BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CEMENT REMOVAL HANDSET

    MDR report key: 7124872 · Received December 18, 2017

    Report

    Report Number
    9680825-2017-00072
    Event Type
    Injury
    Date Received
    December 18, 2017
    Date of Event
    November 14, 2017
    Report Date
    January 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

    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. (ITEM INVOLVED IN THIS EVENT WAS MANUFACTURED BY ORTHOSONICS LTD). TECHNICAL EVALUATION THE RETURNED DEVICES, RECEIVED ON 27TH NOVEMBER 2017 WERE EXAMINED BY ORTHOFIX (B)(4) QUALITY ENGINEERING DEPARTMENT. -ULTRASONIC GENERATOR S/N (B)(4): THE VISUAL CHECK DID NOT EVIDENCE ANY ANOMALIES. THE FUNCTIONAL CHECK CONFIRMED THAT THE GENERATOR IS NOT FUNCTIONING PROPERLY. ON THE POWER BOARD 1 AND 2, THE CONTROL BOARD L2 WAS NOT PROPERLY FIXED. THE FAILURE OCCURRED IS MOST LIKELY TO BE ATTRIBUTABLE AN INCORRECT HANDLING AS BUMPS AND VIBRATIONS DURING TRANSPORT. THIS CAUSED THE ELECTRICAL COMPONENTS BREAKAGE. -CEMENT REMOVAL HANDSETS S/N (B)(4): THE VISUAL CHECK DID NOT EVIDENCE ANY ANOMALIES. THE FUNCTIONAL CHECK PERFORMED CONFIRMED THAT BOTH HANDSETS STILL PERFORM PROPERLY. MEDICAL EVALUATION THE INFORMATION MADE AVAILABLE ON THE CASE TOGETHER WITH THE RESULTS OF THE TECHNICAL INVESTIGATION WAS SENT TO OUR MEDICAL EVALUATOR. PLEASE FIND BELOW AN EXTRACT OF THE MEDICAL EVALUATION: 5 DECEMBER 2017 THIS PATIENT IS A MAN OF (B)(6) YEARS, OTHERWISE FIT. WE ARE NOT GIVEN THE COMPLETE STORY, AS YOU SAY. WE KNOW THAT THE PATIENT WAS TO HAVE A FEMORAL IMPLANT THAT REQUIRED CEMENT. THIS PROCEDURE FAILED, FOR REASONS NOT STATED. THE SURGEON WISHED TO REMOVE THE INSERTED CEMENT FROM THE FEMORAL CANAL. WE ARE NOT TOLD THE LOCATION OF THE CEMENT OR THE PATHOLOGY, BUT I GUESS THAT IT IS NOT RELEVANT FOR THE BASIS OF THE COMPLAINT. THE PROBLEM WAS THAT WHEN THEY CAME TO USE OSCAR TO REMOVE THE CEMENT, NEITHER OF THE TWO HANDSETS WORKED. THEY THEREFORE USED MECHANICAL REAMERS TO REMOVE INTRA-FEMORAL CEMENT. THESE ARE NOT THE SAME REAMERS USED TO WIDEN THE MEDULLARY CANAL, BUT ARE DESIGNED SPECIFICALLY TO REAM CEMENT. TO HELP OUR UNDERSTANDING OF WHAT WAS PROPOSED AND WHAT HAPPENED, IT WOULD BE USEFUL TO HEAR WHAT THE SURGICAL PROCEDURE WAS AND WHAT THE OUTCOME WAS. THE BRIEF NOTE IMPLIES THAT THE OPERATION WAS COMPLETED SUCCESSFULLY, BUT WE DO NOT KNOW THIS. SOME IMAGES OF THE PROCEDURE WOULD BE USEFUL. 28 DECEMBER 2017 WITH THE OUTCOME OF THE TECHNICAL ANALYSIS THIS TECHNICAL ANALYSIS MAKES IT CLEAR THAT THE REASON FOR THE FAILURE OF THE OSCAR EQUIPMENT IN THIS EVENT WAS DUE TO INTERNAL DAMAGE TO POWER BOARDS 1 AND 2, RESULTING IN A FAILURE TO FUNCTION. THE CAUSE OF THE DAMAGED POWER BOARD IS ASSUMED TO BE INCORRECT HANDLING DURING TRANSPORT. THE TWO HAND SETS WORK NORMALLY. IT IS REASONABLE TO ASSUME THAT THERE HAS BEEN INCORRECT HANDLING. FINAL COMMENTS ORTHOFIX FAILURE ANALYSIS CAN CONCLUDE THAT THE DAMAGE OCCURRED ON THE GENERATOR S/N (B)(4) IS ATTRIBUTABLE TO POWER BOARD 1 AND 2, WHERE THE CONTROL BOARD L2 WAS NOT PROPERLY FIXED. THIS COULD BE DUE TO AN INCORRECT HANDLING AS BUMPS AND VIBRATIONS DURING TRANSPORT. THIS CAUSED THE ELECTRICAL COMPONENTS BREAKAGE. NO ANOMALIES WERE DETECTED ON CEMENT REMOVAL HANDSETS. THEY STILL PERFORM PROPERLY. THE ANALYSIS OF THE HISTORICAL DATA EVIDENCED THAT NO OTHER SIMILAR NOTIFICATIONS HAVE BEEN RECEIVED ON DEVICES BELONGING TO THE SAME LOT. ORTHOFIX (B)(4) CONTINUES MONITORING THE DEVICES ON THE MARKET. (PLEASE KINDLY REFER ALSO TO MFR REPORT 9680825-2017-00070 FOLLOW UP 1 AND MFR REPORT 9680825-2017-00071 FOLLOW UP 1) (B)(4).

    Description of Event or Problem · 0

    THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: - HOSPITAL NAME: (B)(6). - SURGEON'S NAME: MR. (B)(6). - DATE OF INITIAL SURGERY: (B)(6) 2017. - BODY PART TO WHICH DEVICE WAS APPLIED: FEMUR. - SURGERY DESCRIPTION: NA. - PATIENT INFORMATION: (B)(6) YEAR-OLD, MALE. - PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE. - TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. - EVENT DESCRIPTION: TWO HANDSETS FAILED, CONNECTION FAILURE, TRIED IN ALL MODULES, HANDSETS HAD NOT BEEN USED BEFORE AND WERE NOT HOT. OPERATION DETAILS: REMOVAL OF CEMENT FOLLOWING FAILED ATTEMPT AT PUTTING A FEMORAL IMPLANT INTO A FEMUR. THE COMPLAINT REPORT FORM ALSO INDICATES: - THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT - THE INITIAL SURGERY WAS NOT COMPLETED WITH THE DEVICE - A REPLACEMENT DEVICE WAS IMMEDIATELY AVAILABLE TO COMPLETE SURGERY: SOLUTION CANAL REAMERS - THE EVENT LED TO A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE SURGICAL PROCEDURE: SURGERY TOOK APPROX. 30MINS LONGER - AN ADDITIONAL SURGERY WAS NOT REQUIRED - A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED - COPIES OF THE OPERATIVE REPORTS ARE NOT AVAILABLE - COPIES OF THE X-RAY IMAGES ARE NOT AVAILABLE - PATIENT CURRENT HEALTH CONDITION: NA (B)(4). (PLEASE KINDLY REFER ALSO TO MFR REPORT 9680825-2017-00070 FOLLOW UP 1 AND MFR REPORT 9680825-2017-00071 FOLLOW UP 1)

    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. (ITEM INVOLVED IN THIS EVENT WAS MANUFACTURED BY ORTHOSONICS LTD). TECHNICAL EVALUATION: THE DEVICES CONCERNED WERE RECEIVED BY ORTHOFIX (B)(4) ON NOVEMBER 27, 2017. THE TECHNICAL EVALUATION ON THE RETURNED DEVICES 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 AND/OR FURTHER INFORMATION ARE AVAILABLE. ORTHOFIX (B)(4) HAS REQUESTED TO THE DISTRIBUTOR FURTHER INFORMATION ON THE EVENT, I.E. SURGERY DESCRIPTION, PATHOLOGY, OUTCOME OF THE SURGICAL PROCEDURE, IMAGES OF THE PROCEDURE. UNFORTUNATELY, THIS INFORMATION HAS NOT YET MADE AVAILABLE. AS SOON AS FURTHER INFORMATION ON THE CASE AND/OR THE OUTCOME OF THE TECHNICAL ANALYSIS IS 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 9680825-2017-00070 AND MFR REPORT 9680825-2017-00071).

    Description of Event or Problem · 1

    THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6) HOSPITAL; SURGEON'S NAME: MR. (B)(6); DATE OF INITIAL SURGERY: (B)(6) 2017; BODY PART TO WHICH DEVICE WAS APPLIED: FEMUR; SURGERY DESCRIPTION: NA; PATIENT INFORMATION: (B)(6) YEAR-OLD, MALE; PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE; TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: TWO HANDSETS FAILED, CONNECTION FAILURE, TRIED IN ALL MODULES, HANDSETS HAD NOT BEEN USED BEFORE AND WERE NOT HOT. OPERATION DETAILS: REMOVAL OF CEMENT FOLLOWING FAILED ATTEMPT AT PUTTING A FEMORAL IMPLANT INTO A FEMUR. THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT; THE INITIAL SURGERY WAS NOT COMPLETED WITH THE DEVICE; A REPLACEMENT DEVICE WAS IMMEDIATELY AVAILABLE TO COMPLETE SURGERY: SOLUTION CANAL REAMERS; THE EVENT LED TO A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE SURGICAL PROCEDURE: SURGERY TOOK APPROX. 30MINS LONGER; AN ADDITIONAL SURGERY WAS NOT REQUIRED. A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED; COPIES OF THE OPERATIVE REPORTS ARE NOT AVAILABLE; COPIES OF THE X-RAY IMAGES ARE NOT AVAILABLE; PATIENT CURRENT HEALTH CONDITION: NA. (B)(4). (PLEASE KINDLY REFER ALSO TO MFR REPORT 9680825-2017-00070 AND MFR REPORT 9680825-2017-00071).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    903904 CEMENT REMOVAL HANDSET CEMENT REMOVAL HANDSET JDX ORTHOFIX SRL OH300/2 3H0125

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention