TRUE LOK PLUS SHORT QUICK ADJUST STRUT
Report
- Report Number
- 9680825-2016-00093
- Event Type
- Injury
- Date Received
- October 21, 2016
- Date of Event
- September 29, 2016
- Report Date
- December 19, 2016
- Manufacturer
- ORTHOFIX SRL
- Product Code
- KTT
- PMA / PMN Number
- K152171
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
ANALYSIS OF HISTORICAL RECORDS ORTHOFIX (B)(4) CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE DEVICE CODE 50-10170 LOT V1407236 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 RETURNED DEVICE, RECEIVED ON NOVEMBER 4, 2016, WAS EXAMINED BY ORTHOFIX (B)(4) QUALITY ENGINEERING AREA. THE DEVICE WAS SUBJECTED TO VISUAL, DIMENSIONAL AND FUNCTIONAL CHECK AS PER ORTHOFIX (B)(4) SPECIFICATION. THE VISUAL CHECK CONFIRMED THE PROBLEM NOTIFIED, ONE THREADED ROD IS BROKEN DUE TO BENDING/FLEXIONAL OVERLOAD. ALSO THE PLASTIC DICE IS DAMAGED. THE THREADED ROD WAS CHECKED USING THE GO GAUGE AND THE PROJECTOR PROFILE AND FOUND TO BE IN CONFORMITY WITH THE SPECIFICATION. THE DIMENSIONAL CHECK EVIDENCED THAT THE DEVICE WAS ORIGINALLY CONFORMING TO SPECIFICATION. THE FUNCTIONAL CHECK, PERFORMED WHERE POSSIBLE AS THE DEVICE IS BROKEN, EVIDENCED THAT THE DEVICE IS FUNCTIONING PROPERLY EXCEPT FROM THE BROKEN PART. THE RESULTS OF THE TECHNICAL EVALUATION CONCLUDED THAT THE DEVICE WAS ORIGINALLY CONFORMING TO SPECIFICATION. THE FAILURE OCCURRED COULD BE MAINLY ATTRIBUTABLE TO THE APPLICATION OF EXCESSIVE FLEXIONAL LOAD. MEDICAL EVALUATION: THE INFORMATION MADE AVAILABLE ON THE EVENT TOGETHER WITH THE RESULTS OF THE TECHNICAL EVALUATION WERE SENT TO OUR MEDICAL EVALUATOR. PLEASE FIND BELOW AN EXTRACT OF THE MEDICAL EVALUATIONS PERFORMED. "I NOTE THAT IN THIS CASE THE PATIENT SUSTAINED A FALL DURING TREATMENT, WHICH RESULTED IN BREAKAGE OF ONE STRUT AS DESCRIBED. IT SEEMS MOST LIKELY THAT THE THREADED ROD OF THIS STRUT WAS OVER-LOADED DURING THE FALL. APPARENTLY IT WAS REPLACED AND THE FRACTURE REDUCED, WHICH IMPLIES THAT THE BONE POSITION WAS ALTERED BY THE FALL, AND CORRECTED IN A SECOND PROCEDURE OF SOME SORT. THE TECHNICAL ANALYSIS CONFIRMS THAT THE THREADED ROD CONCERNED WAS WITHIN SPECIFICATION AND THAT IT BROKE BECAUSE OF EXCESSIVE LOAD. THIS SUPPORTS OUR PREVIOUS CONCLUSION THAT IT BROKE WHEN THE PATIENT FELL, CAUSING A LOAD TO THE STRUT BEYOND ITS DESIGN CRITERIA". FINAL COMMENTS: THE RESULTS OF THE TECHNICAL EVALUATION CONCLUDED THAT THE DEVICE WAS ORIGINALLY CONFORMING TO SPECIFICATION. THE FAILURE OCCURRED COULD BE MAINLY ATTRIBUTABLE TO THE APPLICATION OF EXCESSIVE FLEXIONAL LOAD. THE MEDICAL EVALUATION EVIDENCED AS FOLLOWS: "I NOTE THAT IN THIS CASE THE PATIENT SUSTAINED A FALL DURING TREATMENT, WHICH RESULTED IN BREAKAGE OF ONE STRUT AS DESCRIBED. IT SEEMS MOST LIKELY THAT THE THREADED ROD OF THIS STRUT WAS OVER-LOADED DURING THE FALL. APPARENTLY IT WAS REPLACED AND THE FRACTURE REDUCED, WHICH IMPLIES THAT THE BONE POSITION WAS ALTERED BY THE FALL, AND CORRECTED IN A SECOND PROCEDURE OF SOME SORT. THE TECHNICAL ANALYSIS CONFIRMS THAT THE THREADED ROD CONCERNED WAS WITHIN SPECIFICATION AND THAT IT BROKE BECAUSE OF EXCESSIVE LOAD. THIS SUPPORTS OUR PREVIOUS CONCLUSION THAT IT BROKE WHEN THE PATIENT FELL, CAUSING A LOAD TO THE STRUT BEYOND ITS DESIGN CRITERIA". 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. 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 MAINLY DUE TO THE OVERLOAD APPLIED WHEN THE PATIENT FELL. ORTHOFIX (B)(4) HISTORICAL RECORDS SHOWS THAT NO OTHER NOTIFICATIONS HAVE BEEN RECEIVED IN REGARDS TO THIS SPECIFIC DEVICE LOT. ORTHOFIX (B)(4) CONTINUES MONITORING THE DEVICES ON THE MARKET.
ANALYSIS OF HISTORICAL RECORDS: THE DEVICE INVOLVED IN THIS EVENT HAS NOT YET BEEN RECEIVED BY ORTHOFIX (B)(4). UNFORTUNATELY ALSO THE CODE AND LOT NUMBER HAS NOT BEEN MADE AVAILABLE AND THEREFORE IT WAS NOT POSSIBLE TO PERFORM THE VERIFICATION OF THE HISTORICAL DATA. TECHNICAL EVALUATION: A TECHNICAL EVALUATION OF THE DEVICE INVOLVED WAS NOT POSSIBLE AS THE DEVICE HAS NOT YET BEEN RECEIVED. THE TECHNICAL EVALUATION WILL BE PERFORMED AS SOON AS THE DEVICE BECOMES AVAILABLE. MEDICAL EVALUATION: THE LITTLE INFORMATION MADE AVAILABLE ON THE CASE WAS SENT TO OUR MEDICAL EVALUATOR. THE MEDICAL EVALUATION IS CURRENTLY ON GOING AND WILL BE CLOSED ONCE FURTHER INFORMATION ON THE CASE WILL BE AVAILABLE. ORTHOFIX (B)(4) HAS REQUESTED FURTHER INFORMATION ON THE EVENT, SUCH AS THE COMPLETED COMPLAINT REPORT FORM. UNFORTUNATELY THIS INFORMATION HAS NOT YET BEEN MADE 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. DEVICE NOT YET MADE AVAILABLE.
ANALYSIS OF HISTORICAL RECORDS ORTHOFIX (B)(4) CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE DEVICE CODE 50-10170, LOT V1407236 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2015, WAS COMPRISED OF 7 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 DEVICE, RECEIVED ON NOVEMBER 4, 2016, 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.
THE INFORMATION PROVIDED BY THE SURGEON INDICATES: "I'VE GOT A BROKEN TRAUMA STRUT NOW" ON OCTOBER 27, 2016, ORTHOFIX (B)(4) RECEIVED THE COMPLAINT REPORT FORM WHICH INCLUDED THE FOLLOWING INFORMATION: PRODUCT CODE: 50-10170; BATCH NUMBER: (B)(4); QUANTITY: 1; HOSPITAL NAME: (B)(6) HOSPITAL; SURGEON NAME: MR (B)(6); DATE OF INITIAL SURGERY: NOT PROVIDED; BODY PART TO WHICH DEVICE WAS APPLIED: NOT PROVIDED; SURGERY DESCRIPTION: FRACTURE TREATMENT; PATIENT INFORMATION: MALE, (B)(6); PROBLEM OBSERVED DURING: INTO TREATMENT/POST-OPERATIVE; TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM; EVENT DESCRIPTION: PATIENT HAD A THREE RING CONSTRUCT WITH 2 X RAPID STRUTS SPANNING THE BETWEEN THE FOOTPLATE AND THE DISTAL RING. FOLLOWING A FALL, ONE OF THESE RAPID STRUTS BROKE. THE THREADED ROD FATIGUED MIDWAY DOWN INSIDE THE PLASTIC DICE PORTION. THE ONE STRUT WAS THEN REPLACED WITH TWO OTHERS AND THE FRACTURE REDUCED. THE COMPLAINT REPORT FORM ALSO INDICATED: - THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT (LOSS OF FRACTURE REDUCTION) - THE INITIAL SURGERY WAS COMPLETED WITH DEVICE - THE EVENT DID NOT LEAD TO A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE SURGICAL PROCEDURE - AN ADDITIONAL SURGERY WAS NOT REQUIRED FOLLOWING DEVICE FAILURE - A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS REQUIRED FOLLOWING DEVICE FAILURE - COPIES OF THE OPERATIVE REPORTS ARE NOT AVAILABLE - COPIES OF THE X-RAYS IMAGES ARE AVAILABLE (NOT RECEIVED) - PATIENT CURRENT HEALTH CONDITION: NOT PROVIDED. ON NOVEMBER 23, 2016 ORTHOFIX (B)(4) RECEIVED THE FOLLOWING ADDITIONAL INFORMATION FROM THE TERRITORY MANAGER: "I'VE SPOKEN TO BOTH MR (B)(4) THE REGISTRAR. THEY ARE UNABLE TO REMEMBER OR FIND THE PATIENT ON THE SYSTEM. HE HAS DONE A NUMBER OF FRAMES SINCE. SO I DO NOT THINK I WILL BE ABLE TO GET THIS INFORMATION NOW UNTIL THE PATIENT NEXT TURNS UP IN CLINIC". (B)(4).
THE INFORMATION PROVIDED BY THE SURGEON INDICATES: "I'VE GOT A BROKEN TRAUMA STRUT NOW". (B)(4).
THE INFORMATION PROVIDED BY THE SURGEON INDICATES: "I'VE GOT A BROKEN TRAUMA STRUT NOW." ON OCTOBER 27, 2016, ORTHOFIX (B)(4) RECEIVED THE COMPLAINT REPORT FORM WHICH INCLUDED THE FOLLOWING INFORMATION: PRODUCT CODE: 50-10170. BATCH NUMBER: V1407236. QUANTITY: 1. HOSPITAL NAME: (B)(6) HOSPITAL. SURGEON NAME: (B)(6). SURGERY DESCRIPTION: FRACTURE TREATMENT. PATIENT INFORMATION: MALE, (B)(6). PROBLEM OBSERVED DURING: INTO TREATMENT/POST-OPERATIVE. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: PATIENT HAD A THREE RING CONSTRUCT WITH 2 X RAPID STRUTS SPANNING THE BETWEEN THE FOOTPLATE AND THE DISTAL RING. FOLLOWING A FALL, ONE OF THESE RAPID STRUTS BROKE. THE THREADED ROD FATIGUED MIDWAY DOWN INSIDE THE PLASTIC DICE PORTION. THE ONE STRUT WAS THEN REPLACED WITH TWO OTHERS AND THE FRACTURE REDUCED. THE COMPLAINT REPORT FORM ALSO INDICATED: THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT (LOSS OF FRACTURE REDUCTION). THE INITIAL SURGERY WAS COMPLETED WITH DEVICE. THE EVENT DID NOT LEAD TO A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE SURGICAL PROCEDURE. AN ADDITIONAL SURGERY WAS NOT REQUIRED FOLLOWING DEVICE FAILURE. A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS REQUIRED FOLLOWING DEVICE FAILURE. COPIES OF THE OPERATIVE REPORTS ARE NOT AVAILABLE. COPIES OF THE X-RAYS IMAGES ARE AVAILABLE. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 700178 | TRUE LOK PLUS SHORT QUICK ADJUST STRUT | TRUE LOK PLUS SHORT QUICK ADJUST STRUT | KTT | ORTHOFIX SRL | 50-10170 | V1407236 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Required Intervention |