TL+ TELESCOPIC LINEAR DISTRACTOR 100MM
Report
- Report Number
- 9680825-2016-00089
- Event Type
- Injury
- Date Received
- October 5, 2016
- Date of Event
- September 6, 2016
- Report Date
- October 28, 2016
- Manufacturer
- ORTHOFIX SRL
- Product Code
- LXT
- PMA / PMN Number
- K941048
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER
Narratives
ANALYSIS OF HISTORICAL RECORDS (PLEASE ALSO KINDLY REFER TO MFR REPORT 9680825-2016-00087 AND 9680825-2016-00088). ORTHOFIX (B)(4) CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE DEVICES CODE 50-10140 LOT 23604373. 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 (PLEASE ALSO KINDLY REFER TO MFR REPORT 9680825-2016-00087 AND 9680825-2016-00088). THE RETURNED DEVICES, RECEIVED ON SEPTEMBER 14, 2016, WERE EXAMINED BY ORTHOFIX (B)(4) QUALITY ENGINEERING AREA. THE RETURNED DEVICES WERE SUBJECTED TO VISUAL, DIMENSIONAL AND FUNCTIONAL CHECK AS PER ORTHOFIX SPECIFICATIONS. THE VISUAL CHECK CONFIRMED THE PROBLEM NOTIFIED: "THE BLACK PLASTIC BUSHINGS SLIPPED FROM THEIR SEATS TOWARDS THE THREADED ROD LEAVING EXPOSED THE BARBED TUBE". FURTHERMORE, THE VISUAL CHECK EVIDENCED THAT THE EXTERNAL SURFACE OF ONE DEVICE HAS EVIDENT SIGNS OF DAMAGING. THE DIMENSIONAL CHECK, PERFORMED WHERE POSSIBLE, EVIDENCED THAT THE TEETH OF THE ALUMINIUM TUBE ARE DEFORMED; THIS PROBLEM IS MOST LIKELY OCCURRED DURING THE ASSEMBLING AND RE-ASSEMBLING ACTIVITIES OF THE PLASTIC BUSHING (CODE 50-10170-8). THE DEVICES WERE THEN ASSEMBLED TO PERFORM A TENSION TEST TO REMOVE THE PLASTIC BUSHING ALSO IN COMPARISON WITH DEVICES TAKEN FROM THE STOCK. THIS FUNCTIONAL CHECK EVIDENCED THAT THE RETURNED DEVICES HAVE A LOW RESISTANCE THAN THE DEVICES TAKEN FROM THE STOCK. THIS DIFFERENCE IS MOST LIKELY ATTRIBUTABLE TO THE FACT THAT THE RETURNED DEVICES ALREADY FAILED AND THEREFORE THE TEETH OF THE PLASTIC BUSHING AND OF THE ALUMINIUM TUBE WERE DAMAGED. IN ADDITION THE REASSEMBLING OPERATION MAY HAVE FURTHER DAMAGED THE TEETH. FROM THE EVIDENCES OF THE TECHNICAL INVESTIGATION IT IS NOT POSSIBLE TO DETERMINE WITH PRECISION IF THE DEVICES WERE ORIGINALLY CONFORMING TO SPECIFICATIONS AND IF THIS COULD HAVE CONTRIBUTED TO THE FAILURE NOTIFIED. HOWEVER, THE PRIMARY CAUSE OF FAILURE IS MOST LIKELY TO BE APPLICATION RELATED RATHER THAN DEVICE RELATED. WE MAY SUPPOSE THAT THE STRUTS MAY HAVE BEEN SUBJECTED TO A TENSION LOAD BEYOND DESIGN CRITERIA. MOREOVER, THE DISENGAGEMENT OF THE PLASTIC BUSHING MAY BE MORE LIKELY IF IT IS SUBJECT TO A FLEXURAL LOAD. THIS MAY HAPPEN IF DEVICES ARE NOT USED FOR AN AXIAL APPLICATION AS INTENDED. MEDICAL EVALUATION (PLEASE ALSO KINDLY REFER TO MFR REPORT 9680825-2016-00087 AND 9680825-2016-00088). 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 EVALUATIONS PERFORMED. "I NOTE IN THE TECHNICAL EVALUATION REPORT THAT THE THREADS ON THE STRUTS THAT ENGAGE WITH THE PLASTIC DICE ARE SIGNIFICANTLY DAMAGED. IT IS LIKELY BUT NOT CERTAIN THAT THIS CONTRIBUTED TO THE SUDDEN FAILURE OF THESE DEVICES. THERE IS ALSO A SUGGESTION THAT THESE DEVICES MAY HAVE BEEN SUBJECTED TO A BENDING LOAD IN COMBINATION WITH THE AXIAL LOAD AND THIS MAY HAVE CONTRIBUTED TO THE FAILURE. THE FAILURES OCCURRED DURING INTRAOPERATIVE MANIPULATION, AND WERE EASILY REPLACED WITH OTHER UNITS. THE DELAY OF 30 MINUTES IS NOT UNCOMMON DURING A LIMB RECONSTRUCTION OPERATION". FINAL COMMENTS (PLEASE ALSO KINDLY REFER TO MFR REPORT 9680825-2016-00087 AND 9680825-2016-00088). FROM THE EVIDENCES OF THE TECHNICAL INVESTIGATION IT IS NOT POSSIBLE TO DETERMINE WITH PRECISION IF THE DEVICES WERE ORIGINALLY CONFORMING TO SPECIFICATIONS AND IF THIS COULD HAVE CONTRIBUTED TO THE FAILURE NOTIFIED. HOWEVER, THE PRIMARY CAUSE OF FAILURE IS MOST LIKELY TO BE APPLICATION RELATED RATHER THAN DEVICE RELATED. WE MAY SUPPOSE THAT THE STRUTS MAY HAVE BEEN SUBJECTED TO A TENSION LOAD BEYOND DESIGN CRITERIA. MOREOVER, THE DISENGAGEMENT OF THE PLASTIC BUSHING MAY BE MORE LIKELY IF IT IS SUBJECT TO A FLEXURAL LOAD. THIS MAY HAPPEN IF DEVICES ARE NOT USED FOR AN AXIAL APPLICATION AS INTENDED. THE MEDICAL EVALUATION EVIDENCED AS FOLLOWS: "I NOTE IN THE TECHNICAL EVALUATION REPORT THAT THE THREADS ON THE STRUTS THAT ENGAGE WITH THE PLASTIC DICE ARE SIGNIFICANTLY DAMAGED. IT IS LIKELY BUT NOT CERTAIN THAT THIS CONTRIBUTED TO THE SUDDEN FAILURE OF THESE DEVICES. THERE IS ALSO A SUGGESTION THAT THESE DEVICES MAY HAVE BEEN SUBJECTED TO A BENDING LOAD IN COMBINATION WITH THE AXIAL LOAD AND THIS MAY HAVE CONTRIBUTED TO THE FAILURE. THE FAILURES OCCURRED DURING INTRAOPERATIVE MANIPULATION, AND WERE EASILY REPLACED WITH OTHER UNITS. THE DELAY OF 30 MINUTES IS NOT UNCOMMON DURING A LIMB RECONSTRUCTION OPERATION". BASED ON THE RESULTS OF THE TECHNICAL EVALUATION AND ON THE EVIDENCES DERIVING FROM THE MEDICAL EVALUATION, ORTHOFIX (B)(4) CAN CONCLUDE THAT THESE DEVICES HAVE BEEN SUBJECTED TO LOADS BEYOND THE DESIGN CRITERIA OR TO FLEXURAL COMPONENT. ORTHOFIX (B)(4) CONTINUES MONITORING THE DEVICES ON THE MARKET. PLEASE ALSO KINDLY REFER TO MFR REPORTS 9680825-2016-00087 AND 9680825-2016-00088.
ANALYSIS OF HISTORICAL RECORDS (PLEASE ALSO KINDLY REFER TO MFR REPORT 9680825-2016-00087 AND 9680825-2016-00088). ORTHOFIX (B)(4) CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE DEVICES CODE 50-10140 LOT 23604373. 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 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 TECHNICAL EVALUATION BECOME 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 9680825-2016-00087 AND 9680825-2016-00088. DEVICE UNDER TECHNICAL EVALUATION.
THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: DEVICES CODE: 50-10140 (TL+ TELESCOPIC LINEAR DISTRACTOR 100MM); DEVICES LOT: 23604373; QUANTITY: 3 (PLEASE ALSO KINDLY REFER TO MFR REPORTS 9680825-2016-00087 AND 9680825-2016-00088); HOSPITAL NAME: (B)(6); SURGEON NAME: PROF. (B)(6); DATE OF THE INITIAL SURGERY: (B)(6) 2016; SITE OF APPLICATION: ANKLE; SURGERY DESCRIPTION: NOT PROVIDED; PATIENT INFORMATION: FEMALE, PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT; TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM; EVENT DESCRIPTION: AT THE END OF THE FIXATOR POSITIONING FOR AN ANKLE ARTHRODESIS, DURING THE COMPRESSION MANOEUVRES (COMPRESSION EXPECTED OF ABOUT 2 MM) BY MEANS OF THESE TELESCOPIC RODS, THE BLACK PLASTIC BUSHINGS SLIPPED FROM THEIR SEATS TOWARDS THE THREADED ROD LEAVING EXPOSED THE THREAD. DUE TO THIS PROBLEM 3 OUT OF 4 RODS INITIALLY USED HAD TO BE REPLACED. THE COMPLAINT REPORT FORM ALSO INDICATES: - THE DEVICE FAILURE DID NOT HAVE ANY ADVERSE EFFECTS TO PATIENT; - THE INITIAL SURGERY WAS NOT COMPLETED WITH THE DEVICES; - REPLACEMENT DEVICES WERE IMMEDIATELY AVAILABLE TO COMPLETE THE SURGERY; - THE EVENT OCCURRED LED TO A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE SURGICAL PROCEDURE: 30 MINUTES DELAY FOR THE DEVICES REPLACEMENT. - AN ADDITIONAL SURGERY WAS NOT REQUIRED. - COPIES OF THE OPERATIVE REPORT ARE NOT AVAILABLE. - COPIES OF THE X-RAYS IMAGES ARE NOT AVAILABLE. - INFORMATION ABOUT PATIENT CURRENT HEALTH CONDITION: NOT AVAILABLE. PLEASE ALSO KINDLY REFER TO MFR REPORT 9680825-2016-00087 AND 9680825-2016-00088. MANUFACTURER REFERENCE NUMBER: (B)(4).
THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: DEVICES CODE: 50-10140 (TL+ TELESCOPIC LINEAR DISTRACTOR 100MM); DEVICES LOT: 23604373; QUANTITY: 3 (PLEASE ALSO KINDLY REFER TO MFR REPORTS 9680825-2016-00087 AND 9680825-2016-00088); HOSPITAL NAME: (B)(6); SURGEON NAME: PROF. (B)(6); DATE OF THE INITIAL SURGERY: (B)(6) 2016; SITE OF APPLICATION: ANKLE; SURGERY DESCRIPTION: NOT PROVIDED; PATIENT INFORMATION: FEMALE. PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT; TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM; EVENT DESCRIPTION: AT THE END OF THE FIXATOR POSITIONING FOR AN ANKLE ARTHRODESIS, DURING THE COMPRESSION MANOEUVRES (COMPRESSION EXPECTED OF ABOUT 2 MM) BY MEANS OF THESE TELESCOPIC RODS, THE BLACK PLASTIC BUSHINGS SLIPPED FROM THEIR SEATS TOWARDS THE THREADED ROD LEAVING EXPOSED THE THREAD. DUE TO THIS PROBLEM 3 OUT OF 4 RODS INITIALLY USED HAD TO BE REPLACED. THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE DID NOT HAVE ANY ADVERSE EFFECTS TO PATIENT; THE INITIAL SURGERY WAS NOT COMPLETED WITH THE DEVICES; REPLACEMENT DEVICES WERE IMMEDIATELY AVAILABLE TO COMPLETE THE SURGERY; THE EVENT OCCURRED LED TO A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE SURGICAL PROCEDURE: 30 MINUTES DELAY FOR THE DEVICES REPLACEMENT. AN ADDITIONAL SURGERY WAS NOT REQUIRED. COPIES OF THE OPERATIVE REPORT ARE NOT AVAILABLE. COPIES OF THE X-RAYS IMAGES ARE NOT AVAILABLE. INFORMATION ABOUT PATIENT CURRENT HEALTH CONDITION: NOT AVAILABLE. PLEASE ALSO KINDLY REFER TO MFR REPORT 9680825-2016-00087 AND 9680825-2016-00088. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 653386 | TL+ TELESCOPIC LINEAR DISTRACTOR 100MM | TL+ TELESCOPIC LINEAR DISTRACTOR 100MM | LXT | ORTHOFIX SRL | 50-10140 | 23604373 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |