BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEN CASEFRAME NON OPTICAL 230V

    MDR report key: 7776026 · Received August 13, 2018

    Report

    Report Number
    9680825-2018-00071
    Event Type
    Injury
    Date Received
    August 13, 2018
    Date of Event
    June 26, 2018
    Report Date
    August 9, 2018
    Manufacturer
    ORTHOFIX SRL
    Product Code
    JDX
    PMA / PMN Number
    K093805
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    ON JULY 2017 ORTHOFIX SRL ACQUIRED FROM ORTHOSONICS LTD, THE OSCAR SYSTEM, FOR ULTRASONIC ARTHROPLASTY REVISION. THEREFORE, ORTHOFIX SRL IS NOW MANAGING POST-MARKET SURVEILLANCE FOR OSCAR DEVICES, ALSO FOR THE ONES MANUFACTURED AND RELEASED TO THE MARKET BY ORTHOSONICS LTD. THE DEVICES INVOLVED IN THIS EVENT WERE MANUFACTURED BY ORTHOSONICS LTD. TECHNICAL EVALUATION: THE RETURNED DEVICES, RECEIVED ON JULY 6TH, 2018, WERE EXAMINED BY ORTHOFIX SRL QUALITY ENGINEERING DEPARTMENT. ALL DEVICES WERE SUBJECTED TO VISUAL AND FUNCTIONAL CHECK AS PER ORTHOFIX SRL SPECIFICATION. THE VISUAL CHECK DID NOT EVIDENCE ANY ANOMALIES. THE FUNCTIONAL CHECK EVIDENCED AS FOLLOWS: THE OSCAR 2 ULTRASONIC GENERATOR, (B)(4) IS FUNCTIONING PROPERLY. (MFR REPORT 9680825-2018-00071); THE CEMENT REMOVAL HANDSET FOR OSCAR 2, (B)(4) IS NOT FUNCTIONING PROPERLY. THE SEALING IS LOST FROM THE SWITCH BUTTON, THEREFORE THE HANDSET DOES NOT WORK. THE SIGNAL IS TRANSMITTING INTERMITTENTLY. (MFR REPORT 9680825-2018-00072); THE CEMENT REMOVAL HANDSET FOR OSCAR 2, (B)(4) IS NOT FUNCTIONING PROPERLY. THE CERAMICS INSIDE ARE BROKEN. THE HANDSET DOES NOT WORK DUE TO TOO LOW FREQUENCY EMITTED. (MFR REPORT 9680825-2018-00073). THE RESULTS OF THE TECHNICAL EVALUATION CONCLUDED AS FOLLOWS: THE OSCAR 2 ULTRASONIC GENERATOR, (B)(4) IS FUNCTIONING PROPERLY. THE FAILURE FOUND ON THE CEMENT REMOVAL HANDSET FOR OSCAR 2, (B)(4), IS MOST LIKELY ATTRIBUTABLE TO WATER THAT ENTERED INSIDE THE HANDSET DURING CLEANING AND STERILIZATION CYCLES. THIS MAY HAPPEN AS A RESULT OF NORMAL WEAR AND TEAR OF SILICONE SEALING OF THE SWITCH BUTTON. THE FAILURE FOUND ON THE CEMENT REMOVAL HANDSET FOR OSCAR 2, (B)(4) IS MOST LIKELY ATTRIBUTABLE TO A NORMAL WEAR AND TEAR OF THE INTERNAL CERAMICS. MEDICAL EVALUATION: THE INFORMATION MADE AVAILABLE ON THE CASE TOGETHER WITH THE RESULTS OF THE TECHNICAL INVESTIGATION WERE SENT TO OUR MEDICAL EVALUATOR. PLEASE FIND BELOW AN EXTRACT OF THE MEDICAL EVALUATION PERFORMED. ON (B)(6) 2018: "IN THIS CASE A PATIENT WAS HAVING A CEMENTED HIP REVISION. THE OSCAR SYSTEM WORKED WELL INITIALLY BUT THEN BECAME NON FUNCTIONAL. NO BACKUP SYSTEM WAS AVAILABLE. MANUAL TECHNIQUES OF CEMENT REMOVAL WERE USED AND THE OPERATION WAS COMPLETED AS PLANNED, BUT OVER A LONGER (UNSPECIFIED) TIME PERIOD. I AGREE WITH YOU THAT THIS SHOULD BE REPORTED AS YOU SUGGEST, BECAUSE OF THE LONGER TIME FRAME, BUT I THINK THAT THE EFFECT ON THE PATIENT WOULD HAVE BEEN MINIMAL". ON (B)(6) 2018 WITH THE RESULTS OF THE TECHNICAL EVALUATION: "I NOTE THAT IN THIS CASE THE OSCAR GENERATOR WAS AND IS FUNCTIONING NORMALLY, BUT THAT THE TWO CEMENT REMOVAL HANDSETS FAILED FOR DIFFERENT REASONS, BUT ATTRIBUTABLE TO NORMAL WEAR AND TEAR". FINAL COMMENTS: BASED ON THE RESULTS OF THE TECHNICAL EVALUATION, WHICH CONFIRMED THE ULTRASONIC GENERATOR CONFORMITY, AN ON THE EVIDENCES DERIVING FROM THE MEDICAL EVALUATION, ORTHOFIX SRL CAN CONCLUDE THAT THE PROBLEM THAT OCCURRED IS DUE TO NORMAL WEAR AND TEAR OF THE HANDSETS. ORTHOFIX SRL CONTINUES MONITORING THE DEVICES ON THE MARKET.

    Description of Event or Problem · 1

    THE INFORMATION INITIALLY PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: (B)(4). HOSPITAL NAME: (B)(6). SURGEON NAME: MR. (B)(6). DATE OF INITIAL SURGERY: (B)(6) 2018. BODY PART TO WHICH DEVICE WAS APPLIED: HIP. SURGERY DESCRIPTION: REVISION OF CEMENTED HIP. PATIENT INFORMATION: N.A. PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: INITIALLY OSCAR WORKED SATISFACTORILY, SOME PROXIMAL CEMENT WAS REMOVED FROM THE FEMUR USING THE BACK SCRAPER. THE NEEDLE THEN MOVED INTO THE RED, THE DEVICE STARTED HUMMING AND WOULD NOT TUNE. EVERYTHING WAS INTERCHANGED BUT TUNING COULD NOT BE OBTAINED. THE COMPLAINT REPORT FORM ALSO INDICATED: THE DEVICE FAILURE DID NOT HAVE ANY ADVERSE EFFECTS ON PATIENT; THE INITIAL SURGERY WAS NOT COMPLETED WITH THE DEVICE; A REPLACEMENT DEVICE WAS NOT IMMEDIATELY AVAILABLE TO COMPLETE SURGERY (SURGERY COMPLETED USING MANUAL TECHNIQUES); THE EVENT LED TO A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE SURGICAL PROCEDURE (MANUAL TECHNIQUES TAKING EXTRA TIME); AN ADDITIONAL SURGERY WAS NOT REQUIRED; A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED; COPIES OF THE OPERATIVE REPORT ARE NOT AVAILABLE; COPIES OF THE X-RAY IMAGES ARE NOT AVAILABLE; PATIENT CURRENT HEALTH CONDITIONS: NO RESPONSE. ADDITIONAL INFORMATION INCLUDED IN THE REVISED COMPLAINT FORM ORTHOFIX SRL RECEIVED ON AUGUST 7TH, 2018 PATIENT AGE: (B)(6); PATIENT SEX: F; PATIENT WEIGHT AND HEIGHT: NORMAL BMI. ADDENDUM TO SECTION "EVENT DESCRIPTION": WHEN THE HANDSET WAS ASSEMBLED AND THE WAVEGUIDES WERE INSERTED THE MACHINE STRUGGLED TO TUNE. A HIGH PITCHED SHRIEKING NOISE WAS PRESENT WHEN IT WAS OPERATING IN AIR BUT IN SPITE OF THIS IT WAS POSSIBLE TO REMOVE SOME OF THE CEMENT. EVENTUALLY OSCAR FAILED TO TUNE AT ALL AND IT WAS ABANDONED. I CARRIED OUT THE REMOVAL OF THE REMAINING CEMENT BY HAND AND USING RASPS. THIS ADDED APPROXIMATELY 5MINS TO THE TIME OF THE SURGERY. THE PATIENT UNDERWENT A SUCCESSFUL REVISION AND WAS IN GOOD HEALTH. NO ADVERSE EFFECTS WERE NOTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617330 GEN CASEFRAME NON OPTICAL 230V GEN CASEFRAME NON OPTICAL 230V JDX ORTHOFIX SRL OE3000B/2 2G420

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention