MODULAR 5/8 RING, 160MM, TL-HEX
Report
- Report Number
- 9680825-2016-00043
- Event Type
- Injury
- Date Received
- April 27, 2016
- Date of Event
- March 30, 2016
- Report Date
- June 27, 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 (PLEASE ALSO KINDLY REFER TO MFR REPORTS 9680825-2016-00042, 9680825-2016-00044 AND 9680825-2016-00048). ORTHOFIX (B)(4) CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE DEVICES CODE 56-21420 BATCH (B)(4) 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, NO OTHER SIMILAR NOTIFICATIONS HAVE BEEN RECEIVED ON THIS SPECIFIC DEVICE CODE. ORTHOFIX (B)(4) CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE DEVICES CODE 50-10300 BATCH (B)(4) BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2013, WAS COMPRISED OF (B)(4) DEVICES. ALL OF THEM HAVE ALREADY BEEN DISTRIBUTED TO THE MARKET. ACCORDING TO ORTHOFIX (B)(4) HISTORICAL RECORDS, NO OTHER SIMILAR NOTIFICATIONS HAVE BEEN RECEIVED ON THIS SPECIFIC DEVICE CODE. AS REGARDS THE OTHER STRUT INVOLVED IN THIS INCIDENT (CODE 50-10100) WE ARE CURRENTLY VERIFYING THE LOT INVOLVED. AS SOON AS THE LOT IS IDENTIFIED, WE WILL PERFORM THE VERIFICATION OF THE HISTORICAL DATA. TECHNICAL EVALUATION (PLEASE ALSO KINDLY REFER TO MFR REPORTS 9680825-2016-00042, 9680825-2016-00044 AND 9680825-2016-00048). THE FIRST RING, WHICH MALFUNCTIONED DURING THE APPLICATION, WAS RECEIVED ON APRIL 18, 2016 AND IS CURRENTLY UNDER TECHNICAL EVALUATION (PLEASE KINDLY REFER TO MFR REPORT 9680825-2016-00042). THE STRUT CODE 50-10300 WILL BE SENT TO ORTHOFIX (B)(4) FOR THE TECHNICAL EVALUATION AT THE END OF THE DECONTAMINATION ACTIVITIES, CURRENTLY ON GOING BY THE HOSPITAL INVOLVED (PLEASE ALSO KINDLY REFER TO MFR REPORT 9680825-2016-00048). THE OTHER TWO DEVICES ARE CURRENTLY IN USE BY PATIENT AND THEREFORE NOT AVAILABLE FOR THE TECHNICAL EVALUATION. THE TECHNICAL EVALUATION OF THESE DEVICES WILL BE PERFORMED AS SOON AS THEY BECOME AVAILABLE (PLEASE KINDLY REFER TO MFR REPORT 9680825-2016-00043 AND 9680825-2016-00044). MEDICAL EVALUATION: THE INFORMATION MADE AVAILABLE ON THE EVENT 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 FURTHER INFORMATION 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 9680825-2016-00042, 9680825-2016-00044 AND 9680825-2016-00048.
ANALYSIS OF HISTORICAL RECORDS RINGS: ORTHOFIX (B)(4) CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE RINGS CODE 56-21420 BATCH V1404314 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, NO OTHER NOTIFICATIONS HAVE BEEN RECEIVED ON THIS SPECIFIC DEVICE CODE (PLEASE ALSO KINDLY REFER TO MFR REPORTS 9680825-2016-00042 AND 9680825-2016-00043). STRUT WHICH JAMMED: ORTHOFIX (B)(4) CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE STRUTS CODE 50-10300 BATCH V1340916 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2013, WAS COMPRISED OF (B)(4) DEVICES. ALL OF THEM HAVE ALREADY BEEN DISTRIBUTED TO THE MARKET. ACCORDING TO ORTHOFIX (B)(4) HISTORICAL RECORDS, NO OTHER NOTIFICATIONS HAVE BEEN RECEIVED ON THIS SPECIFIC DEVICE LOT (PLEASE ALSO KINDLY REFER TO MFR REPORT 9680825-2016-00048). STRUT WHICH POPPED OUT: ORTHOFIX (B)(4) CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE STRUTS CODE 50-10200 BATCH V1338121 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2013, WAS COMPRISED OF (B)(4) DEVICES. ALL OF THEM HAVE ALREADY BEEN DISTRIBUTED TO THE MARKET. ACCORDING TO ORTHOFIX (B)(4) HISTORICAL RECORDS, NO OTHER NOTIFICATIONS HAVE BEEN RECEIVED ON THIS SPECIFIC DEVICE LOT (PLEASE ALSO KINDLY REFER TO MFR REPORT 9680825-2016-00044). TECHNICAL EVALUATION: THE FIRST RING WHICH MALFUNCTIONED DURING THE APPLICATION, CODE 56-21420 LOT V1404314, WAS RECEIVED ON APRIL 18TH, 2016. THE DEVICE WAS EXAMINED BY ORTHOFIX (B)(4) QUALITY ENGINEERING AREA (PLEASE KINDLY REFER TO MFR REPORT 9680825-2016-00042). THE STRUT WHICH JAMMED, CODE 50-10300 LOT V1340916, WAS RECEIVED ON JUNE 10TH, 2016. THE DEVICE WAS EXAMINED BY ORTHOFIX (B)(4) QUALITY ENGINEERING AREA (PLEASE KINDLY REFER TO MFR REPORT 9680825-2016-00048). THE OTHER TWO DEVICES INVOLVED, SECOND RING CODE 56-21420 LOT V1404314 AND STRUT CODE 50-10200 LOT V1338121, ARE CURRENTLY IN USE BY PATIENT. THE TECHNICAL EVALUATION OF THESE DEVICES WILL BE PERFORMED AS SOON AS THEY BECOME AVAILABLE (PLEASE ALSO KINDLY REFER TO MFR REPORTS 9680825-2016-00043 AND 9680825-2016-00044). THE RETURNED DEVICES WERE SUBJECTED TO VISUAL, DIMENSIONAL AND FUNCTIONAL CHECK AS PER ORTHOFIX (B)(4) SPECIFICATIONS. THE VISUAL CHECK OF THE RING EVIDENCED THAT ONE OF THE SET SCREWS WAS TAKEN OUT FROM ITS SEAT WHILE ANOTHER SET SCREW WAS FORCED TO EXIT AND, AS A RESULT, THE LAST THREAD OF THE RING, WHERE PEENING IS PERFORMED, WAS ALSO DAMAGED . THE DIMENSIONAL CHECK, PERFORMED ON BOTH RETURNED DEVICES, DID NOT EVIDENCE ANY ANOMALIES. THE FUNCTIONAL CHECK OF THE RING WAS THEN PERFORMED WITH THE EXCEPTION OF TWO DAMAGED THREADED SEATS OF THE SET SCREWS. THE CHECK WAS PERFORMED USING THE RETURNED STRUT WITHOUT FINDING ANY ANOMALIES. THE FUNCTIONAL CHECK OF THE RETURNED STRUT WAS ALSO PERFORMED WITH THE FOLLOWING RESULTS: THE ACUTE ADJUSTMENT WORKS PROPERLY. THE INNER TUBE COULD SLIDE EASILY INSIDE THE OUTER TUBE AND THE LOCKING BOLT FUNCTIONED CORRECTLY; THE GRADUAL ADJUSTMENT WORKS PROPERLY; THE STUDS ROTATE EASILY IN THEIR SEATS. THE RESULTS OF THE TECHNICAL EVALUATION EVIDENCED THAT THE TWO RETURNED DEVICES WERE ORIGINALLY CONFORMING TO ORTHOFIX (B)(4) SPECIFICATIONS. THE PROBLEM OCCURRED IS MOST LIKELY ATTRIBUTABLE TO THE SPECIFIC APPLICATION. A PARTIAL EXPLANATION REGARDING THE TWO DAMAGED SET SCREWS IS THAT IT WAS TRIED TO REMOVE THEM THUS CAUSING THE DAMAGING OF THEIR THREADED SEATS. THIS MAY HAVE CAUSED THE IMPOSSIBILITY TO TIGHTEN THE STRUTS IN THEIR POSITIONS. 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. ON (B)(6) 2016: "IN THIS CASE A (B)(6) PATIENT WAS HAVING A CORRECTION TO THE FOOT WITH THE TL-HEX SYSTEM. WE ARE TOLD THAT ONE SET OF STRUTS POPPED OUT AT ABOUT ONE WEEK, AND WAS IMMEDIATELY REPLACED BY THE SURGEON AND LOCKED WITH THE TORQUE WRENCH. NO ADVERSE EFFECT WAS NOTED AND TREATMENT CONTINUES. FURTHER DETAILS ARE NOT CURRENTLY AVAILABLE." ON (B)(6) 2016 WITH THE RESULTS OF THE TECHNICAL EVALUATION: "THE TECHNICAL EVALUATION SHOWS THAT THE SET SCREWS HAD BEEN PARTIALLY REMOVED FROM THE RING IN 2 LOCATIONS, BUT IN THE REMAINING LOCATIONS THE SET SCREWS AND THE STUDS PERFORMED QUITE NORMALLY. NO CAUSE FOR THE SET SCREWS COMING LOOSE WAS FOUND AND THEREFORE IT WAS CONCLUDED THAT THE CAUSE WAS INCORRECT USE. THE ORIGINAL COMPLAINT FORM DOES NOT STATE THAT THE SURGEON DEFINITELY USED THE TORQUE WRENCH DURING THE ORIGINAL APPLICATION, BUT THAT THE SURGEON AND THE REPRESENTATIVE USED THE TORQUE WRENCH THE SECOND TIME, AFTER WHICH THE PROBLEM DID NOT RECUR. THE TECHNICAL EVALUATION ALSO SHOWS THAT 2 OF THE 5 SET SCREWS IN THE RETURNED RING HAD BEEN PARTIALLY REMOVED. THEY WOULD NOT HAVE WORKED PROPERLY AFTER THIS TREATMENT. ALL THE DIMENSIONS OF THE RING THAT COULD BE TESTED WERE CORRECT. I AGREE THAT THE CONCLUSION OF THE REPORT SEEMS VERY REASONABLE, AND IT IS LIKELY THAT THIS CAUSE OF THE FAILURE WAS INCORRECT USE." FINAL COMMENTS: THE RESULTS OF THE TECHNICAL EVALUATION EVIDENCED THAT THE TWO RETURNED DEVICES WERE ORIGINALLY CONFORMING TO ORTHOFIX (B)(4) SPECIFICATIONS. THE PROBLEM OCCURRED IS MOST LIKELY ATTRIBUTABLE TO THE SPECIFIC APPLICATION. A PARTIAL EXPLANATION REGARDING THE TWO DAMAGED SET SCREWS IS THAT IT WAS TRIED TO REMOVE THEM THUS CAUSING THE DAMAGING OF THEIR THREADED SEATS. THIS MAY HAVE CAUSED THE IMPOSSIBILITY TO TIGHTEN THE STRUTS IN THEIR POSITIONS. THE MEDICAL EVALUATION EVIDENCED AS FOLLOW: "IN THIS CASE A (B)(6) PATIENT WAS HAVING A CORRECTION TO THE FOOT WITH THE TL-HEX SYSTEM. WE ARE TOLD THAT ONE SET OF STRUTS POPPED OUT AT ABOUT ONE WEEK, AND WAS IMMEDIATELY REPLACED BY THE SURGEON AND LOCKED WITH THE TORQUE WRENCH. NO ADVERSE EFFECT WAS NOTED AND TREATMENT CONTINUES. THE TECHNICAL EVALUATION SHOWS THAT THE SET SCREWS HAD BEEN PARTIALLY REMOVED FROM THE RING IN 2 LOCATIONS, BUT IN THE REMAINING LOCATIONS THE SET SCREWS AND THE STUDS PERFORMED QUITE NORMALLY. NO CAUSE FOR THE SET SCREWS COMING LOOSE WAS FOUND AND THEREFORE IT WAS CONCLUDED THAT THE CAUSE WAS INCORRECT USE. THE ORIGINAL COMPLAINT FORM DOES NOT STATE THAT THE SURGEON DEFINITELY USED THE TORQUE WRENCH DURING THE ORIGINAL APPLICATION, BUT THAT THE SURGEON AND THE REPRESENTATIVE USED THE TORQUE WRENCH THE SECOND TIME, AFTER WHICH THE PROBLEM DID NOT RECUR. THE TECHNICAL EVALUATION ALSO SHOWS THAT 2 OF THE 5 SET SCREWS IN THE RETURNED RING HAD BEEN PARTIALLY REMOVED. THEY WOULD NOT HAVE WORKED PROPERLY AFTER THIS TREATMENT. ALL THE DIMENSIONS OF THE RING THAT COULD BE TESTED WERE CORRECT. I AGREE THAT THE CONCLUSION OF THE REPORT SEEMS VERY REASONABLE, AND IT IS LIKELY THAT THIS CAUSE OF THE FAILURE WAS INCORRECT USE". BASED ON THE RESULTS OF THE TECHNICAL EVALUATION AND ON THE EVIDENCES DERIVING FROM THE MEDICAL EVALUATION, ORTHOFIX (B)(4) CAN CONCLUDE THAT THE PROBLEM THAT OCCURRED IS NOT DEVICE RELATED BUT IS MOST LIKELY ATTRIBUTABLE TO THE SPECIFIC APPLICATION. IN CASE FURTHER INFORMATION AND/OR THE OTHER TWO DEVICES INVOLVED ARE PROVIDED, ORTHOFIX (B)(4) WILL PROMPTLY RE-OPEN THE INVESTIGATION. ORTHOFIX (B)(4) CONTINUES MONITORING THE DEVICES ON THE MARKET.
ANALYSIS OF HISTORICAL RECORDS (PLEASE ALSO KINDLY REFER TO MFR REPORT 9680825-2016-00042 AND 9680825-2016-00044). ORTHOFIX (B)(4) CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE DEVICES CODE 56-21420 BATCH V1404314 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, NO OTHER SIMILAR NOTIFICATIONS HAVE BEEN RECEIVED ON THIS SPECIFIC DEVICE CODE. THE STRUT INVOLVED IN THIS EVENT IS CURRENTLY IN USE BY PATIENT. UNFORTUNATELY THE CODE AND LOT NUMBER HAS NOT BEEN MADE AVAILABLE, THEREFORE IT WAS NOT POSSIBLE TO PERFORM THE VERIFICATION OF THE HISTORICAL DATA. TECHNICAL EVALUATION: THE FIRST RING, WHICH MALFUNCTIONED DURING THE APPLICATION, WAS RECEIVED ON APRIL 18, 2016 AND IS CURRENTLY UNDER TECHNICAL EVALUATION (PLEASE KINDLY REFER TO MFR REPORT 9680825-2016-00042). THE OTHER TWO DEVICES ARE CURRENTLY IN USE BY PATIENT AND THEREFORE NOT AVAILABLE FOR THE TECHNICAL EVALUATION. THE TECHNICAL EVALUATION OF THESE DEVICES WILL BE PERFORMED AS SOON AS THEY BECOME AVAILABLE (PLEASE KINDLY REFER TO MFR REPORT 9680825-2016-00043 AND 9680825-2016-00044). MEDICAL EVALUATION: THE INFORMATION MADE AVAILABLE ON THE EVENT 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 FURTHER INFORMATION 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 9680825-2016-00042 AND 9680825-2016-00044. DEVICE CURRENTLY IN USE BY PATIENT.
THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: PRODUCT CODE: TWO TL-HEX RING CODE 56-21420 AND ONE TL-HEX STRUT (PLEASE ALSO KINDLY REFER TO MFR REPORTS 9680825-2016-00042 AND 9680825-2016-00044). HOSPITAL NAME: (B)(6). SURGEON NAME: MR (B)(6). DATE OF SURGERY: (B)(6) 2016. BODY PART TO WHICH DEVICE WAS APPLIED: FOOT. SURGERY DESCRIPTION: CORRECTION. PATIENT INFORMATION: (B)(6), MALE. PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE (FIRST RING) AND INTO TREATMENT/POST-OPERATIVE (SECOND RING AND STRUT). TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: PROBLEM OCCURRED DURING APPLICATION: THE SURGEON SELECTED THE RING (CODE 56-21420 LOT V1404314), SIZED IT UP AGAINST THE PATIENT'S LEG, THEN GOT THE STRUTS TO START CONSTRUCTING THE HEXAPOD HOWEVER, WHEN THE STRUT HEADS WERE CORRECTLY INSERTED INTO THE TAB, WHEN THE SURGEON TRIED TO TIGHTEN DOWN THE GRUB SCREW, THEY STRUTS KEPT FALLING OUT. HE REPEATED THIS PROCESS 3 TIMES & THEN PASSED THE RING OUT THE STERILE FIELD TO (B)(6) WHO RETURNED TO OFFICE. THE STRUTS WERE PLACED CORRECTLY, THE RING DID NOT SUSTAIN ANY DAMAGE COMING OUT OF THE TRAY. PROBLEM OCCURRED INTO TREATMENT: I WANTED TO MAKE YOU AWARE THAT I HAVE NOTED ANOTHER INCIDENT OF TL-HEX STRUTS POPPING OUT FROM THEIR MOUNTINGS ON A TL-HEX FRAME. IT APPEARED THAT THE SET-SCREW OF THE RING (CODE 56-21420 LOT V1404314) HAD COME LOOSE/BACKED OUT. I CAN CONFIRM THAT THE CORRECT OP-TECH HAD BEEN FOLLOWED DURING THE FRAME APPLICATION NINE DAYS PREVIOUS. THE SURGEON (MR (B)(6), (B)(4)) AND I RE-INSERTED THE STRUTS, TIGHTENED THE SET-SCREW, AND CHECKED IT WITH THE TORQUE WRENCH YESTERDAY. THE STRUTS APPEARED TO BE STABLE AND WELL ANCHORED IN THEIR MOUNT. THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICES FAILURE DID NOT HAVE ANY ADVERSE EFFECTS ON PATIENT. THE SURGERY WAS COMPLETED WITH THE USED DEVICES. THE EVENT DID NOT LEAD TO A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE SURGICAL PROCEDURE. AN ADDITIONAL SURGERY WAS NOT REQUIRED. COPIES OF THE OPERATIVE REPORTS ARE NOT AVAILABLE. COPIES OF THE X-RAYS IMAGES ARE NOT AVAILABLE. PATIENT CURRENT HEALTH CONDITION: NO INFORMATION. ON APRIL 27, 2016 ORTHOFIX (B)(4) RECEIVED FROM THE LOCAL DISTRIBUTOR A REVISED COMPLAINT REPORT FORM WHICH INCLUDED THE FOLLOWING ADDITIONAL INFORMATION: PRODUCT CODE: 2 RINGS CODE 56-21420 LOT V1404314; 1 STRUT CODE 50-10100 LOT UNDER VERIFICATION; 1 STRUT CODE 50-10300 LOT V1340916. PATIENT PREVIOUS HEALTH CONDITIONS: CLUB FOOT (BILATERAL) ONE ALREADY TREATED. EVENT DESCRIPTION: PROBLEM OCCURRED DURING APPLICATION: THE SURGEON SELECTED THE RING (CODE 56-21420 LOT V1404314), SIZED IT UP AGAINST THE PATIENT'S LEG, THEN GOT THE STRUTS TO START CONSTRUCTING THE HEXAPOD HOWEVER, WHEN THE STRUT HEADS WERE CORRECTLY INSERTED INTO THE TAB, WHEN THE SURGEON TRIED TO TIGHTEN DOWN THE GRUB SCREW, THEY STRUTS KEPT FALLING OUT. HE REPEATED THIS PROCESS 3 TIMES & THEN PASSED THE RING OUT THE STERILE FIELD TO (B)(6) WHO RETURNED TO OFFICE. THE STRUTS WERE PLACED CORRECTLY, THE RING DID NOT SUSTAIN ANY DAMAGE COMING OUT OF THE TRAY. PROBLEM OCCURRED INTO TREATMENT: I WANTED TO MAKE YOU AWARE THAT I HAVE NOTED ANOTHER INCIDENT OF TL-HEX STRUTS (CODE 50-10100, LOT UNDER VERIFICATION) POPPING OUT FROM THEIR MOUNTINGS ON A TL-HEX FRAME. IT APPEARED THAT THE SET-SCREW OF THE RING (CODE 56-21420, LOT V1404314) HAD COME LOOSE/BACKED OUT. I CAN CONFIRM THAT THE CORRECT OP-TECH HAD BEEN FOLLOWED DURING THE FRAME APPLICATION NINE DAYS PREVIOUS. THE SURGEON (MR PAGE, DURHAM) AND I RE-INSERTED THE STRUTS, TIGHTENED THE SET-SCREW, AND CHECKED IT WITH THE TORQUE WRENCH YESTERDAY. THE STRUTS APPEARED TO BE STABLE AND WELL ANCHORED IN THEIR MOUNT. THE HEX STRUT CODE 50-10300 (LOT V1340916) HAD JAMMED AND WOULD HAVE TO BE REPLACED. THE STRUT WILL BE RETURNED FOR FURTHER INVESTIGATION. PLEASE ALSO KINDLY REFER TO MFR REPORT 9680825-2016-00042, 9680825-2016-00044 AND 9680825-2016-00048. (B)(4).
THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: PRODUCT CODE: TWO TL-HEX RING CODE 56-21420 AND ONE TL-HEX STRUT (PLEASE ALSO KINDLY REFER TO MFR REPORTS 9680825-2016-00042 AND 9680825-2016-00044). HOSPITAL NAME: (B)(6). SURGEON NAME: MR (B)(6). DATE OF SURGERY: (B)(6) 2016. BODY PART TO WHICH DEVICE WAS APPLIED: FOOT. SURGERY DESCRIPTION: CORRECTION. PATIENT INFORMATION: (B)(6) MALE. PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE (FIRST RING) AND INTO TREATMENT/POST-OPERATIVE (SECOND RING AND STRUT). TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: PROBLEM OCCURRED DURING APPLICATION: THE SURGEON SELECTED THE RING (CODE 56-21420 LOT V1404314), SIZED IT UP AGAINST THE PATIENT'S LEG, THEN GOT THE STRUTS TO START CONSTRUCTING THE HEXAPOD; HOWEVER, WHEN THE STRUT HEADS WERE CORRECTLY INSERTED INTO THE TAB, WHEN THE SURGEON TRIED TO TIGHTEN DOWN THE GRUB SCREW, THEY STRUTS KEPT FALLING OUT. HE REPEATED THIS PROCESS 3 TIMES & THEN PASSED THE RING OUT THE STERILE FIELD TO G. WHITE WHO RETURNED TO OFFICE. THE STRUTS WERE PLACED CORRECTLY, THE RING DID NOT SUSTAIN ANY DAMAGE COMING OUT OF THE TRAY. PROBLEM OCCURRED INTO TREATMENT: I WANTED TO MAKE YOU AWARE THAT I HAVE NOTED ANOTHER INCIDENT OF TL-HEX STRUTS POPPING OUT FROM THEIR MOUNTINGS ON A TL-HEX FRAME. IT APPEARED THAT THE SET-SCREW OF THE RING (CODE 56-21420 LOT V1404314) HAD COME LOOSE/BACKED OUT. I CAN CONFIRM THAT THE CORRECT OP-TECH HAD BEEN FOLLOWED DURING THE FRAME APPLICATION NINE DAYS PREVIOUS. THE SURGEON (MR (B)(6)) AND I RE-INSERTED THE STRUTS, TIGHTENED THE SET-SCREW, AND CHECKED IT WITH THE TORQUE WRENCH YESTERDAY. THE STRUTS APPEARED TO BE STABLE AND WELL ANCHORED IN THEIR MOUNT. THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICES FAILURE DID NOT HAVE ANY ADVERSE EFFECTS ON PATIENT. THE SURGERY WAS COMPLETED WITH THE USED DEVICES. THE EVENT DID NOT LEAD TO A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE SURGICAL PROCEDURE. AN ADDITIONAL SURGERY WAS NOT REQUIRED. COPIES OF THE OPERATIVE REPORTS ARE NOT AVAILABLE. COPIES OF THE X-RAYS IMAGES ARE NOT AVAILABLE. PATIENT CURRENT HEALTH CONDITION: NO INFORMATION. ON APRIL 27, 2016 ORTHOFIX (B)(4) RECEIVED FROM THE LOCAL DISTRIBUTOR A REVISED COMPLAINT REPORT FORM WHICH INCLUDED THE FOLLOWING ADDITIONAL INFORMATION: PRODUCT CODE: 2 RINGS CODE 56-21420 LOT V1404314; 1 STRUT CODE 50-10100 LOT UNDER VERIFICATION; 1 STRUT CODE 50-10300 LOT V1340916. PATIENT PREVIOUS HEALTH CONDITIONS: CLUB FOOT (BILATERAL) ONE ALREADY TREATED. EVENT DESCRIPTION: PROBLEM OCCURRED DURING APPLICATION: THE SURGEON SELECTED THE RING (CODE 56-21420 LOT V1404314), SIZED IT UP AGAINST THE PATIENT'S LEG, THEN GOT THE STRUTS TO START CONSTRUCTING THE HEXAPOD; HOWEVER, WHEN THE STRUT HEADS WERE CORRECTLY INSERTED INTO THE TAB, WHEN THE SURGEON TRIED TO TIGHTEN DOWN THE GRUB SCREW, THEY STRUTS KEPT FALLING OUT. HE REPEATED THIS PROCESS 3 TIMES & THEN PASSED THE RING OUT THE STERILE FIELD TO G. WHITE WHO RETURNED TO OFFICE. THE STRUTS WERE PLACED CORRECTLY, THE RING DID NOT SUSTAIN ANY DAMAGE COMING OUT OF THE TRAY. PROBLEM OCCURRED INTO TREATMENT: I WANTED TO MAKE YOU AWARE THAT I HAVE NOTED ANOTHER INCIDENT OF TL-HEX STRUTS (CODE 50-10100, LOT UNDER VERIFICATION) POPPING OUT FROM THEIR MOUNTINGS ON A TL-HEX FRAME. IT APPEARED THAT THE SET-SCREW OF THE RING (CODE 56-21420, LOT V1404314) HAD COME LOOSE/BACKED OUT. I CAN CONFIRM THAT THE CORRECT OP-TECH HAD BEEN FOLLOWED DURING THE FRAME APPLICATION NINE DAYS PREVIOUS. THE SURGEON (MR (B)(6)) AND I RE-INSERTED THE STRUTS, TIGHTENED THE SET-SCREW, AND CHECKED IT WITH THE TORQUE WRENCH YESTERDAY. THE STRUTS APPEARED TO BE STABLE AND WELL ANCHORED IN THEIR MOUNT. THE HEX STRUT CODE 50-10300 (LOT V1340916) HAD JAMMED AND WOULD HAVE TO BE REPLACED. THE STRUT WILL BE RETURNED FOR FURTHER INVESTIGATION (PLEASE ALSO KINDLY REFER TO MFR REPORT 9680825-2016-00048). ON JUNE 15TH, 2016 ORTHOFIX (B)(4) RECEIVED FROM THE LOCAL DISTRIBUTOR THE FOLLOWING INFORMATION: "THE CODE OF THE POPPING STRUT ACTUALLY IS 50-10200 AND LOT V1338121" (PLEASE ALSO KINDLY REFER TO MFR REPORT 9680825-2016-00044). PLEASE ALSO KINDLY REFER TO MFR REPORT 9680825-2016-00042, 9680825-2016-00044 AND 9680825-2016-00048. (B)(4).
THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: PRODUCT CODE: TWO TL-HEX RING CODE 56-21420 AND ONE TL-HEX STRUT (PLEASE ALSO KINDLY REFER TO MFR REPORTS 9680825-2016-00042 AND 9680825-2016-00044). (B)(6). BODY PART TO WHICH DEVICE WAS APPLIED: FOOT. SURGERY DESCRIPTION: CORRECTION. PATIENT INFORMATION: (B)(6), MALE. PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE (FIRST RING) AND INTO TREATMENT/POST-OPERATIVE (SECOND RING AND STRUT). TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: PROBLEM OCCURRED DURING APPLICATION: THE SURGEON SELECTED THE RING (CODE 56-21420 LOT V1404314), SIZED IT UP AGAINST THE PATIENT'S LEG, THEN GOT THE STRUTS TO START CONSTRUCTING THE HEXAPOD HOWEVER, WHEN THE STRUT HEADS WERE CORRECTLY INSERTED INTO THE TAB, WHEN THE SURGEON TRIED TO TIGHTEN DOWN THE GRUB SCREW, THEY STRUTS KEPT FALLING OUT. HE REPEATED THIS PROCESS 3 TIMES & THEN PASSED THE RING OUT THE STERILE FIELD TO (B)(6) WHO RETURNED TO OFFICE. THE STRUTS WERE PLACED CORRECTLY, THE RING DID NOT SUSTAIN ANY DAMAGE COMING OUT OF THE TRAY. PROBLEM OCCURRED INTO TREATMENT: I WANTED TO MAKE YOU AWARE THAT I HAVE NOTED ANOTHER INCIDENT OF TL-HEX STRUTS POPPING OUT FROM THEIR MOUNTINGS ON A TL-HEX FRAME. IT APPEARED THAT THE SET-SCREW OF THE RING (CODE 56-21420 LOT V1404314) HAD COME LOOSE/BACKED OUT. I CAN CONFIRM THAT THE CORRECT OP-TECH HAD BEEN FOLLOWED DURING THE FRAME APPLICATION NINE DAYS PREVIOUS. THE SURGEON (B)(6) AND I RE-INSERTED THE STRUTS, TIGHTENED THE SET-SCREW, AND CHECKED IT WITH THE TORQUE WRENCH YESTERDAY. THE STRUTS APPEARED TO BE STABLE AND WELL ANCHORED IN THEIR MOUNT. THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICES FAILURE DID NOT HAVE ANY ADVERSE EFFECTS ON PATIENT. THE SURGERY WAS COMPLETED WITH THE USED DEVICES. THE EVENT DID NOT LEAD TO A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE SURGICAL PROCEDURE. AN ADDITIONAL SURGERY WAS NOT REQUIRED. COPIES OF THE OPERATIVE REPORTS ARE NOT AVAILABLE. COPIES OF THE X-RAYS IMAGES ARE NOT AVAILABLE. PATIENT CURRENT HEALTH CONDITION: NO INFORMATION. PLEASE ALSO KINDLY REFER TO MFR REPORT 9680825-2016-00042 AND 9680825-2016-00044. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 266646 | MODULAR 5/8 RING, 160MM, TL-HEX | MODULAR 5/8 RING, 160MM, TL-HEX | KTT | ORTHOFIX SRL | 56-21420 | V1404314 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 4 YR | Required Intervention |