BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE SCREW

    MDR report key: 6642660 · Received June 15, 2017

    Report

    Report Number
    9680825-2017-00042
    Event Type
    Injury
    Date Received
    June 15, 2017
    Report Date
    August 9, 2017
    Manufacturer
    ORTHOFIX SRL
    Product Code
    JDW
    PMA / PMN Number
    K974186
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF HISTORICAL RECORDS: NO INFORMATION HAS BEEN PROVIDED IN RELATION TO THE CODE REFERENCE AND LOT NUMBER OF THE BONE SCREWS AND OLIVE WIRE INVOLVED IN THIS EVENT. THEREFORE IT WAS NOT POSSIBLE TO PERFORM THE VERIFICATION OF THE HISTORICAL DATA. TECHNICAL EVALUATION: ON 11 JULY 2017 ORTHOFIX SRL RECEIVED A BROKEN PORTION OF ONE BONE SCREW (CODE AND LOT UNKNOWN). THE RETURNED PORTION OF SCREW WAS EXAMINED BY ORTHOFIX SRL QUALITY ENGINEERING AREA. THE DEVICE WAS SUBJECTED TO VISUAL CHECK AS PER ORTHOFIX SRL SPECIFICATION. THE VISUAL EXAMINATION HIGHLIGHTED THAT THE SCREW PORTION WAS DAMAGED DURING REMOVAL. THE BREAKAGE SURFACE OF THE SCREW PORTION IS TOO DAMAGED TO PERFORM FURTHER ANALYSIS. NO ANALYSIS OF HISTORICAL RECORDS COULD BE PERFORMED AS THE SCREW PORTION RETURNED WAS CUT AND DID NOT REPORT THE LASER MARKING OF THE LOT NUMBER. NO ADDITIONAL TECHNICAL EVALUATION COULD BE PERFORMED BECAUSE THE RETURNED ITEM IS TOO DAMAGED TO BE USED FOR TECHNICAL ASSESSMENTS. CONSIDERING THAT NO INFORMATION WAS PROVIDED ON THE EVENT AND THAT ONLY A DAMAGED PORTION OF A SCREW WAS PROVIDED, ORTHOFIX SRL COULD NOT IDENTIFY THE ROOT CAUSE OF THE DEVICES FAILURE. AS THE AFFECTED SECOND SCREW AND THE OLIVE WIRE (CODES REFERENCES AND LOT NUMBERS UNKNOWN) WERE NOT RETURNED IT WAS NOT POSSIBLE TO PERFORM THE TECHNICAL EVALUATION. MEDICAL EVALUATION: THE LITTLE INFORMATION AVAILABLE ON THE CASE WITH THE OUTCOME OF THE TECHNICAL ANALYSIS WAS SENT TO OUR MEDICAL EVALUATOR. (B)(6) 2017: "WE HAVE BEEN GRANTED THE ABSOLUTE MINIMUM OF INFORMATION IN THIS CASE, SIMPLY THAT 2 HALF PINS AND ONE OLIVE WIRE BROKE WHILE A MALE PATIENT OF (B)(6) YEARS WAS BEING TREATED FOR A CORRECTION. THERE ARE MANY POSSIBLE REASON FOR THIS, AND CURRENTLY WE HAVE NO DETAILS AT ALL OF THE PROCEDURE." 4 AUGUST 2017 WITH THE RESULTS OF THE TECHNICAL ANALYSIS: "IN SPITE OF PROMISES FOR FURTHER INFORMATION WE HAVE RECEIVED LESS THAN THE MINIMUM FOR A SATISFACTORY REPORT. I NOTE THAT THE SCREW BROKE PROBABLY AT THE POINT WHERE THE THREAD PASSED THROUGH THE BONE SURFACE, WHICH IS USUAL FOR THE RARE SCREW BREAKAGES THAT WE DO SEE. THIS TYPE OF BREAKAGE IS VERY UNUSUAL AND WE MUST ASSUME IN THE ABSENCE OF OTHER INFORMATION THAT THE CAUSE WAS TECHNICAL REASONS PARTICULAR TO THIS APPLICATION. NO FURTHER SENSIBLE COMMENT IS POSSIBLE." FINAL COMMENTS: NO INFORMATION HAS BEEN PROVIDED IN RELATION TO THE CODE REFERENCE AND LOT NUMBER OF THE BONE SCREWS AND OLIVE WIRE INVOLVED IN THIS EVENT. THEREFORE IT WAS NOT POSSIBLE TO PERFORM THE VERIFICATION OF THE HISTORICAL DATA. NO ANALYSIS OF HISTORICAL RECORDS COULD BE PERFORMED AS THE SCREW PORTION RETURNED WAS CUT AND DID NOT REPORT THE LASER MARKING OF THE LOT NUMBER. CONSIDERING THAT NO INFORMATION WAS PROVIDED ON THE EVENT AND THAT ONLY A DAMAGED PORTION OF A SCREW WAS PROVIDED, ORTHOFIX SRL COULD NOT IDENTIFY THE ROOT CAUSE OF THE DEVICES FAILURE. A COMPLETE MEDICAL EVALUATION WAS NOT POSSIBLE AS SOME INFORMATION REGARDING CODE AND LOT NUMBER OF THE DEVICES INVOLVED, TREATMENT PERFORMED, DETAILS ON THE ADDITIONAL SURGERY PERFORMED, COPY OF X-RAY IMAGES, PATIENT CURRENT HEALTH CONDITION WAS NOT PROVIDED. BASED ON THE INFORMATION AVAILABLE ON THE EVENT, IT WAS NOT POSSIBLE TO FINALIZE THE INVESTIGATION AND DETERMINE THE ROOT CAUSE OF THE EVENT NOTIFIED. IF FURTHER INFORMATION AND/OR THE OTHER DEVICES INVOLVED BECOME AVAILABLE, ORTHOFIX SRL WILL FINALIZE THE INVESTIGATION. ORTHOFIX SRL CONTINUES MONITORING THE DEVICES ON THE MARKET. PLEASE ALSO KINDLY REFER TO MFR REPORT 9680825-2017-00041 FOLLOW UP 1 AND MFR REPORT 9680825-2017-00043 FOLLOW UP 1.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF HISTORICAL RECORDS (PLEASE ALSO KINDLY REFER TO MFR REPORT 9680825-2017-00041 AND MFR REPORT 9680825-2017-00043). NO INFORMATION HAS BEEN PROVIDED IN RELATION TO THE CODE REFERENCE AND LOT NUMBER OF THE BONE SCREWS AND OLIVE WIRE INVOLVED IN THIS EVENT. THEREFORE IT WAS NOT POSSIBLE TO PERFORM THE VERIFICATION OF THE HISTORICAL DATA. TECHNICAL EVALUATION (PLEASE ALSO KINDLY REFER TO MFR REPORT 9680825-2017-00041 AND MFR REPORT 9680825-2017-00043). THE DEVICES INVOLVED IN THIS EVENT WERE NOT RETURNED TO ORTHOFIX (B)(4) FOR THE TECHNICAL EVALUATION. ORTHOFIX (B)(4) IS STRICTLY IN CONTACT WITH THE LOCAL DISTRIBUTOR TO HAVE THEM RETURNED FOR THE TECHNICAL EVALUATION. THE TECHNICAL EVALUATION OF ALL DEVICES CONCERNED WILL BE PERFORMED AS SOON AS THEY BECOME AVAILABLE. MEDICAL EVALUATION (PLEASE ALSO KINDLY REFER TO MFR REPORT 9680825-2017-00041 AND MFR REPORT 9680825-2017-00043). 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 ON THE EVENT ARE AVAILABLE. ORTHOFIX (B)(4) HAS REQUESTED ADDITIONAL DETAILS ON THE CASE, I.E. CODE AND LOT NUMBER OF THE DEVICES INVOLVED, WHETHER THEY WILL BE MADE AVAILABLE FOR THE TECHNICAL INVESTIGATION, TREATMENT PERFORMED, DETAILS ON THE ADDITIONAL SURGERY PERFORMED, COPY OF X-RAY IMAGES, PATIENT CURRENT HEALTH CONDITION. NO INFORMATION WAS RECEIVED SO FAR. AS SOON AS FURTHER INFORMATION ON THE CASE IS AVAILABLE, ORTHOFIX (B)(4) WILL PROVIDE YOU WITH A FOLLOW UP REPORT. ORTHOFIX (B)(4) CONTINUES MONITORING THE DEVICES ON THE MARKET. DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: DEVICE CODE: 2 BONE SCREWS AND 1 OLIVE WIRE, CODE AND LOT NUMBER UNKNOWN. HOSPITAL NAME: (B)(6); SURGEON NAME: (B)(6); DATE OF SURGERY: NOT PROVIDED; BODY PART TO WHICH DEVICE WAS APPLIED: NOT PROVIDED; SURGERY DESCRIPTION: CORRECTION; PATIENT INFORMATION: (B)(6) YEAR-OLD, MALE; PROBLEM OBSERVED DURING: NOT PROVIDED; TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM; EVENT DESCRIPTION: "FAILURE OF HALF PINS X 2 AND ONE OLIVE WIRE". THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT: UN-RETRIEVED DEVICE FRAGMENTS; THE INITIAL SURGERY WAS COMPLETED WITH THE DEVICE; THE EVENT DID NOT LEAD TO A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE SURGICAL PROCEDURE; AN ADDITIONAL SURGERY WAS REQUIRED FOLLOWING DEVICE FAILURE: TBC; A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS REQUIRED: (B)(6); COPIES OF THE OPERATIVE REPORTS ARE AVAILABLE (NOT PROVIDED); COPIES OF THE X-RAY IMAGES ARE AVAILABLE (NOT PROVIDED); PATIENT CURRENT HEALTH CONDITION: NOT PROVIDED. FURTHER INFORMATION RECEIVED WITH THE NOTIFICATION: THE BROKEN HALF PIN IS STILL IN THE PATIENT LEG. HE HAS ALSO HAD A WIRE BREAK AT THE OLIVE, SAME AS THE ABOVE PATIENT. MANUFACTURER REFERENCE NUMBER: (B)(4). DISTRIBUTOR REFERENCE NUMBER: (B)(4). PLEASE ALSO KINDLY REFER TO MFR REPORT 9680825-2017-00041 FOLLOW UP 1 AND MFR REPORT 9680825-2017-00043 FOLLOW UP 1.

    Description of Event or Problem · 1

    THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: DEVICE CODE: 2 BONE SCREWS AND 1 OLIVE WIRE, CODE AND LOT NUMBER UNKNOWN; HOSPITAL NAME: (B)(6); SURGEON NAME: (B)(6); DATE OF SURGERY: NOT PROVIDED; BODY PART TO WHICH DEVICE WAS APPLIED: NOT PROVIDED; SURGERY DESCRIPTION: CORRECTION; PATIENT INFORMATION: (B)(6)-YEAR-OLD, MALE; PROBLEM OBSERVED DURING: NOT PROVIDED; TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM; EVENT DESCRIPTION: "FAILURE OF HALF PINS X 2 AND ONE OLIVE WIRE". THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT: UN-RETRIEVED DEVICE FRAGMENTS. THE INITIAL SURGERY WAS COMPLETED WITH THE DEVICE. THE EVENT DID NOT LEAD TO A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE SURGICAL PROCEDURE. AN ADDITIONAL SURGERY WAS REQUIRED FOLLOWING DEVICE FAILURE: TBC. A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS REQUIRED: 4/17. COPIES OF THE OPERATIVE REPORTS ARE AVAILABLE (NOT PROVIDED). COPIES OF THE X-RAY IMAGES ARE AVAILABLE (NOT PROVIDED). PATIENT CURRENT HEALTH CONDITION: NOT PROVIDED. FURTHER INFORMATION RECEIVED WITH THE NOTIFICATION: THE BROKEN HALF PIN IS STILL IN THE PATIENT LEG. HE HAS ALSO HAD A WIRE BREAK AT THE OLIVE, SAME AS THE ABOVE PATIENT. (B)(4). PLEASE ALSO KINDLY REFER TO MFR REPORT 9680825-2017-00041 AND MFR REPORT 9680825-2017-00043.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425027 BONE SCREW BONE SCREW JDW ORTHOFIX SRL UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention