BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSCAR PRO GENERATOR

    MDR report key: 18594130 · Received January 29, 2024

    Report

    Report Number
    9680825-2024-00003
    Event Type
    Injury
    Date Received
    January 29, 2024
    Date of Event
    January 19, 2024
    Report Date
    March 21, 2024
    Manufacturer
    ORTHOFIX SRL
    Product Code
    JDX
    PMA / PMN Number
    EXEMPT/JDX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    TECHNICAL EVALUATION: THE RETURNED OSCAR GENERATOR, RECEIVED ON 1 FEBRUARY 2024, WAS EXAMINED BY ORTHOFIX QUALITY OPERATIONS DEPARTMENT. THE VISUAL CHECK EVIDENCED SIGNS OF DAMAGE ON THE GENERATOR CASE. THE FUNCTIONAL CHECK EVIDENCED THAT THE HMI BOARD ASSY IN THE GENERATOR IS MALFUNCTIONING DUE TO A DAMAGE TO THE AUDIO OUTPUT. CONCLUSIONS: THE TECHNICAL ANALYSIS PERFORMED DID NOT EVIDENCE THE PROBLEM NOTIFIED BY THE CUSTOMER: "THE OSCAR PRO SYSTEM DOESN'T WORK. POWER IS NOT REACHING THE SENSOR. NO EFFECT ON CEMENT. GENERATOR DETECTS NO ERROR". THE ANALYSIS OF THE ELECTRICAL COMPONENTS EVIDENCED A MALFUNCTION OF THE HMI BOARD ASSY RELATED TO THE DAMAGE OF THE AUDIO OUTPUT (PN 4ET00404 - TPA2005D1DGN AUDIO AMPLIFIER). THIS COULD BE RELATED TO EARLY FAILURE OF THE ELECTRICAL COMPONENT OF THE GENERATOR, WHICH ORIGIN COULD NOT BE IDENTIFIED. ORTHOFIX CAN CONFIRM THAT THE GENERATOR S/N (B)(6) WAS SERVICED IN YEAR 2022 AND NO ANOMALIES WERE DETECTED ON COMPONENT PN 4ET00404-AUDIO OUTPUT. ORTHOFIX SRL CONTINUES MONITORING THE DEVICES ON THE MARKET.

    Additional Manufacturer Narrative · 0

    TECHNICAL EVALUATION THE DEVICE INVOLVED IN THIS EVENT HAS NOT YET BEEN RECEIVED BY ORTHOFIX SRL. ORTHOFIX SRL IS STRICTLY IN CONTACT WITH THE LOCAL DISTRIBUTOR TO HAVE THE DEVICE CONCERNED. THE TECHNICAL EVALUATION WILL BE PERFORMED AS SOON AS THE DEVICE BECOMES AVAILABLE. AS SOON AS THE RESULTS OF THE INVESTIGATION ARE AVAILABLE, ORTHOFIX SRL WILL PROVIDE A FOLLOW UP REPORT. ORTHOFIX SRL CONTINUES MONITORING THE DEVICES ON THE MARKET.

    Description of Event or Problem · 0

    THE INFORMATION PROVIDED BY LOCAL DISTRIBUTOR INDICATES: - HOSPITAL NAME: (B)(6). - SURGEON'S NAME: DR. (B)(6). - DATE OF INITIAL SURGERY: (B)(6) 2024. - BODY PART TO WHICH DEVICE WAS APPLIED: FEMUR. - SURGERY DESCRIPTION: ARTHROPLASTY REVISION. - PATIENT INFORMATION: 76-YEAR-OLD, FEMALE. - PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE. - TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. - EVENT DESCRIPTION: THE OSCAR PRO SYSTEM DOESN'T WORK. POWER IS NOT REACHING THE SENSOR. NO EFFECT ON CEMENT. GENERATOR DETECTS NO ERROR. THE COMPLAINT REPORT FORM ALSO INDICATES: - THE DEVICE FAILURE DID NOT HAVE ANY ADVERSE EFFECTS ON PATIENT. - IT WAS POSSIBLE TO FINISH THE INTERVENTION, THE SYSTEM WORKED AFTER THE GENERATOR WAS MANIPULATED BETWEEN MENUS AFTER 3 HOURS, EXPOSING THE PATIENT TO FRACTURES AND RISKS. - THE EVENT LED TO A DELAY IN THE DURATION OF THE SURGICAL PROCEDURE: 3 HOURS. - AN ADDITIONAL SURGERY WAS NOT REQUIRED FOLLOWING DEVICE FAILURE. - COPY OF X-RAY IMAGES IS AVAILABLE. - PATIENT'S CURRENT HEALTH CONDITION: UNKNOWN. MANUFACTURER REFERENCE NUMBER: (B)(4). DISTRIBUTOR REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    THE INFORMATION PROVIDED BY LOCAL DISTRIBUTOR INDICATES: - HOSPITAL NAME: (B)(6)- SURGEON'S NAME: (B)(6) - DATE OF INITIAL SURGERY: (B)(6) 2024 - BODY PART TO WHICH DEVICE WAS APPLIED: FEMUR - SURGERY DESCRIPTION: ARTHROPLASTY REVISION - PATIENT INFORMATION: 76-YEAR-OLD, FEMALE - PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE - TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM - EVENT DESCRIPTION: THE OSCAR PRO SYSTEM DOESN'T WORK. POWER IS NOT REACHING THE SENSOR. NO EFFECT ON CEMENT. GENERATOR DETECTS NO ERROR. THE COMPLAINT REPORT FORM ALSO INDICATES: - THE DEVICE FAILURE DID NOT HAVE ANY ADVERSE EFFECTS ON PATIENT - IT WAS POSSIBLE TO FINISH THE INTERVENTION, THE SYSTEM WORKED AFTER THE GENERATOR WAS MANIPULATED BETWEEN MENUS AFTER 3 HOURS, EXPOSING THE PATIENT TO FRACTURES AND RISKS. - THE EVENT LED TO A DELAY IN THE DURATION OF THE SURGICAL PROCEDURE: 3 HOURS - AN ADDITIONAL SURGERY WAS NOT REQUIRED FOLLOWING DEVICE FAILURE - COPY OF X-RAY IMAGES IS AVAILABLE - PATIENT'S CURRENT HEALTH CONDITION: UNKNOWN MANUFACTURER REFERENCE NUMBER:(B)(4) DISTRIBUTOR REFERENCE NUMBER: 11.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    797738 OSCAR PRO GENERATOR OSCAR PRO GENERATOR JDX ORTHOFIX SRL

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Required Intervention