BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRASONIC GENERATOR 230V CE

    MDR report key: 7529128 · Received May 21, 2018

    Report

    Report Number
    9680825-2018-00043
    Event Type
    Injury
    Date Received
    May 21, 2018
    Date of Event
    April 25, 2018
    Report Date
    June 15, 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 MAY 3RD, 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 ULTRASONIC GENERATOR, DEVICE CODE OS3000 SERIAL NUMBER (B)(4) IS FUNCTIONING PROPERLY. 2). THE CEMENT REMOVAL HANDSET, DEVICE CODE OH300/2 BATCH 3H0251, IS NOT FUNCTIONING PROPERLY. THE SEALING IS LOST FROM THE REAR BODY SEAL, THEREFORE THE HANDSET DOES NOT WORK. (MFR 9680825-2018-00050). 3). THE CEMENT REMOVAL HANDSET, DEVICE CODE OH300/02 BATCH 3H0255, IS NOT FUNCTIONING PROPERLY. THE CERAMICS INSIDE ARE BROKEN. THE HANDSET DOES NOT WORK. (MFR 9680825-2018-00051) THE RESULTS OF THE TECHNICAL EVALUATION CONCLUDED AS FOLLOWS: 1). THE ULTRASONIC GENERATOR, DEVICE CODE OS3000 SERIAL NUMBER (B)(4) IS FUNCTIONING PROPERLY. 2). THE FAILURE FOUND ON THE CEMENT REMOVAL HANDSET, DEVICE CODE OH300/2 BATCH 3H0251, 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 O-RINGS. (MFR 9680825-2018-00050). 3). THE FAILURE FOUND ON THE CEMENT REMOVAL HANDSET, DEVICE CODE OH300/2 BATCH 3H0255, IS MOST LIKELY ATTRIBUTABLE TO A NORMAL WEAR AND TEAR OF THE INTERNAL CERAMICS. (MFR 9680825-2018-00051). 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. "IT SEEMS THAT IN THIS CASE AN OSCAR GENERATOR WAS WORKING BUT DID NOT SEEM TO BE PROVIDING FULL POWER. THE CAUSE OF THIS WAS NOT CLEAR. AS A RESULT THE OPERATION WAS COMPLETED AS PLANNED BUT TOOK AN ADDITIONAL 45 MINUTES. I FULLY AGREE THAT THIS IS A 'SERIOUS INJURY' AND THAT IT MUST BE REPORTED AS YOU ARE INTENDING". 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 ULTRASONIC GENERATOR, DEVICE CODE OS3000 SERIAL NUMBER (B)(4) IS FUNCTIONING PROPERLY. 2). THE FAILURE FOUND ON THE CEMENT REMOVAL HANDSET, DEVICE CODE OH300/2 BATCH 3H0251, 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 O-RINGS. (MFR 9680825-2018-00050). 3). THE FAILURE FOUND ON THE CEMENT REMOVAL HANDSET, DEVICE CODE OH300/2 BATCH 3H0255, IS MOST LIKELY ATTRIBUTABLE TO A NORMAL WEAR AND TEAR OF THE INTERNAL CERAMICS. (MFR 9680825-2018-00051). THE MEDICAL EVALUATION CONFIRMED THAT 45 MINUTES DELAY HAS TO BE CONSIDERED AS CLINICALLY SIGNIFICANT. 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. PLEASE ALSO KINDLY REFER TO MFR REPORTS 9680825-2018-00050 AND 9680825-2018-00051. ATTACHMENT: [(B)(4)_FDA MEDWATCH COVER LETTER_FOLLOW UP 1.PDF].

    Description of Event or Problem · 0

    THE INFORMATION INITIALLY PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6); SURGEON NAME: MR (B)(6); DATE OF SURGERY: (B)(6) 2018; BODY PART TO WHICH DEVICE WAS APPLIED: HIP; SURGERY DESCRIPTION: NOT APPLICABLE; PATIENT INFORMATION: N.A.; PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE; TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: "REPORTED BY (B)(6); GENERATOR IS NOT WORKING FULLY, SEEMS TO WORK SLOWLY AND NOT AT FULL POWER. DESCRIBED BY SURGEON THAT THE HANDSET "WOULDN'T EVEN HEAT WATER' LOOSE WIRE PERHAPS?" THE COMPLAINT REPORT FORM ALSO INDICATED: THE INITIAL SURGERY WAS COMPLETED WITH THE DEVICE; THE EVENT LED TO A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE SURGICAL PROCEDURE (EXTRA 45 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 XRAY IMAGES ARE NOT AVAILABLE; PATIENT CURRENT HEALTH CONDITIONS: NO RESPONSE. ON MAY 16, 2018, ORTHOFIX SRL RECEIVED THE REVISED COMPLAINT REPORT FORM WHICH INCLUDED THE FOLLOWING INFORMATION: HOSPITAL NAME: (B)(6); SURGEON NAME: MR (B)(6); DATE OF SURGERY: (B)(6) 2018; BODY PART TO WHICH DEVICE WAS APPLIED: HIP; SURGERY DESCRIPTION: OTHER (1ST STAGE REVISION HIP OPERATION) PATIENT INFORMATION: N.A.; PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE; TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: "1ST STAGE REVISION HIP OPERATION REPORTED BY (B)(6); GENERATOR IS NOT WORKING FULLY, SEEMS TO WORK SLOWLY AND NOT AT FULL POWER. DESCRIBED BY SURGEON THAT THE HANDSET "WOULDN'T EVEN HEAT WATER' LOOSE WIRE PERHAPS? ALTHOUGH THE MODULE AND HANDSETS APPEARS TO SYNCHRONIZE INDEPENDENTLY, WHEN THE PROBE WAS PLACED WITHIN THE FEMORAL CAVITY THE HANDSETS GENERATED NO POWER AND MODULE FREQUENCY WOULD NOT PICK UP". THE COMPLAINT REPORT FORM ALSO INDICATES: 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 (EXTRA 45 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 XRAY IMAGES ARE NOT AVAILABLE; PATIENT CURRENT HEALTH CONDITIONS: NO RESPONSE. (B)(4).

    Additional Manufacturer Narrative · 1

    ON (B)(6) 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 DEVICE INVOLVED IN THIS EVENT WAS MANUFACTURED BY ORTHOSONICS LTD. TECHNICAL EVALUATION: THE DEVICE CONCERNED WAS RECEIVED BY ORTHOFIX SRL ON (B)(6) 2018. THE TECHNICAL EVALUATION ON THE RETURNED DEVICE IS CURRENTLY ON GOING. 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 SRL WILL PROVIDE A FOLLOW UP REPORT. ORTHOFIX SRL CONTINUES MONITORING THE DEVICES ON THE MARKET.

    Description of Event or Problem · 1

    THE INFORMATION INITIALLY PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6); SURGEON NAME: (B)(6); DATE OF SURGERY: (B)(6) 2018; BODY PART TO WHICH DEVICE WAS APPLIED: HIP; SURGERY DESCRIPTION: NOT APPLICABLE; PATIENT INFORMATION: N.A.; PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE; TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: "REPORTED BY KELVIN REED - GENERATOR IS NOT WORKING FULLY, SEEMS TO WORK SLOWLY AND NOT AT FULL POWER. DESCRIBED BY SURGEON THAT THE HANDSET "WOULDN'T EVEN HEAT WATER' LOOSE WIRE PERHAPS?" THE COMPLAINT REPORT FORM ALSO INDICATED: THE INITIAL SURGERY WAS COMPLETED WITH THE DEVICE; THE EVENT LED TO A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE SURGICAL PROCEDURE (EXTRA 45 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: NO RESPONSE. ON (B)(6) 2018, ORTHOFIX SRL RECEIVED THE REVISED COMPLAINT REPORT FORM WHICH INCLUDED THE FOLLOWING INFORMATION: HOSPITAL NAME: (B)(6). SURGEON NAME: (B)(6); DATE OF SURGERY: (B)(6) 2018; BODY PART TO WHICH DEVICE WAS APPLIED: HIP; SURGERY DESCRIPTION: OTHER (1ST STAGE REVISION HIP OPERATION) PATIENT INFORMATION: N.A.; PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE; TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: "1ST STAGE REVISION HIP OPERATION REPORTED BY KELVIN REED - GENERATOR IS NOT WORKING FULLY, SEEMS TO WORK SLOWLY AND NOT AT FULL POWER. DESCRIBED BY SURGEON THAT THE HANDSET "WOULDN'T EVEN HEAT WATER' LOOSE WIRE PERHAPS? ALTHOUGH THE MODULE AND HANDSETS APPEARS TO SYNCHRONIZE INDEPENDENTLY, WHEN THE PROBE WAS PLACED WITHIN THE FEMORAL CAVITY THE HANDSETS GENERATED NO POWER AND MODULE FREQUENCY WOULD NOT PICK UP". THE COMPLAINT REPORT FORM ALSO INDICATES: 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 (EXTRA 45 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: NO RESPONSE. MANUFACTURER REFERENCE NUMBER: (B)(4). DISTRIBUTOR REFERENCE NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373561 ULTRASONIC GENERATOR 230V CE ULTRASONIC GENERATOR 230V CE JDX ORTHOFIX SRL OS3000 3G126

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention