BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TITANIUM LOW PROFILE SCREW, D 5MM L 22.5MM

    MDR report key: 8539326 · Received April 23, 2019

    Report

    Report Number
    9680825-2019-00028
    Event Type
    Malfunction
    Date Received
    April 23, 2019
    Date of Event
    March 26, 2019
    Report Date
    May 28, 2019
    Manufacturer
    ORTHOFIX SRL
    Product Code
    HSB
    UDI-DI
    18054242511564
    PMA / PMN Number
    K141571
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYSIS OF HISTORICAL RECORDS: ORTHOFIX SRL CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE DEVICE CODE 99-T774022 LOT B1123301 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2017, WAS COMPRISED OF 74 DEVICES. 71 OF THEM HAVE ALREADY BEEN RELEASED TO THE MARKET. ACCORDING TO ORTHOFIX SRL HISTORICAL RECORDS, THIS IS THE FIRST NOTIFICATION RECEIVED FROM THIS SPECIFIC DEVICE LOT. ORTHOFIX SRL CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE DEVICE CODE 177301 LOT 01038332 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOTS, MANUFACTURED IN DIFFERENT SEMI-FINISHED LOTS BETWEEN YEAR 2013 AND YEAR 2017, WERE COMPRISED OF 110 DEVICES. 96 OF THEM HAVE ALREADY BEEN RELEASED TO THE MARKET. ACCORDING TO ORTHOFIX SRL HISTORICAL RECORDS, THIS IS THE FIRST NOTIFICATION RECEIVED FROM THIS SPECIFIC DEVICE LOT. TECHNICAL EVALUATION: ORTHOFIX SRL RECEIVED FROM THE DISTRIBUTOR, ON 12 APRIL 2019 THE TWO LOCKING DRIVER CODE 177301 BATCH 01038332, WHICH WERE PART OF THE INSTRUMENTATION SET USED IN THE SURGERY. AS IT WAS NOT POSSIBLE TO IDENTIFY THE DRIVER, WHICH HAD PROBLEMS WITH THE SCREW, THE HOSPITAL RETURNED BOTH OF THEM. THE SCREW CODE REFERENCE 99-T774022 AND THE NAIL CODE REFERENCE 99-T77120 TITANIUM ANKLE HINDFOOT NAIL 11/200, LOT B1259321 WERE NOT RETURNED AS IMPLANTED ON PATIENT. THE LOCKING DRIVERS WERE EXAMINED BY ORTHOFIX SRL QUALITY ENGINEERING AREA. THE VISUAL CHECK DID NOT EVIDENCE ANY ANOMALIES. THE BLACK MARK AND THE LASER MARKING REPORTING THE PRODUCT CODE AND THE BATCH NUMBER ARE STILL PRESENT. THE DIMENSIONAL CHECK DID NOT EVIDENCE ANY ANOMALIES. THE FUNCTIONAL CHECK PERFORMED USING A GO/NO GO GAUGE DID NOT SHOW ANY ANOMALIES. MEDICAL EVALUATION: THE INFORMATION MADE AVAILABLE ON THE CASE TOGETHER WITH THE RESULTS OF THE TECHNICAL EVALUATION WERE SENT TO OUR MEDICAL EVALUATOR. PLEASE FIND BELOW AN EXTRACT OF THE MEDICAL EVALUATION PERFORMED. (B)(6) 2019: IN THIS CASE A 30 YEAR OLD FEMALE PATIENT WAS HAVING AN AHN NAIL INSERTED INTO HER LEFT LEG. FROM THE MINIMAL INFORMATION PROVIDED IT SEEMS THAT THE SURGEON WAS UNABLE TO LOCK THE TALAR SCREW AFTER INSERTION. SOME DELAY WAS CAUSED, UP TO 30 MINUTES, AND THE SCREW COMPRESSION WAS CONSIDERED "STRONG ENOUGH". WE HAVE TO WAIT AND SEE REGARDING THE TECHNICAL ANALYSIS. 7 MAY 2019 WITH THE OUTCOME OF THE TECHNICAL ANALYSIS THIS IS A VERY CLEAR TECHNICAL ANALYSIS WITH A GOOD DESCRIPTION OF THE INSTRUMENTS. THE CONCLUSIONS ARE AS FOLLOWS: 2 LOCKING DRIVERS WERE RETURNED; IT WAS NOT STATED WHICH OF THESE CAUSED THE PROBLEMS IN THE OPERATION BOTH OF THE LOCKING DRIVERS WERE FULLY INSPECTED AND TESTED. BOTH OF THEM WERE FOUND TO BE WITHIN SPECIFICATION WITH NORMAL FUNCTION. WITHOUT MORE INFORMATION IT IS NOT POSSIBLE TO STATE WHY THIS STEP IN THE OPERATION DID NOT GO ACCORDING TO PLAN. WE NEED MORE INFORMATION TO TRY TO UNDERSTAND WHY THIS HAPPENED. I AGREE WITH THE CONCLUSIONS OF THE TECHNICAL ANALYSIS. FINAL COMMENTS: THE RESULTS OF THE TECHNICAL EVALUATION CONFIRMED THAT BOTH LOCKING DRIVERS RETURNED ARE CONFORMING TO DESIGN SPECIFICATIONS. IT WAS NOT POSSIBLE TO REPLICATE THE FAILURE NOTIFIED AS BOTH LOCKING DRIVERS STILL PERFORM PROPERLY. NO ANOMALIES WERE DETECTED. THE NAIL AND THE SCREW WERE NOT RETURNED AS ON PATIENT. THE CAUSE OF THE FAILURE IN ENGAGING BETWEEN THE DRIVER AND THE LOCKING MECHANISM REMAINS UNKNOWN. ORTHOFIX SRL HISTORICAL RECORDS SHOWS THAT NO OTHER NOTIFICATIONS HAVE BEEN RECEIVED IN REGARDS TO THESE SPECIFIC DEVICES LOT. ORTHOFIX SRL CONTINUES MONITORING THE DEVICES ON THE MARKET. PLEASE KINDLY REFER ALSO TO MFR REPORT NUMBER 9680825-2019-00027 FOLLOW UP 1.

    Description of Event or Problem · 0

    THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6). SURGEON'S NAME: DR. (B)(6). DATE OF INITIAL SURGERY: (B)(6) 2019 BODY PART TO WHICH DEVICE WAS APPLIED: FOOT/ANKLE/TIBIA LEFT. SURGERY DESCRIPTION: N/A. PATIENT INFORMATION: 30 YEAR-OLD, FEMALE, WEIGHT NORMAL. PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE . TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: DRIVER FOR LOCKING THE TALUS SCREW FOUND NO CONTACT TO LOCK IT. THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT, THE INITIAL SURGERY WAS COMPLETED WITH THE DEVICE AN ADDITIONAL SURGERY WAS NOT REQUIRED FOLLOWING DEVICE FAILURE, 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. FURTHER INFORMATION RECEIVED FROM THE DISTRIBUTOR ON 27 MARCH 2019: THE SURGERY COULD BE ENDED WELL. THE SURGERY PROCEDURE LASTED ½ HOUR MORE. X-RAYS AND PATIENT CURRENT HEALTH CONDITION ARE REQUESTED. THE COMPRESSION OF THE SCREW WAS STRONG ENOUGH TO HOLD THE SCREW IN PLACE. NAIL AND SCREW ARE IN THE PATIENT. FURTHER INFORMATION RECEIVED FROM THE DISTRIBUTOR ON 10 APRIL 2019: THE PATIENT CONDITION IS FINE. THE SURGEON WILL ASK THE PATIENT IF WE CAN PROVIDE THE XRAYS. IF THE PATIENT AGREES HE WILL SEND THEM. FURTHER INFORMATION RECEIVED FROM THE DISTRIBUTOR ON 7 MAY APRIL 2019 ANSWERING THE FOLLOWING MEDICAL EVALUATOR QUESTIONS: DID THE SURGEON CHECK THE POSITION OF THE LOCKING MECHANISM BEFORE INSERTING THE NAIL? YES. DID HE/SHE USE THE LOCKING DRIVER AT THIS POINT TO ADJUST THE POSITION OF THE LOCKING / COMPRESSION MECHANISM (AS DESCRIBED ON PAGE 15 OF THE MANUAL)? YES. WHAT EXACTLY HAPPENED WHEN THE SURGEON TRIED TO LOCK THE TALAR SCREW? HE COULD NOT CONNECT THE DRIVER WITH THE SCREW TO LOCK. HAD THE SURGEON USED AN AHN BEFORE AND IF SO DID THE LOCKING MECHANISM WORK NORMALLY ON THAT OCCASION? NO. MANUFACTURER REFERENCE NUMBER: (B)(4). DISTRIBUTOR REFERENCE NUMBER: N/A. PLEASE KINDLY REFER ALSO TO MFR REPORT NUMBER 9680825-2019-00027 FOLLOW UP 1.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF HISTORICAL RECORDS: ORTHOFIX (B)(4) CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE DEVICE CODE 99-T774022 LOT B1123301 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2017, WAS COMPRISED OF 74 DEVICES. 71 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. ORTHOFIX (B)(4) CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE DEVICE CODE 177301 LOT 01038332 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOTS, MANUFACTURED IN DIFFERENT SEMI-FINISHED LOTS BETWEEN YEAR 2013 AND YEAR 2017, WERE COMPRISED OF 110 DEVICES. 96 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 SCREW INVOLVED IN THIS EVENT WAS NOT RETURNED AS IT WAS IMPLANTED ON PATIENT. THE DRIVER INVOLVED WAS RECEIVED BY ORTHOFIX (B)(4) ON 12 APRIL, 2019. THE TECHNICAL EVALUATION IS IN PROGRESS. 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 INVESTIGATION 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 9680825-2019-00027.

    Description of Event or Problem · 1

    THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6). SURGEON'S NAME: DR. (B)(6). DATE OF INITIAL SURGERY: (B)(6) 2019. BODY PART TO WHICH DEVICE WAS APPLIED: FOOT/ANKLE/TIBIA LEFT. SURGERY DESCRIPTION: N/A. PATIENT INFORMATION: (B)(6) YEAR-OLD, FEMALE, WEIGHT NORMAL. PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: DRIVER FOR LOCKING THE TALUS SCREW FOUND NO CONTACT TO LOCK IT. THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT. THE INITIAL SURGERY WAS COMPLETED WITH THE DEVICE. AN ADDITIONAL SURGERY WAS NOT REQUIRED FOLLOWING DEVICE FAILURE. 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. FURTHER INFORMATION RECEIVED FROM THE DISTRIBUTOR ON (B)(6) 2019: THE SURGERY COULD BE ENDED WELL. THE SURGERY PROCEDURE LASTED ½ HOUR MORE. X-RAYS AND PATIENT CURRENT HEALTH CONDITION ARE REQUESTED. THE COMPRESSION OF THE SCREW WAS STRONG ENOUGH TO HOLD THE SCREW IN PLACE. NAIL AND SCREW ARE IN THE PATIENT. FURTHER INFORMATION RECEIVED FROM THE DISTRIBUTOR ON (B)(6) 2019: THE PATIENT CONDITION IS FINE. THE SURGEON WILL ASK THE PATIENT IF WE CAN PROVIDE THE X-RAYS. IF THE PATIENT AGREES HE WILL SEND THEM. MANUFACTURER REFERENCE NUMBER: (B)(4). DISTRIBUTOR REFERENCE NUMBER: N/A. PLEASE KINDLY REFER ALSO TO MFR REPORT NUMBER 9680825-2019-00027

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332151 TITANIUM LOW PROFILE SCREW, D 5MM L 22.5MM TITANIUM LOW PROFILE SCREW, D 5MM L 22.5MM HSB ORTHOFIX SRL 99-T774022 B1123301 18054242511564

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR