ANALYSIS OF HISTORICAL RECORDS ORTHOFIX (B)(4) CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE DEVICE CODE OHS2080SU, LOT B1255002 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2018, WAS COMPRISED OF (B)(4) DEVICES. ALL OF THEM HAVE ALREADY BEEN RELEASED TO THE MARKET. ACCORDING TO ORTHOFIX (B)(4) HISTORICAL RECORDS, THIS IS THE FIRST NOTIFICATION RECEIVED FROM THIS SPECIFIC DEVICE LOT. TECHNICAL EVALUATION: THE DEVICE INVOLVED IN THIS EVENT HAS NOT BEEN RECEIVED AT ORTHOFIX (B)(4) YET. THE TECHNICAL EVALUATION WILL BE PERFORMED ONCE THE DEVICE IS RETURNED. 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 TECHNICAL INVESTIGATION ARE AVAILABLE. AS SOON AS THE RESULTS OF THE INVESTIGATION BECOME AVAILABLE, ORTHOFIX (B)(4) WILL PROVIDE YOU WITH A FOLLOW UP REPORT. ORTHOFIX (B)(4) CONTINUES MONITORING THE DEVICES ON THE MARKET.
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Patient 1
THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6); SURGEON'S NAME: DR. (B)(6); DATE OF SURGERY: (B)(6) 2018; BODY PART TO WHICH DEVICE WAS APPLIED: FEMUR; PATIENT INFORMATION: (B)(6) YEAR-OLD, FEMALE, PREVIOUS HEALTH CONDITION: INTERVENTION ON PTH PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE; TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM; EVENT DESCRIPTION: (B)(6)-YEAR-OLD PATIENT MANAGED FOR PTH REVISION FOR STEM LOOSENING. THE ABLATION OF THE CEMENT IS CARRIED OUT WITH THE OSCAR ABLATION SYSTEM FROM ORTHOFIX. THE DEVICE "SCRAPPER PROBE" BROKE IN THE FEMUR OF THE PATIENT. THE HEAD OF THE DEVICE REMAINED STUCK IN THE FEMORAL SHAFT. THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT: LONGER INTERVENTION TIME. RISK OF HAVING TO PERFORM A FEMOROTOMY IF THE HEAD OF THE DEVICE COULD NOT BE REMOVED. THE SURGERY WAS NOT COMPLETED WITH THE DEVICE. THE EVENT LED TO A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE SURGICAL PROCEDURE: LONGER INTERVENTION TIME. 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. ON (B)(4) 2018, THE LOCAL DISTRIBUTOR PROVIDED A COPY OF X-RAY IMAGES TAKEN ON (B)(6) 2018 AND THE FOLLOWING FURTHER INFORMATION: PATIENT'S WEIGHT AND HEIGHT: (B)(6). PROLONGATION OF SURGERY TIME: 30 MIN. THE HEAD OF THE PROBE HAD BEEN PUT OFF WITH HARD CONDITIONS. PATIENT'S CURRENT HEALTH CONDITION: POST OPERATIVE SITUATION HAS BEEN SIMPLE AND PATIENT WENT OUT FROM HOSPITAL BY (B)(6) 2018. (B)(4).