BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE USE 8MM PIERCER PROBE - STERILE

    MDR report key: 8013261 · Received October 29, 2018

    Report

    Report Number
    9680825-2018-00093
    Event Type
    Injury
    Date Received
    October 29, 2018
    Date of Event
    September 25, 2018
    Report Date
    January 8, 2019
    Manufacturer
    ORTHOFIX SRL
    Product Code
    JDX
    PMA / PMN Number
    K093805
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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. DEVICES INVOLVED IN THIS EVENT WERE MANUFACTURED BY ORTHOSONICS LTD. TECHNICAL EVALUATION: A TECHNICAL EVALUATION OF THE DEVICES INVOLVED WAS NOT POSSIBLE AS THEY WERE NOT RETURNED TO ORTHOFIX SRL. MEDICAL EVALUATION: THE INFORMATION MADE AVAILABLE ON THE CASE WAS SENT TO OUR MEDICAL EVALUATOR . PLEASE SEE BELOW AN EXTRACT OF THE MEDICAL EVALUATION PERFORMED: IN THIS CASE A HIP REVISION WAS BEING CARRIED OUT AND THE OSCAR EQUIPMENT SEEMED ONLY TO WORK INTERMITTENTLY WITH LONG DELAYS. AS A RESULT THE OPERATION WAS DELAYED FOR 2 - 3 HOURS, AND BECAUSE OF THIS IS DEFINED AS A SERIOUS INJURY AND IS REPORTABLE. AS FAR AS WE KNOW THE OPERATION WAS COMPLETED AS PLANNED AND THE PATIENT IS FINE. I CANNOT COMMENT ON THE DETAILS BECAUSE WE HAVE NO MORE INFORMATION. HOWEVER, I DO SAY THAT I AM NOT SURE HOW HOSPITALS EXPECT TO CARRY OUT THESE OPERATIONS WITHOUT A BACKUP SYSTEM. THIS IS A SERIOUS INJURY PRIMARILY BECAUSE OF THE DELAY. FINAL COMMENTS: A TECHNICAL EVALUATION OF THE DEVICES INVOLVED WAS NOT POSSIBLE AS THEY WERE NOT RETURNED TO ORTHOFIX SRL. BASED ON THE INFORMATION AVAILABLE ON THE EVENT, IT WAS NOT POSSIBLE TO FINALIZE THE INVESTIGATION AND DETERMINE THE ROOT CAUSE OF THE EVENT NOTIFIED. ORTHOFIX SRL HISTORICAL RECORDS SHOW THAT NO OTHER SIMILAR NOTIFICATIONS HAVE BEEN RECEIVED IN REGARDS TO THESE SPECIFIC DEVICE LOTS. IN CASE FURTHER INFORMATION IS RECEIVED OR THE DEVICES INVOLVED ARE RETURNED, ORTHOFIX SRL WILL PROMPTLY RE-OPEN THE ISSUE AND FINALIZE THE INVESTIGATION. ORTHOFIX SRL CONTINUES MONITORING THE DEVICES ON THE MARKET. PLEASE KINDLY REFER ALSO TO MFR REPORT NUMBER 9680825-2018-00092 FOLLOW UP 1; (B)(4).

    Description of Event or Problem · 0

    THE INFORMATION INITIALLY PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6). SURGEON NAME: DR. (B)(6). DATE OF INITIAL SURGERY: (B)(6) 2018. BODY PART TO WHICH DEVICE WAS APPLIED: HIP. SURGERY DESCRIPTION: UNAVAILABLE. PATIENT INFORMATION: M.E.M, MALE. PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: PER THE TM, DURING A CASE ON 9/25/18 AT UNIV. OF CONNECTICUT HSP WITH DR. HALAWI, THE PROBE OHP2080SU (LOT NUMBER WO/19982/A) WOULD NOT TUNE TO FREQUENCY. THEY NEEDED TO HAVE THE ULTRAONSIC WAVE TO BE TRANSFERRED THROUGH PROBE AND WOULD NOT WORK. THE GENERATOR, (LOT 384) THAT THEY WERE USING WOULD NOT WORK. THE CASE WAS DELAYED BY 2 TO THREE HOURS, 2 OF THE 3 MODULES WOULD NOT WORK. THE DOCTOR WOULD TRY TO REMOVE CEMENT. SOMETIMES IT WOULD WORK FOR 10-11 SECONDS OR 10 MINUTES THEN WOULD STOP. THEY WOULD HAVE TO IT TURN OFF AND ON THE GENERATOR AND EVENTUALLY WOULD WORK BUT ONLY INTERMITTENTLY. TOWARDS THE END OF THE SURGERY, IT DID START TO WORK. THE COMPLAINT REPORT FORM ALSO INDICATED: THE DEVICE FAILURE DID NOT HAVE ANY ADVERSE EFFECTS ON PATIENT. THE INITIAL SURGERY WAS COMPLETED WITH THE DEVICE. THE EVENT LED TO A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE SURGICAL PROCEDURE: 2 TO 3 HOURS DELAY. 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: UNKNOWN. MANUFACTURER REFERENCE NUMBER: (B)(4). DISTRIBUTOR REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    ON JULY 2017 ORTHOFIX (B)(4) ACQUIRED FROM ORTHOSONICS LTD, THE OSCAR SYSTEM, FOR ULTRASONIC ARTHROPLASTY REVISION. THEREFORE, ORTHOFIX (B)(4) 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 DEVICES INVOLVED IN THIS EVENT HAVE NOT BEEN RETURNED TO ORTHOFIX (B)(4). AS SOON AS THE DEVICES ARE RECEIVED, ORTHOFIX (B)(4) WILL PERFORM THE TECHNICAL ANALYSIS. MEDICAL EVALUATION: THE INFORMATION MADE AVAILABLE ON THE CASE WAS SENT TO OUR MEDICAL EVALUATOR. A PRELIMINARY MEDICAL EVALUATION WAS PERFORMED AND WILL BE FINALIZED ONCE THE RESULTS OF THE TECHNICAL EVALUATION AND/OR FURTHER INFORMATION ARE AVAILABLE. AS SOON AS THE RESULTS OF THE INVESTIGATION ARE AVAILABLE, ORTHOFIX (B)(4) WILL PROVIDE YOU WITH A FOLLOW UP REPORT. ORTHOFIX (B)(4) CONTINUES MONITORING THE DEVICES ON THE MARKET. PLEASE KINDLY REFER ALSO TO MFR REPORT NUMBER 9680825-2018-00092. (B)(4).

    Description of Event or Problem · 1

    THE INFORMATION INITIALLY PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6). SURGEON NAME: DR. (B)(6). DATE OF INITIAL SURGERY: (B)(6) 2018. BODY PART TO WHICH DEVICE WAS APPLIED: HIP. SURGERY DESCRIPTION: UNAVAILABLE. PATIENT INFORMATION: (B)(6), MALE. PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: PER THE TM, DURING A CASE ON (B)(6) 2018 AT (B)(6) HSP WITH DR.(B)(6), THE PROBE OHP2080SU (LOT NUMBER WO/19982/A) WOULD NOT TUNE TO FREQUENCY. THEY NEEDED TO HAVE THE ULTRASONIC WAVE TO BE TRANSFERRED THROUGH PROBE AND WOULD NOT WORK. THE GENERATOR, (LOT 384) THAT THEY WERE USING WOULD NOT WORK. THE CASE WAS DELAYED BY 2 TO THREE HOURS, 2 OF THE 3 MODULES WOULD NOT WORK. THE DOCTOR WOULD TRY TO REMOVE CEMENT. SOMETIMES IT WOULD WORK FOR 10-11 SECONDS OR 10 MINUTES THEN WOULD STOP. THEY WOULD HAVE TO IT TURN OFF AND ON THE GENERATOR AND EVENTUALLY WOULD WORK BUT ONLY INTERMITTENTLY. TOWARDS THE END OF THE SURGERY, IT DID START TO WORK. THE COMPLAINT REPORT FORM ALSO INDICATED: THE DEVICE FAILURE DID NOT HAVE ANY ADVERSE EFFECTS ON PATIENT; THE INITIAL SURGERY WAS COMPLETED WITH THE DEVICE; THE EVENT LED TO A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE SURGICAL PROCEDURE: 2 TO 3 HOURS DELAY. 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: UNKNOWN. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    855222 SINGLE USE 8MM PIERCER PROBE - STERILE SINGLE USE 8MM PIERCER PROBE - STERILE JDX ORTHOFIX SRL OHP2080SU WO/19983/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention