BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CEMENT REMOVAL HANDSET

    MDR report key: 7698225 · Received July 18, 2018

    Report

    Report Number
    9680825-2018-00064
    Event Type
    Injury
    Date Received
    July 18, 2018
    Date of Event
    June 22, 2018
    Report Date
    August 16, 2018
    Manufacturer
    ORTHOFIX SRL
    Product Code
    JDX
    PMA / PMN Number
    K093805
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    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. THE DEVICES INVOLVED IN THIS EVENT WERE MANUFACTURED BY ORTHOSONICS LTD. TECHNICAL EVALUATION: THE RETURNED DEVICES, RECEIVED ON JULY 31ST, 2018, WERE EXAMINED BY ORTHOFIX SRL QUALITY ENGINEERING DEPARTMENT. THE 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: 1). THE CEMENT REMOVAL HANDSET, DEVICE CODE OH300/2 BATCH 3H0126 IS FUNCTIONING PROPERLY. (MFR REPORT 9680825-2018-00063). 2). THE CEMENT REMOVAL HANDSET, DEVICE CODE OH300/02 BATCH 3H0038 IS FUNCTIONING PROPERLY. (MFR REPORT). 3). THE ULTRASONIC GENERATOR, DEVICE CODE OS3000 SERIAL NUMBER 3G019 IS NOT FUNCTIONING PROPERLY. ONE OF THE CABLES TIE ON THE CHANNEL 1 OF THE POWER BOARD IS CUT. THIS CAUSED A BAD CONNECTION OF THE BOARD TO THE REAR PANEL AND NO POWER TRANSMISSION TO THE HANDSETS. (MFR REPORT 9680825-2018-00074) THE RESULTS OF THE TECHNICAL EVALUATION CONCLUDED AS FOLLOWS: 1). THE CEMENT REMOVAL HANDSET, DEVICE CODE OH300/2 BATCH 3H0126 IS FUNCTIONING PROPERLY. 2). THE CEMENT REMOVAL HANDSET, DEVICE CODE OH300/02 BATCH 3H0038 IS FUNCTIONING PROPERLY. 3). THE FAILURE FOUND ON THE ULTRASONIC GENERATOR, DEVICE CODE OS3000 SERIAL NUMBER (B)(6) IS MOST LIKELY ATTRIBUTABLE TO INCORRECT HANDLING DURING REVISION OR SUBSEQUENT TAMPERING OF THE DEVICE. MEDICAL EVALUATION: THE INFORMATION MADE AVAILABLE ON THE CASE WAS SENT TO OUR MEDICAL EVALUATOR. PLEASE FIND BELOW AN EXTRACT OF THE MEDICAL EVALUATION PERFORMED. "IN THIS EVENT THE PATIENT WAS HAVING A HIP PROSTHESIS REVISION. THE TWO AVAILABLE HANDSETS DID NOT WORK, AND THE SURGEON HAD TO WAIT FOR ANOTHER HANDSET TO BE PROVIDED, WHICH TOOK 30 MINUTES. THE OPERATION THEN PROCEEDED AS PLANNED. THIS IS DIFFICULT, BUT I THINK THAT 30 MINUTES IS A SIGNIFICANT DELAY, AND I GUESS THAT MAKES THIS CASE REPORTABLE. 30 MINUTES IS QUITE A LONG ADDITIONAL TIME FOR THE WOUND TO BE OPEN". FINAL COMMENTS: 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. THE RESULTS OF THE TECHNICAL EVALUATION CONCLUDED AS FOLLOWS: 1). THE CEMENT REMOVAL HANDSET, DEVICE CODE OH300/2 BATCH 3H0126 IS FUNCTIONING PROPERLY. 2). THE CEMENT REMOVAL HANDSET, DEVICE CODE OH300/02 BATCH 3H0038 IS FUNCTIONING PROPERLY. 3). THE FAILURE FOUND ON THE ULTRASONIC GENERATOR, DEVICE CODE OS3000 SERIAL NUMBER (B)(6) IS MOST LIKELY ATTRIBUTABLE TO INCORRECT HANDLING DURING REVISION OR SUBSEQUENT TAMPERING OF THE DEVICE. THE MEDICAL EVALUATION CONFIRMED THAT 30 MINUTES DELAY HAS TO BE CONSIDERED AS CLINICALLY SIGNIFICANT. BASED ON THE RESULTS OF THE TECHNICAL EVALUATION, WHICH CONFIRMED THE HANDSETS CONFORMITY, AND ON THE EVIDENCES DERIVING FROM THE MEDICAL EVALUATION, ORTHOFIX SRL CAN CONCLUDE THAT THE PROBLEM THAT OCCURRED IS DUE TO INCORRECT HANDLING/TAMPERING OF THE GENERATOR. ORTHOFIX SRL CONTINUES MONITORING THE DEVICES ON THE MARKET.

    Description of Event or Problem · 0

    THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6), SURGEON NAME: (B)(6), DATE OF INITIAL SURGERY: (B)(6) 2018, BODY PART TO WHICH DEVICE WAS APPLIED: HIP, SURGERY DESCRIPTION: REVISION HIP, PATIENT INFORMATION: N.A., PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE, TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM, EVENT DESCRIPTION: SURGEON COULD NOT GET 2 OUT OF 3 HANDSET WORK, CHANGED CABLES AND FEEL IT IS THE HANDPIECES NOT THE CABLES THAT ARE AT FAULT. THE COMPLAINT REPORT FORM ALSO INDICATED: THE DEVICE FAILURE HAD NO ADVERSE EFFECTS ON PATIENT; THE INITIAL SURGERY WAS COMPLETED WITH THE DEVICE; A REPLACEMENT DEVICE WAS IMMEDIATELY AVAILABLE TO COMPLETE SURGERY; THE EVENT LED TO A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE SURGICAL PROCEDURE: TIME TO INTERCHANGE THE HANDSETS, APPROX 30 MINUTES; 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: N/A. MANUFACTURER REFERENCE NUMBER: (B)(4). DISTRIBUTOR REFERENCE NUMBER: (B)(4). (PLEASE KINDLY REFER ALSO TO MFR REPORTS 9680825-2018-00063 AND 9680825-2018-00074).

    Additional Manufacturer Narrative · 1

    IN 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. (ITEMS INVOLVED IN THIS EVENT WERE MANUFACTURED BY ORTHOSONICS LTD). TECHNICAL EVALUATION: THE DEVICES HAVE NOT BEEN RECEIVED YET BY ORTHOFIX (B)(4). THE TECHNICAL EVALUATION WILL BE PERFORMED AS SOON AS DEVICES BECOME AVAILABLE. MEDICAL EVALUATION: THE INFORMATION 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 INVESTIGATION ARE AVAILABLE. AS SOON AS THE RESULTS OF THE INVESTIGATION ARE AVAILABLE, ORTHOFIX (B)(4) WILL PROVIDE A FOLLOW UP REPORT. ORTHOFIX (B)(4) CONTINUES MONITORING THE DEVICES ON THE MARKET. (PLEASE KINDLY REFER ALSO TO MFR REPORT 9680825-2018-00063). [(B)(4)].

    Description of Event or Problem · 1

    THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6); SURGEON NAME: (B)(6); DATE OF INITIAL SURGERY: (B)(6) 2018; BODY PART TO WHICH DEVICE WAS APPLIED: HIP; SURGERY DESCRIPTION: REVISION HIP; PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE; TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: SURGEON COULDN'T GET 2 OUT OF 3 HANDSET WORK, CHANGED CABLES AND FEEL IT IS THE HANDPIECES NOT THE CABLES THAT ARE AT FAULT. THE COMPLAINT REPORT FORM ALSO INDICATED: THE DEVICE FAILURE HAD NO ADVERSE EFFECTS ON PATIENT; THE INITIAL SURGERY WAS COMPLETED WITH THE DEVICE; A REPLACEMENT DEVICE WAS IMMEDIATELY AVAILABLE TO COMPLETE SURGERY; THE EVENT LED TO A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE SURGICAL PROCEDURE: TIME TO INTERCHANGE THE HANDSETS, APPROX 30 MINUTES; 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. (B)(4). (PLEASE KINDLY REFER ALSO TO MFR REPORT 9680825-2018-00063).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539376 CEMENT REMOVAL HANDSET CEMENT REMOVAL HANDSET JDX ORTHOFIX SRL OH300/2 3H0038

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention