OLIVE WIRE
Report
- Report Number
- 9680825-2017-00040
- Event Type
- Injury
- Date Received
- June 8, 2017
- Report Date
- July 27, 2017
- Manufacturer
- ORTHOFIX SRL
- Product Code
- KTT
- PMA / PMN Number
- K170650
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
ANALYSIS OF HISTORICAL RECORDS (PLEASE ALSO KINDLY REFER TO MFR REPORT 9680825-2017-00039) ORTHOFIX SRL CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE OSTEOTITE BONE SCREW CODE 99-60138 LOT V1413445 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2015, WAS COMPRISED OF 100 DEVICES. ALL OF THEM HAVE ALREADY BEEN DISTRIBUTED TO THE MARKET. ACCORDING TO ORTHOFIX SRL HISTORICAL RECORDS, THIS IS THE FIRST COMPLAINT NOTIFIED FROM THIS SPECIFIC DEVICE LOT. NO INFORMATION HAS BEEN PROVIDED REGARDING THE CODE REFERENCE AND LOT NUMBER OF THE 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 9680825-2017-00039). THE RETURNED OSTEOTITE BONE SCREW RECEIVED ON MAY 17, 2017 WAS EXAMINED BY ORTHOFIX SRL QUALITY ENGINEERING AREA. THE DEVICE WAS SUBJECTED TO VISUAL CHECK AS PER ORTHOFIX SRL SPECIFICATION. THE VISUAL CHECK CONFIRMED THE PROBLEM NOTIFIED, THE SCREW IS BROKEN IN TWO PIECES. THE SURFACE OF THE BROKEN THREAD REVEALS THAT THE FAILURE IS TYPICAL OF A BREAKAGE OCCURRED BECAUSE OF AN EXCESSIVE BENDING. THE DIMENSIONAL CHECK WAS NOT PERFORMED AS THE DEVICE IS DAMAGED AND DEFORMED. A FUNCTIONAL CHECK ON THE RETURNED DEVICE WAS NOT POSSIBLE AS THE DEVICE IS BROKEN AND THEREFORE NOT FUNCTIONING. THE DEVICE WAS THEN SENT TO AN EXTERNAL LABORATORY FOR THE RAW MATERIAL CHECK AND THE FAILURE ANALYSIS. FROM THE RESULTS OF THE TECHNICAL EVALUATION, IT WAS CONFIRMED THE DEVICE CONFORMITY TO DESIGN SPECIFICATION. THE OSTEOTITE BONE SCREW FAILED DUE TO EXCESSIVE LOAD (PATIENT CATCHING HER FRAME ON HER BED). THE OLIVE WIRE CONCERNED HAS NOT BEEN RETURNED YET. AS SOON AS THE DEVICE IS AVAILABLE, IT WILL BE PERFORMED THE TECHNICAL EVALUATION. MEDICAL EVALUATION (PLEASE ALSO KINDLY REFER TO MFR REPORT 9680825-2017-00039). 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 COMPLETE TECHNICAL INVESTIGATION RESULTS ARE MADE AVAILABLE. ORTHOFIX SRL HAS REQUESTED ADDITIONAL DETAILS ON THE CASE, I.E. CODE AND LOT NUMBER OF THE OLIVE WIRE INVOLVED, WHETHER THE OLIVE WIRE WILL BE MADE AVAILABLE FOR THE TECHNICAL INVESTIGATION, PATIENT'S HEIGHT AND WEIGHT, TREATMENT PERFORMED AFTER THE FAILURE OF THE TWO DEVICES, FRAME CONFIGURATION APPLIED, COPY OF X-RAY IMAGES. NO INFORMATION WAS RECEIVED SO FAR. AS SOON AS FURTHER INFORMATION ON THE CASE IS AVAILABLE, ORTHOFIX SRL WILL PROVIDE YOU WITH A FOLLOW UP REPORT. ORTHOFIX SRL CONTINUES MONITORING THE DEVICES ON THE MARKET.
ANALYSIS OF HISTORICAL RECORDS: ORTHOFIX SRL CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE OSTEOTITE BONE SCREW CODE 99-60138 LOT V1413445 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2015, WAS COMPRISED OF 100 DEVICES. ALL OF THEM HAVE ALREADY BEEN DISTRIBUTED TO THE MARKET. ACCORDING TO ORTHOFIX SRL HISTORICAL RECORDS, THIS IS THE FIRST COMPLAINT NOTIFIED FROM THIS SPECIFIC DEVICE LOT. NO INFORMATION HAS BEEN PROVIDED REGARDING THE CODE REFERENCE AND LOT NUMBER OF THE OLIVE WIRE INVOLVED IN THIS EVENT, THEREFORE IT WAS NOT POSSIBLE TO PERFORM THE VERIFICATION OF THE HISTORICAL DATA. TECHNICAL EVALUATION: THE RETURNED OSTEOTITE BONE SCREW RECEIVED ON MAY 17, 2017 WAS EXAMINED BY ORTHOFIX SRL QUALITY ENGINEERING AREA. THE DEVICE WAS SUBJECTED TO VISUAL CHECK AS PER ORTHOFIX SRL SPECIFICATION. THE VISUAL CHECK CONFIRMED THE PROBLEM NOTIFIED, THE SCREW IS BROKEN IN TWO PIECES. THE SURFACE OF THE BROKEN THREAD REVEALS THAT THE FAILURE IS TYPICAL OF A BREAKAGE OCCURRED BECAUSE OF AN EXCESSIVE BENDING. THE DIMENSIONAL CHECK WAS NOT PERFORMED AS THE DEVICE IS DAMAGED AND DEFORMED. A FUNCTIONAL CHECK ON THE RETURNED DEVICE WAS NOT POSSIBLE AS THE DEVICE IS BROKEN AND THEREFORE NOT FUNCTIONING. THE DEVICE WAS THEN SENT TO AN EXTERNAL LABORATORY FOR THE RAW MATERIAL CHECK AND THE FAILURE ANALYSIS. FROM THE RESULTS OF THE TECHNICAL EVALUATION, IT WAS CONFIRMED THE DEVICE CONFORMITY TO DESIGN SPECIFICATION. THE OSTEOTITE BONE SCREW FAILED DUE TO EXCESSIVE LOAD (PATIENT CATCHING HER FRAME ON HER BED). AS THE OLIVE WIRE CONCERNED WAS NOT RETURNED IT WAS NOT POSSIBLE TO PERFORM THE TECHNICAL EVALUATION. MEDICAL EVALUATION: THE INFORMATION MADE AVAILABLE ON THE CASE WAS SENT TO OUR MEDICAL EVALUATOR. PLEASE FIND BELOW AN EXTRACT OF THE MEDICAL EVALUATION PERFORMED: "A (B)(6) YEAR OLD GIRL WAS HAVING LENGTHENING TO A LONG BONE (NOT SPECIFIED), AND AN OLIVE WIRE AND A 3.5 - 4.5 MM THREADED OSTEOTITE SCREW BROKE AFTER THE PATIENT CAUGHT THE FRAME ON HER BED. PATIENTS OF THIS AGE CAN VERY FROM SMALL CHILD TO NEAR ADULT IN SIZE, AND ARE USUALLY QUITE ACTIVE; IT IS IMPOSSIBLE FOR US TO JUDGE THE MECHANICS OF THE FRAME, AS WE DO NOT KNOW WHICH BONE WAS BEING TREATED AND WHAT THE FRAME CONFIGURATION WAS. I AM SURE THAT A SINGLE SCREW OF THIS SIZE IS VERY VULNERABLE TO ACUTE BREAKAGE IN A LARGER PAEDIATRIC PATIENT. BECAUSE OF THE LACK OF BASIC INFORMATION WE CANNOT REALLY MAKE ANY SENSIBLE COMMENT ABOUT THE REASON FOR THIS BREAKAGE. WE NEED TO KNOW THE HEIGHT AND WEIGHT OF THE PATIENT AND THE DETAILED FRAME CONFIGURATION. IT IS CLEAR FROM THE TECHNICAL ANALYSIS THAT THE SCREW FAILED BECAUSE OF EXCESSIVE LOAD, WHICH WOULD FIT WITH THE HISTORY OF A BLOW TO THE FRAME. WE KNOW NOTHING ABOUT THE OLIVE WIRE." FINAL COMMENTS: THE RESULTS OF THE TECHNICAL EVALUATION EVIDENCED THAT THE DEVICE RETURNED WAS CONFORMING TO DESIGN SPECIFICATION. THE OSTEOTITE BONE SCREW FAILED DUE TO EXCESSIVE LOAD (PATIENT CATCHING HER FRAME ON HER BED). AS THE OLIVE WIRE CONCERNED WAS NOT RETURNED IT WAS NOT POSSIBLE TO PERFORM THE TECHNICAL EVALUATION. A COMPLETE MEDICAL EVALUATION WAS NOT POSSIBLE AS SOME INFORMATION AS PATIENT'S HEIGHT AND WEIGHT, TREATMENT PERFORMED AFTER THE FAILURE OF THE TWO DEVICES, FRAME CONFIGURATION APPLIED, COPY OF X-RAY IMAGES, WAS NOT MADE AVAILABLE. ORTHOFIX SRL HAS REQUESTED ADDITIONAL DETAILS ON THE CASE, I.E. CODE AND LOT NUMBER OF THE OLIVE WIRE INVOLVED, WHETHER THE OLIVE WIRE WILL BE MADE AVAILABLE FOR THE TECHNICAL INVESTIGATION, PATIENT'S HEIGHT AND WEIGHT, TREATMENT PERFORMED AFTER THE FAILURE OF THE TWO DEVICES, FRAME CONFIGURATION APPLIED, COPY OF X-RAY IMAGES. NO FURTHER INFORMATION WAS RECEIVED. BASED ON THE RESULTS OF THE TECHNICAL EVALUATION PERFORMED ON THE RETURNED DEVICE (OSTEOTITE BONE SCREW), ORTHOFIX SRL CAN CONCLUDE THAT THE PROBLEM OCCURRED COULD BE MAINLY ATTRIBUTABLE TO THE CONDITIONS OF USE OF THE DEVICES (EXCESSIVE LOAD APPLIED). ORTHOFIX SRL CONTINUES MONITORING THE DEVICES ON THE MARKET. (PLEASE ALSO KINDLY REFER TO MFR REPORT 9680825-2017-00039 FOLLOW UP 1).
THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: -HOSPITAL NAME: (B)(6). -SURGEON'S NAME: (B)(6). -DATE OF INITIAL SURGERY: TO BE SUPPLIED -BODY PART TO WHICH DEVICE WAS APPLIED: NOT AVAILABLE -SURGERY DESCRIPTION: LENGTHENING -PATIENT'S INFORMATION: (B)(6), FEMALE -PROBLEM OBSERVED DURING: INTO TREATMENT/POST-OPERATIVE -TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM -EVENT DESCRIPTION: "(B)(6) FROM (B)(6) HAS INFORMED ME THAT THERE HAS BEEN ONE HALF PIN AND ONE WIRE BREAKAGE WITH ONE OF HIS FEMALE PAEDIATRIC TLHEX FRAMES. THE PATIENT IS BEING TAKEN BACK TO THEATRE THIS FRIDAY ((B)(6)) TO HAVE THE BROKEN HALF PINS AND WIRES REPLACED WHICH I HAD SENT OUT FROM THE OFFICE YESTERDAY. THE CHILD IS OK ALTHOUGH HER REGENERATE IS DRIFTING A LITTLE INTO A NEW VALGUS DEFORMITY. FROM WHAT THE SURGEON HAS TOLD ME, THE DAMAGE HAS BEEN CAUSED BY THE PATIENT CATCHING HER FRAME ON HER BED." THE COMPLAINT REPORT FORM ALSO INDICATES: -THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT: LOSS OF DISTRACTION/CORRECTION ACHIEVED. -THE INITIAL SURGERY WAS COMPLETED WITH THE DEVICE. -AN ADDITIONAL SURGERY WAS REQUIRED FOLLOWING DEVICE FAILURE: 28 APRIL 2017. -A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS REQUIRED: 8 MAY 2017. -COPY OF OPERATIVE REPORTS IS AVAILABLE (NOT PROVIDED). -COPY OF X-RAY IMAGES IS AVAILABLE (NOT PROVIDED). -INFORMATION ON PATIENT CURRENT HEALTH CONDITION: NO PROBLEMS. ON (B)(6) 2017, ORTHOFIX SRL RECEIVED THE FOLLOWING ADDITIONAL INFORMATION ON THE EVENT: "(B)(6) HAS TRIED TO PUT 6 LONG TLHEX STRUTS ON AS THE WIRE/PIN BREAKAGE HAS CAUSED THE PATIENT TO GO INTO A NEW VALGUS DEFORMITY (SHE CURRENTLY HAS TELESCOPIC LINEAR DISTRACTORS ON). THIS ATTEMPT HAS BEEN UNSUCCESSFUL DUE TO RINGS BEING TOO FAR APART. (B)(6) IS GOING TO PUT HER UNDER ANAESTHETIC ON MONDAY ((B)(6) 2017) WITH THE INTENTION OF ADDING ON A SLAVE RING (5/8TH TLHEX RING) WITH TLHEX STANDOFF TABS TO CREATE A RING BLOCK AS WELL AS DOING A FORM OF ACUTE CORRECTION TO STRAIGHTEN HER LEG. THIS WILL BE THE SECOND PROCEDURE EXCLUDING THE INITIAL SURGERY." ON (B)(6) 2017, ORTHOFIX SRL RECEIVED THE FOLLOWING ADDITIONAL INFORMATION ON THE EVENT: · THE TLHEX WAS APPLIED TO THE TIBIA. · DATE OF INITIAL OPERATION TO BE SUPPLIED BY (B)(6) WE WILL FOLLOW UP WITH HIM AND WE ALSO DO NOT HAVE THE LOT NUMBER BUT TRY TO LINK THIS BACK TO THE LOAN KIT DATE/CASE INFO. · (B)(6) ADVISES "THE PIN AND WIRE SNAPPED, 2 MONTHS AFTER LENGTHENING". · THE PATIENT WAS REOPERATED ON (B)(6) BUT THE STRUTS WERE NOT APPLIED AT THIS STAGE. THE STRUTS WERE TRIED DURING A SUBSEQUENT CLINIC VISIT. · PATIENTS CURRENT HEALTH IS FINE. (B)(4). PLEASE ALSO KINDLY REFER TO MFR REPORT 9680825-2017-00039.
THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6). SURGEON'S NAME: (B)(6). DATE OF INITIAL SURGERY: TO BE SUPPLIED. BODY PART TO WHICH DEVICE WAS APPLIED: NOT AVAILABLE. SURGERY DESCRIPTION: LENGTHENING. PATIENT'S INFORMATION: (B)(6) YEARS OLD, FEMALE. PROBLEM OBSERVED DURING: INTO TREATMENT/POST-OPERATIVE. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: "(B)(6) FROM UNIVERSITY HOSPITAL NORTH DURHAM HAS INFORMED ME THAT THERE HAS BEEN ONE HALF PIN AND ONE WIRE BREAKAGE WITH ONE OF HIS FEMALE PAEDIATRIC TLHEX FRAMES. THE PATIENT IS BEING TAKEN BACK TO THEATRE THIS FRIDAY (B)(6) TO HAVE THE BROKEN HALF PINS AND WIRES REPLACED WHICH I HAD SENT OUT FROM THE OFFICE YESTERDAY. THE CHILD IS OK ALTHOUGH HER REGENERATE IS DRIFTING A LITTLE INTO A NEW VALGUS DEFORMITY. FROM WHAT THE SURGEON HAS TOLD ME, THE DAMAGE HAS BEEN CAUSED BY THE PATIENT CATCHING HER FRAME ON HER BED." THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT: LOSS OF DISTRACTION/CORRECTION ACHIEVED. THE INITIAL SURGERY WAS COMPLETED WITH THE DEVICE. AN ADDITIONAL SURGERY WAS REQUIRED FOLLOWING DEVICE FAILURE: (B)(6) 2017. A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS REQUIRED: (B)(6) 2017. COPY OF OPERATIVE REPORTS IS AVAILABLE (NOT PROVIDED). COPY OF X-RAY IMAGES IS AVAILABLE (NOT PROVIDED). INFORMATION ON PATIENT CURRENT HEALTH CONDITION: NO PROBLEMS. ON MAY 11, 2017, ORTHOFIX SRL RECEIVED THE FOLLOWING ADDITIONAL INFORMATION ON THE EVENT: "(B)(6) HAS TRIED TO PUT 6 LONG TLHEX STRUTS ON AS THE WIRE/PIN BREAKAGE HAS CAUSED THE PATIENT TO GO INTO A NEW VALGUS DEFORMITY (SHE CURRENTLY HAS TELESCOPIC LINEAR DISTRACTORS ON). THIS ATTEMPT HAS BEEN UNSUCCESSFUL DUE TO RINGS BEING TOO FAR APART. (B)(6) IS GOING TO PUT HER UNDER ANAESTHETIC ON MONDAY ((B)(6) 2017) WITH THE INTENTION OF ADDING ON A SLAVE RING (5/8TH TLHEX RING) WITH TLHEX STANDOFF TABS TO CREATE A RING BLOCK AS WELL AS DOING A FORM OF ACUTE CORRECTION TO STRAIGHTEN HER LEG. THIS WILL BE THE SECOND PROCEDURE EXCLUDING THE INITIAL SURGERY." ON MAY 23, 2017, ORTHOFIX SRL RECEIVED THE FOLLOWING ADDITIONAL INFORMATION ON THE EVENT: THE TLHEX WAS APPLIED TO THE TIBIA. DATE OF INITIAL OPERATION TO BE SUPPLIED BY MR PAGE. WE WILL FOLLOW UP WITH HIM AND WE ALSO DO NOT HAVE THE LOT NUMBER BUT TRY TO LINK THIS BACK TO THE LOAN KIT DATE/CASE INFO. (B)(6) ADVISES "THE PIN AND WIRE SNAPPED, 2 MONTHS AFTER LENGTHENING". THE PATIENT WAS REOPERATED ON (B)(6) BUT THE STRUTS WERE NOT APPLIED AT THIS STAGE. THE STRUTS WERE TRIED DURING A SUBSEQUENT CLINIC VISIT. PATIENTS CURRENT HEALTH IS FINE. MANUFACTURER REFERENCE NUMBER: (B)(4). DISTRIBUTOR REFERENCE NUMBER: (B)(4). PLEASE ALSO KINDLY REFER TO MFR REPORT 9680825-2017-00039 FOLLOW UP 1.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 406847 | OLIVE WIRE | OLIVE WIRE | KTT | ORTHOFIX SRL | UNKNOWN | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 13 YR | Required Intervention |