON THE ARTERIA AND THE PATIENT HAD NO MAJOR HEMORAGIA, AND NO OTHER VASCULAR SURGERY NEEDED¿. THE VELYS SAW BLADE WAS NOT RETURNED TO DEPUY SYNTHES. HOWEVER, WITH THE AVAILABLE INFORMATION IT IS KNOW THAT THE SURGEON DID NOT USE THE RETRACTORS DURING THE RESECTION PROCESS. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU-0902-60-022 REV. M), UNDER THE SECTION PERFORMING RESECTION, IT STATES: ¿PLACE RETRACTORS TO PROTECT SOFT TISSUES DURING THE BONE RESECTIONS. THE RETRACTORS MUST BE PLACED SO THEY CAN BE HELD BY THE ASSISTANT WITHOUT BLOCKING THE LINE OF SIGHT BETWEEN THE ARRAYS AND THE CAMERA.¿ ADDITIONALLY, UNDER THE SECTION INTRAOPERATIVE USE, THE FOLLOWING CAUTIONS ARE MENTIONED: ¿THERE ARE NO MECHANICAL BOUNDARIES ON THE SAW BLADE. THEREFORE, IT MUST BE CONTROLLED AT ALL TIMES BY THE SURGEON. PRIOR TO EACH RESECTION, ENSURE THE LEG IS STABILIZED IN THE DESIRED POSITION, AND RETRACTORS ARE SUITABLY PLACED.¿ AND ¿INCOMPLETE RETRACTOR PLACEMENT EXPOSES SOFT TISSUES TO POTENTIAL DAMAGE.¿ 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

    THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). 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. 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

    POPLITEAL ARTERIA INJURY WHILE USING VELYS DURING A KNEE ARTHROPLASTY. THE SURGEON EXPLAINED THAT THEY DID NOT USE RETRACTORS AS USUAL FOR A RECUT AND FACED A POPLITEAL ARTERIA INJURY. THEY MADE A SUTURE DIRECTLY ON THE ARTERIA TO STOP THE BLEEDING AND THE PATIENT HAD NO MAJOR HEMORAGIA, AND NO OTHER VASCULAR SURGERY NEEDED. ARTHERIOGRAPHY WAS DONE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A FIFTEEN MINUTE DELAY. PATIENT RECEIVED SURVEILLANCE IN THE ICU FOR A NIGHT AND A PLATELET-INHIBITING AGENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2234694 VELYS SAW BLADE INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT OLO DEPUY IRELAND - 9616671 10603295519140

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention