TL,WIRE, BAYONET, 1.8MM X 400MM
Report
- Report Number
- 9680825-2016-00023
- Event Type
- Malfunction
- Date Received
- March 30, 2016
- Date of Event
- February 26, 2016
- Report Date
- May 13, 2016
- Manufacturer
- ORTHOFIX SRL
- Product Code
- KTT
- PMA / PMN Number
- K141078
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
ANALYSIS OF HISTORICAL RECORDS (PLEASE ALSO KINDLY REFER TO MFR REPORTS 9680825-2016-00022, 9680825-2016-00024 AND 9680825-2016-00025). ORTHOFIX (B)(4) CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE DEVICE CODE 54-1216 LOT 24058412 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2015, WAS COMPRISED OF (B)(4) DEVICES. ALL OF THEM HAVE ALREADY BEEN DISTRIBUTED TO THE MARKET. ACCORDING TO ORTHOFIX (B)(4) HISTORICAL RECORDS, THIS IS THE FIRST COMPLAINT NOTIFIED FROM THIS SPECIFIC DEVICE LOT. ORTHOFIX (B)(4) CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE DEVICE CODE 54-1216 LOT 24058411 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2015, WAS COMPRISED OF (B)(4) DEVICES. ALL OF THEM HAVE ALREADY BEEN DISTRIBUTED TO THE MARKET. ACCORDING TO ORTHOFIX (B)(4) HISTORICAL RECORDS, THIS IS THE FIRST COMPLAINT NOTIFIED FROM THIS SPECIFIC DEVICE LOT. ORTHOFIX (B)(4) CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE DEVICE CODE 54-1216 LOT 01062623 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2014, WAS COMPRISED OF (B)(4) DEVICES. ALL OF THEM HAVE ALREADY BEEN DISTRIBUTED TO THE MARKET. ACCORDING TO ORTHOFIX (B)(4) HISTORICAL RECORDS, THIS IS THE FIRST COMPLAINT NOTIFIED FROM THIS SPECIFIC DEVICE LOT. TECHNICAL EVALUATION (PLEASE ALSO KINDLY REFER TO MFR REPORTS 9680825-2016-00022, 9680825-2016-00024 AND 9680825-2016-00025). THE RETURNED DEVICES, RECEIVED ON MARCH 7TH, 2016, WERE EXAMINED BY ORTHOFIX (B)(4) QUALITY ENGINEERING AREA. IN PARTICULAR IT WAS RECEIVED: 1 TL WIRE CODE 54-1216 LOT 01062623, 1 TL WIRE CODE 54-1216 LOT 24058411, 2 TL WIRES CODE 54-1216 LOT 24058412. ALL DEVICES WERE SUBJECTED TO VISUAL AND DIMENSIONAL CHECK. THE VISUAL CHECK EVIDENCED THAT THE WIRE LOT 01062623 HAD THE TIP BROKEN WHILE THE OTHER THREE WIRES (LOTS 24058411X1 AND 24058412X2) HAD THE TIPS DAMAGED. THE DIMENSIONAL CHECK, PERFORMED WHERE POSSIBLE, DID NOT EVIDENCE ANY ANOMALIES. ONE OF THE DEVICES INVOLVED, THE WORST CASE ONE WHICH IS THE DEVICE LOT 01062623, WAS THEN SENT TO AN EXTERNAL LABORATORY FOR CHEMICAL, MECHANICAL AND FAILURE ANALYSIS. THE RESULTS OF THE COMPLETE TECHNICAL INVESTIGATION, PERFORMED ON THE WIRE LOT 01062623, EVIDENCED THE DEVICE CONFORMITY TO DESIGN AND PRODUCT SPECIFICATION. THE FAILURE OCCURRED IS ATTRIBUTABLE TO A TORSIONAL OVERLOAD. THIS RESULT IS ALSO APPLICABLE TO THE OTHER WIRES INVOLVED IN THIS INCIDENT. MEDICAL EVALUATION (PLEASE ALSO KINDLY REFER TO MFR REPORTS 9680825-2016-00022, 9680825-2016-00024 AND 9680825-2016-00025). THE INFORMATION MADE AVAILABLE ON THE CASE TOGETHER WITH THE RESULTS OF THE TECHNICAL INVESTIGATION WERE SENT TO OUR MEDICAL EVALUATOR. PLEASE FIND BELOW AN EXTRACT OF THE MEDICAL EVALUATIONS PERFORMED. MARCH 8TH, 2016: "WE ARE SIMPLY TOLD THAT ONE WIRE TIP BROKE AND 3 OTHER WIRE TIPS WERE DAMAGED; WE KNOW NOTHING ABOUT THE CIRCUMSTANCES OF THE EVENTS. I HAVE ASKED FOR X-RAYS TO ALLOW US TO SEE THE DETAILS OF WIRE USAGE AND UNDERSTAND THE MECHANICS OF THE SITUATION. THE IMAGES OF THE WIRES SHOW THAT THE BROKEN WIRE HAS BEEN SUBJECTED TO A FAILURE IN TORSION OF THE TROCAR TIP; THE POINTS OF THE OTHER 3 WIRES HAVE BEEN DAMAGED, AND ONE GIVES THE APPEARANCE OF HAVING BEEN OVERHEATED. THIS IS A VERY UNUSUAL EPISODE AND IT IS DIFFICULT TO KNOW WHAT MIGHT HAVE HAPPENED. WE MUST WAIT TO OBTAIN MORE INFORMATION". MAY 10TH, 2016 WITH THE RESULTS OF THE TECHNICAL INVESTIGATION: "THE EXACT CAUSE OF THE WIRE FAILURES OCCURRED IN THIS INCIDENT ARE NOT CLEAR. THE TECHNICAL EVALUATION REPORT EXPLAINS IN GREAT DETAIL HOW THE QUALITY OF THE MATERIAL WAS CHECKED, TO BE SURE THAT THE PROPORTION OF CONSTITUENTS AND THE HARDNESS WERE WITHIN EXPECTED LIMITS, AND THIS WAS THE CASE. THESE ARE THE FIRST BREAKAGES ON MORE THAN (B)(4) SALES SINCE 2007. THEREFORE SOMETHING QUITE EXCEPTIONAL MUST HAVE HAPPENED TO THE WIRES OR TO THE BONE QUALITY TO CAUSE THESE PROBLEMS. IT IS CLEAR FROM THE IMAGES THAT THE TIPS OF THE AFFECTED WIRES HAVE BEEN DESTROYED BY THE PROCESS. THESE WIRES MUST HAVE BEEN TREATED TO A PHYSICAL LOAD WELL BEYOND THAT ENVISAGED BY THEIR SPECIFICATIONS. FACTORS THAT MIGHT PRODUCE THIS RESULT ARE INSERTION AT TOO HIGH A SPEED, OR ATTEMPTED PENETRATION OF VERY HARD CORTICAL BONE, OR PROBABLY A COMBINATION OF THE TWO". FINAL COMMENTS (PLEASE ALSO KINDLY REFER TO MFR REPORTS 9680825-2016-00022, 9680825-2016-00024 AND 9680825-2016-00025). THE RESULTS OF THE COMPLETE TECHNICAL INVESTIGATION, PERFORMED ON THE WIRE LOT 01062623, EVIDENCED THE DEVICE CONFORMITY TO DESIGN AND PRODUCT SPECIFICATION. THE FAILURE OCCURRED IS ATTRIBUTABLE TO A TORSIONAL OVERLOAD. THIS RESULT IS ALSO APPLICABLE TO THE OTHER WIRES INVOLVED IN THIS INCIDENT. THE MEDICAL EVALUATION EVIDENCED AS FOLLOW: "THE EXACT CAUSE OF THE WIRE FAILURES OCCURRED IN THIS INCIDENT ARE NOT CLEAR. THE TECHNICAL EVALUATION REPORT EXPLAINS IN GREAT DETAIL HOW THE QUALITY OF THE MATERIAL WAS CHECKED, TO BE SURE THAT THE PROPORTION OF CONSTITUENTS AND THE HARDNESS WERE WITHIN EXPECTED LIMITS, AND THIS WAS THE CASE. THESE ARE THE FIRST BREAKAGES ON MORE THAN (B)(4) SALES SINCE 2007. THEREFORE SOMETHING QUITE EXCEPTIONAL MUST HAVE HAPPENED TO THE WIRES OR TO THE BONE QUALITY TO CAUSE THESE PROBLEMS. IT IS CLEAR FROM THE IMAGES THAT THE TIPS OF THE AFFECTED WIRES HAVE BEEN DESTROYED BY THE PROCESS. THESE WIRES MUST HAVE BEEN TREATED TO A PHYSICAL LOAD WELL BEYOND THAT ENVISAGED BY THEIR SPECIFICATIONS. FACTORS THAT MIGHT PRODUCE THIS RESULT ARE INSERTION AT TOO HIGH A SPEED, OR ATTEMPTED PENETRATION OF VERY HARD CORTICAL BONE, OR PROBABLY A COMBINATION OF THE TWO". A COMPLETE MEDICAL EVALUATION OF THE CASE WAS NOT PERFORMED AS SOME INFORMATION ABOUT THE MEDICAL PROCEDURE WAS NOT MADE AVAILABLE, I.E. COPIES OF THE X-RAY IMAGES AND COPIES OF THE OPERATIVE REPORT. BASED ON THE RESULTS OF THE TECHNICAL INVESTIGATION AND ON THE EVIDENCES DERIVING FROM THE MEDICAL EVALUATION, ORTHOFIX (B)(4) CAN CONCLUDE THAT THE PROBLEM THAT OCCURRED IS NOT DEVICE-RELATED. ORTHOFIX (B)(4) HISTORICAL RECORDS SHOWS THAT NO OTHER NOTIFICATIONS HAVE BEEN RECEIVED IN REGARDS TO THESE SPECIFIC DEVICE LOTS. ORTHOFIX (B)(4) CONTINUES MONITORING THE DEVICES ON THE MARKET. PLEASE ALSO KINDLY REFER TO MFR REPORTS 9680825-2016-00022, 9680825-2016-00024 AND 9680825-2016-00025.
ANALYSIS OF HISTORICAL RECORDS: ORTHOFIX (B)(4) CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE DEVICE CODE 54-1216 LOT 24058412 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2015, WAS COMPRISED OF (B)(4) DEVICES. ALL OF THEM HAVE ALREADY BEEN DISTRIBUTED TO THE MARKET. ACCORDING TO ORTHOFIX (B)(4) HISTORICAL RECORDS, THIS IS THE FIRST COMPLAINT NOTIFIED FROM THIS SPECIFIC DEVICE LOT. TECHNICAL EVALUATION: 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 TECHNICAL EVALUATION WILL BE AVAILABLE. AS SOON AS THE RESULTS OF THE INVESTIGATION WILL BE AVAILABLE, ORTHOFIX (B)(4) WILL PROVIDE YOU WITH A FOLLOW UP REPORT. ORTHOFIX (B)(4) CONTINUES MONITORING THE DEVICES ON THE MARKET. PLEASE ALSO KINDLY REFER TO MFR REPORTS 9680825-2016-00022, 9680825-2016-00024 AND 9680825-2016-00025. DEVICE EVALUATION CURRENTLY ON GOING.
THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: PRODUCT CODE: 54-1216 (TL,WIRE, BAYONET, 1.8MM X 400MM), BATCH NUMBER: 24058412 (X2), 24058411 (X1), 01062623 (X1); PLEASE ALSO KINDLY REFER TO MFR REPORTS 9680825-2016-00022, 9680825-2016-00024 AND 9680825-2016-00025. QUANTITY: 4. HOSPITAL NAME: (B)(6). SURGEON'S NAME: MR (B)(6). DATE OF SURGERY: FRIDAY (B)(6) 2016. BODY PART TO WHICH DEVICE WAS APPLIED: TIBIA. SURGERY DESCRIPTION: FRACTURE TREATMENT. PATIENT INFORMATION: MALE, MID AGE, MID WEIGHT. PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: A LIKE THE PREVIOUS EVENT AT (B)(6) 2 WEEKS AGO THE WIRE WAS BEING INSERTED INTO THE BONE AND THE TIP SNAPPED OFF, REMAINING IN THE PATIENT, TOO CLOSE TO THE FRACTURE SIGHT TO BE REMOVED WITH A CANNULATED DRILL.. THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT (UN-RETRIEVED DEVICE FRAGMENTS). THE SURGERY WAS NOT COMPLETED WITH USED DEVICE. A REPLACEMENT DEVICE WAS IMMEDIATELY AVAILABLE TO COMPLETE THE SURGERY. THE EVENT DID NOT LEAD TO A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE SURGICAL PROCEDURE. AN ADDITIONAL SURGERY WAS NOT REQUIRED (NOT AWARE OF ANY CURRENTLY). COPIES OF THE OPERATIVE REPORTS ARE NOT AVAILABLE. COPIES OF THE X-RAY IMAGES ARE NOT AVAILABLE. PATIENT CURRENT HEALTH CONDITION: NOT AVAILABLE. NOTE AND COMMENTS: IF MORE INFORMATION IS REQUIRED FROM THE SURGEON I AM SURE HE WILL BE HAPPY TO PROVIDE AS MUCH DETAIL AS REQUIRED. ON MARCH 18, 2016, ORTHOFIX (B)(4) RECEIVED THE FOLLOWING INFORMATION FROM THE LOCAL DISTRIBUTOR: "UNFORTUNATELY, WE COULDN'T GET FURTHER DETAILS REGARDING YOUR REQUEST (COPIES OF THE X-RAY IMAGES, COPIES OF THE OPERATIVE REPORT AND INFORMATION ABOUT PATIENT CURRENT HEALTH CONDITION). MR (B)(4) (CONSULTANT), SAID HE IS CONCERNED AS HE WILL HAVE TO GET THE PATIENT'S CONSENT FOR THIS. THE PATIENT ALSO DIDN'T SHOW UP TO HIS APPOINTMENT IN CLINIC SO THEREFORE HASN'T SEEN HIM SINCE THE OPERATION AND WOULD NEED TO SEE HIM TO GET CONSENT. " PLEASE ALSO KINDLY REFER TO MFR REPORTS 9680825-2016-00022, 9680825-2016-00024 AND 9680825-2016-00025. (B)(4).
THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: PRODUCT CODE: 54-1216 (TL,WIRE, BAYONET, 1.8MM X 400MM). BATCH NUMBER: 24058412 (X2), 24058411 (X1), 01062623 (X1); PLEASE ALSO KINDLY REFER TO MFR REPORTS 9680825-2016-00022, 9680825-2016-00024 AND 9680825-2016-00025. QUANTITY: 4. HOSPITAL NAME: (B)(6). SURGEON'S NAME: MR (B)(6). DATE OF SURGERY: FRIDAY (B)(6) 2016. BODY PART TO WHICH DEVICE WAS APPLIED: TIBIA. SURGERY DESCRIPTION: FRACTURE TREATMENT. PATIENT INFORMATION: MALE, MID AGE, MID WEIGHT. PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: A LIKE THE PREVIOUS EVENT AT (B)(6) 2 WEEKS AGO THE WIRE WAS BEING INSERTED INTO THE BONE AND THE TIP SNAPPED OFF, REMAINING IN THE PATIENT, TOO CLOSE TO THE FRACTURE SIGHT TO BE REMOVED WITH A CANNULATED DRILL. THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT (UN-RETRIEVED DEVICE FRAGMENTS). THE SURGERY WAS NOT COMPLETED WITH USED DEVICE. A REPLACEMENT DEVICE WAS IMMEDIATELY AVAILABLE TO COMPLETE THE SURGERY. THE EVENT DID NOT LEAD TO A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE SURGICAL PROCEDURE. AN ADDITIONAL SURGERY WAS NOT REQUIRED (NOT AWARE OF ANY CURRENTLY). COPIES OF THE OPERATIVE REPORTS ARE NOT AVAILABLE. COPIES OF THE X-RAY IMAGES ARE NOT AVAILABLE. PATIENT CURRENT HEALTH CONDITION: NOT AVAILABLE. NOTE AND COMMENTS: IF MORE INFORMATION IS REQUIRED FROM THE SURGEON I AM SURE HE WILL BE HAPPY TO PROVIDE AS MUCH DETAIL AS REQUIRED. ON MARCH 18, 2016, ORTHOFIX (B)(4) RECEIVED THE FOLLOWING INFORMATION FROM THE LOCAL DISTRIBUTOR: "UNFORTUNATELY, WE COULDN'T GET FURTHER DETAILS REGARDING YOUR REQUEST (COPIES OF THE X-RAY IMAGES, COPIES OF THE OPERATIVE REPORT AND INFORMATION ABOUT PATIENT CURRENT HEALTH CONDITION). MR (B)(6) (CONSULTANT), SAID HE IS CONCERNED AS HE WILL HAVE TO GET THE PATIENT'S CONSENT FOR THIS. THE PATIENT ALSO DIDN'T NOT SHOW UP TO HIS APPOINTMENT IN CLINIC SO THEREFORE HASN'T SEEN HIM SINCE THE OPERATION AND WOULD NEED TO SEE HIM TO GET CONSENT. " PLEASE ALSO KINDLY REFER TO MFR REPORTS 9680825-2016-00022, 9680825-2016-00024 AND 9680825-2016-00025. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 191624 | TL,WIRE, BAYONET, 1.8MM X 400MM | TL,WIRE, BAYONET, 1.8MM X 400MM | KTT | ORTHOFIX SRL | 54-1216 | 24058412 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |