TL+ METAL DISTRACTION / COMPRESSION NUT
Report
- Report Number
- 9680825-2019-00050
- Event Type
- Injury
- Date Received
- August 8, 2019
- Date of Event
- July 8, 2019
- Report Date
- October 1, 2019
- Manufacturer
- ORTHOFIX SRL
- Product Code
- LXT
- PMA / PMN Number
- K941048
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
ANALYSIS OF HISTORICAL RECORDS. ORTHOFIX SRL CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE DEVICE CODE 50-13010 LOT 26943244 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT WAS COMPRISED OF (B)(4) UNITS, MANUFACTURED IN OCTOBER 2018 (B)(4)UNITS) AND NOVEMBER 2018 (B)(4)UNITS). ALL OF THEM HAVE ALREADY BEEN DISTRIBUTED TO THE MARKET. ACCORDING TO ORTHOFIX SRL HISTORICAL RECORDS, NO OTHER NOTIFICATIONS HAVE BEEN RECEIVED IN REGARDS TO THIS SPECIFIC DEVICE LOT. ORTHOFIX SRL CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE DEVICE CODE 50-13010 LOT 27421814 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT WAS COMPRISED OF 486 UNITS, MANUFACTURED IN NOVEMBER 2018 (B)(4) UNITS), DECEMBER 2018 (B)(4) UNITS) AND FEBRUARY 2019 (B)(4) UNITS). ALL OF THEM HAVE ALREADY BEEN DISTRIBUTED TO THE MARKET. ACCORDING TO ORTHOFIX SRL HISTORICAL RECORDS, NO OTHER NOTIFICATIONS HAVE BEEN RECEIVED IN REGARDS TO THIS SPECIFIC DEVICE LOT. TECHNICAL EVALUATION ON (B)(6) 2019 ORTHOFIX SRL RECEIVED BACK FROM THE LOCAL DISTRIBUTOR THE FOLLOWING DEVICES: 3 TL+ METAL DISTRACTION / COMPRESSION NUT CODE 50-13010, 2 TL, NUT, STAINLESS STEEL, 10MM CODE 50-1008, 1 TL+ THREADED HEX END ROD 300MM CODE 55-11740 AND 1 TL+ THREADED HEX END ROD 400MM CODE 55-11750. ALTHOUGH ONLY THE CODE 50-13010 WAS COMPLAINED, ALL OF THEM WERE EXAMINED BY ORTHOFIX SRL QUALITY ENGINEERING AREA. THE DEVICES WERE SUBJECTED TO VISUAL AND FUNCTIONAL CHECK AS PER ORTHOFIX SRL DESIGN AND PRODUCT SPECIFICATIONS. THE VISUAL EXAMINATION CONFIRMED THAT ALL THREADED RODS ARE BROKEN AND THE PROFILE OF THE M6 THREAD IS DAMAGED IN DIFFERENT POSITIONS. THE NUTS CODE 50-13010 ARE JAMMED. THE DIMENSIONAL CHECK OF THE THREADED RODS DID NOT SHOW ANY ANOMALIES. IT WAS NOT POSSIBLE TO PERFORM THE DIMENSIONAL CHECK OF THE NUTS AS THEY ARE DAMAGED. THE FUNCTIONAL CHECK OF THE THREADED RODS DID NOT SHOW ANY ANOMALIES. THEY STILL PERFORM PROPERLY. IT WAS NOT POSSIBLE TO PERFORM THE FUNCTIONAL CHECK OF THE NUTS AS THEY ARE DAMAGED. THE FUNCTIONAL CHECK OF THE STAINLESS STEEL NUTS, CODE 50-1008 DID NOT SHOW ANY ANOMALIES. THEY STILL PERFORM PROPERLY. MEDICAL EVALUATION: THE INFORMATION MADE AVAILABLE ON THE CASE WITH THE RESULTS OF THE TECHNICAL ANALYSIS WAS SENT TO OUR MEDICAL EVALUATOR. PLEASE FIND BELOW AN EXTRACT OF THE MEDICAL EVALUATION PERFORMED. -(B)(6) 2019 IT SEEMS THAT SOMETHING MECHANICAL WENT WRONG DURING THIS OPERATION TO LENGTHEN A TIBIA, BUT FROM THE INFORMATION RECEIVED IT IS NOT AT ALL CLEAR WHAT THE PROBLEM WAS. THE REPORT SUGGESTS THAT THERE WAS AN ATTEMPT TO TURN SOME NUTS AGAINST A FIRM MECHANICAL BLOCK, AND THIS SUGGESTS TO ME THAT THE WRONG NUTS WERE BEING TURNED. HOWEVER THIS IS GUESSWORK. -(B)(6) WITH THE OUTCOME OF THE TECHNICAL ANALYSIS. THE TECHNICAL ANALYSIS RELATING TO THIS EVENT SHOWS CLEARLY THAT THE NUTS RETURNED WERE FULLY TO SPECIFICATION. I CAN UNDERSTAND THE SURGEON'S FRUSTRATION. LIKE YOU I CANNOT UNDERSTAND EXACTLY WHAT WENT WRONG. WE NEED TO HAVE A PHOTOGRAPH OF THE FRAME THAT WAS USED TO UNDERSTAND THIS. I CANNOT UNDERSTAND WHY THE LENGTHENING NUTS SEEMED TO BE LOCKED; IT MUST RELATE TO THE WAY THAT THE FRAME WAS ASSEMBLED, BUT WITHOUT MORE INFORMATION WE CANNOT MAKE A SENSIBLE COMMENT. SOMEHOW THE THREADED RODS ALL BECAME DAMAGED ENOUGH TO INTERFERE WITH THE PROGRESSION OF THE NUTS, BUT AGAIN HAVE NOT BEEN TOLD HOW THIS MIGHT HAVE HAPPENED. WITHOUT MORE INFORMATION WE CANNOT ANSWER THE SURGEONS QUESTIONS, AND WITHOUT ANSWERS THE SURGEON WILL CONTINUE TO BE UNHAPPY. THE DISTRIBUTOR NEEDS TO UNDERSTAND THIS AND EXPLAIN TO THE SURGEON THAT WE CANNOT GIVE A SENSIBLE EXPLANATION OF WHY THIS EVENT OCCURRED WITHOUT BASIC INFORMATION ABOUT HOW THE NUTS WERE BEING USED. FINAL COMMENTS: THE RESULTS OF THE TECHNICAL EVALUATION CONCLUDED THAT THE RETURNED DEVICES WERE ORIGINALLY CONFORMING TO ORTHOFIX DESIGN SPECIFICATIONS. FROM THE EVIDENCES COLLECTED DURING THE VISUAL AND THE FUNCTIONAL VERIFICATIONS, IT IS POSSIBLE TO ASSUME THAT THE NUTS JAMMED ON THE THREADED RODS DUE TO APPLICATION RELATED ISSUES. IT IS NOT POSSIBLE TO DETERMINE IF THE PROFILE OF THE M6 THREADED RODS WAS DAMAGED DURING THE SURGERY OR REPROCESSING OR IF IT IS DUE TO THE ATTEMPT TO REMOVE THE NUTS FROM THE THREADED RODS. ORTHOFIX SRL HISTORICAL RECORDS SHOWS THAT NO OTHER NOTIFICATIONS HAVE BEEN RECEIVED IN REGARDS TO THESE SPECIFIC DEVICE LOTS. ORTHOFIX SRL CONTINUES MONITORING THE DEVICES ON THE MARKET. PLEASE KINDLY REFER ALSO TO MFR REPORT NUMBER 9680825-2019-00049 FOLLOW UP 1 AND MFR REPORT NUMBER 9680825-2019-00051 FOLLOW UP 1 - ATTACHMENT: [2019135_FDA MEDWATCH COVER LETTER FOLLOW UP 1.PDF].
THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6)HOSPITAL. SURGEON NAME: (B)(6). DATE OF INITIAL SURGERY:(B)(6) 2019. BODY PART TO WHICH DEVICE WAS APPLIED: TIBIA. SURGERY DESCRIPTION: SPECIFIED IN EVENT DESCRIPTION. PATIENT INFORMATION: 50 YEAR-OLD, MALE, WEIGHT 80 KG, HEIGHT 1.75 METERS, PREVIOUS HEALTH CONDITION: TIBIA BONE LOSS. PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM EVENT DESCRIPTION PROVIDED IN SPANISH: AL PACIENTE SE LE IBA A REALIZAR UN TRANSPORTE OSEO EN TIBIA. SE REALIZÓ TODO EL PROCEDIMIENTO Y EL MONTAJE DEL TRUELOCK. TERMINANDO LA CIRUGÍA, EL DOCTOR (B)(6) DISTRAER LA OSTEOTOMIA Y REALIZAMOS CON LA LLAVE DOBLE LA DISTRACCIÓN (COMO SI FUERA UN ALARGAMIENTO) EN ESE MOMENTO 3 TUERCAS DE ALARGAMIENTO SE CONSOLIDARON A LAS BARRAS. INTENTAMOS CON TODAS LAS LLAVES DE 10 GIRARLAS, FUE IMPOSIBLE. NOS TOCÓ CORTAR LAS BARRAS Y CAMBIAR TODO EL MONTAJE (QUE YA ESTABA UBICADO EN EL PACIENTE) LO QUE GENERÓ LA TRASLACIÓN DE LA OSTEOTOMIA. SE ORGANIZÓ NUEVAMENTE EL MONTAJE CON TUERCAS NUEVAS Y BARRAS NUEVAS Y SE INTENTÓ CORREGIR LA TRASLACIÓN (NO QUEDÓ COMO EL DR (B)(6). EVENT DESCRIPTION PROVIDED IN ENGLISH: "LAST MONDAY, (B)(6), AT THE (B)(6) HOSPITAL, A LENGTHENING SURGERY FOR THE TIBIA WAS PERFORMED, WITH DR. (B)(6) AND MY PERSON AS TECHNICAL SUPPORT. DURING THE WHOLE PROCEDURE WE DID VERY WELL, THE ASSEMBLY AND APPLICATION OF THE TUTOR WERE GOOD. AT THE MOMENT THAT THE DR WANTS TO DISTRACT THE OSTEOTOMY, TURNING THE LENGTHENING NUTS, FOUR OF THEM ARE FULLY CONSOLIDATED TO THE BARS, BLOCKING THE WHOLE SYSTEM. TO SOLVE WE HAD TO CUT THE BARS AND CHANGE THE WHOLE PART OF THE ASSEMBLY THAT WAS AFFECTED; THEREFORE THE OSTEOTOMY MOVED. FINALLY AND IN SUMMARY, WE FINISHED THE PROCEDURE AFTER CORRECTING THE WHOLE PROBLEM (THE TRANSLATION COULD NOT BE COMPLETELY CORRECTED). WE ARE WAITING FOR THE REVIEW OF SAID PATIENT (B)(6)2019) WHERE HE WILL VERIFY THE FUNCTIONING OF THE TUTOR AND THE POST-OPERATIVE LENGTHENING NUTS. THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE CAUSED ADVERSE EFFECTS ON PATIENT (LOSS OF FRACTURE REDUCTION) THE INITIAL SURGERY WAS NOT COMPLETED WITH THE DEVICE A REPLACEMENT DEVICE WAS IMMEDIATELY AVAILABLE TO COMPLETE SURGERY THE EVENT LED TO A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE SURGICAL PROCEDURE: WE HAD TO DELAY THE THEATRE PROGRAM, I.E. THE FOLLOWING SURGERIES AN ADDITIONAL SURGERY WAS NOT REQUIRED. A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED. COPIES OF THE OPERATIVE REPORTS ARE NOT AVAILABLE. COPIES OF THE X-RAY IMAGES ARE NOT AVAILABLE. PATIENT CURRENT HEALTH CONDITION: THE PATIENT HAS A FOLLOW UP MEETING WITH THE DOCTOR ON (B)(6) 2019. THE DOCTOR WILL KEEP US INFORMED. MANUFACTURER REFERENCE NUMBER: (B)(4).
ANALYSIS OF HISTORICAL RECORDS: THE DEVICES INVOLVED IN THIS EVENT HAVE NOT BEEN RETURNED TO ORTHOFIX (B)(4) YET. THE DEVICES LOT NUMBER HAS NOT BEEN SPECIFIED YET. THEREFORE IT IS NOT POSSIBLE TO PERFORM THE VERIFICATION OF THE HISTORICAL DATA. TECHNICAL EVALUATION: THE DEVICES INVOLVED IN THIS EVENT HAVE NOT BEEN RETURNED TO ORTHOFIX (B)(4) YET. THE TECHNICAL EVALUATION WILL BE PERFORMED AS SOON AS THE DEVICES ARE RECEIVED. 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 ARE AVAILABLE. AS SOON AS THE RESULTS OF THE TECHNICAL INVESTIGATION BECOME AVAILABLE, ORTHOFIX (B)(4) WILL PROVIDE YOU WITH A FOLLOW UP REPORT. ORTHOFIX (B)(4) CONTINUES MONITORING THE DEVICES ON THE MARKET. PLEASE KINDLY REFER ALSO TO MFR REPORT NUMBER 9680825-2019-00049 AND MFR REPORT NUMBER 9680825-2019-00051. (B)(4).
THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6) HOSPITAL, SURGEON NAME: DR (B)(6), DATE OF INITIAL SURGERY: (B)(6) 2019, BODY PART TO WHICH DEVICE WAS APPLIED: TIBIA, SURGERY DESCRIPTION: SPECIFIED IN EVENT DESCRIPTION, PATIENT INFORMATION: (B)(6) YEAR-OLD, MALE, WEIGHT (B)(6), HEIGHT 1.75 METERS, PREVIOUS HEALTH CONDITION: TIBIA BONE LOSS, PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE, TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: "LAST (B)(6), AT THE (B)(6) HOSPITAL, A LENGTHENING SURGERY FOR THE TIBIA WAS PERFORMED, WITH DR. (B)(6) AND MY PERSON AS TECHNICAL SUPPORT. DURING THE WHOLE PROCEDURE WE DID VERY WELL, THE ASSEMBLY AND APPLICATION OF THE TUTOR WERE GOOD. AT THE MOMENT THAT THE DR WANTS TO DISTRACT THE OSTEOTOMY, TURNING THE LENGTHENING NUTS, FOUR OF THEM ARE FULLY CONSOLIDATED TO THE BARS, BLOCKING THE WHOLE SYSTEM. TO SOLVE WE HAD TO CUT THE BARS AND CHANGE THE WHOLE PART OF THE ASSEMBLY THAT WAS AFFECTED; THEREFORE THE OSTEOTOMY MOVED. FINALLY AND IN SUMMARY, WE FINISHED THE PROCEDURE AFTER CORRECTING THE WHOLE PROBLEM (THE TRANSLATION COULD NOT BE COMPLETELY CORRECTED). WE ARE WAITING FOR THE REVIEW OF SAID PATIENT ((B)(6) 2019) WHERE HE WILL VERIFY THE FUNCTIONING OF THE TUTOR AND THE POST-OPERATIVE LENGTHENING NUTS. THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE CAUSED ADVERSE EFFECTS ON PATIENT (LOSS OF FRACTURE REDUCTION). THE INITIAL SURGERY WAS NOT COMPLETED WITH THE DEVICE. A REPLACEMENT DEVICE WAS IMMEDIATELY AVAILABLE TO COMPLETE SURGERY. THE EVENT LED TO A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE SURGICAL PROCEDURE: WE HAD TO DELAY THE THEATRE PROGRAM, I.E. THE FOLLOWING SURGERIES. AN ADDITIONAL SURGERY WAS NOT REQUIRED. A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED. COPIES OF THE OPERATIVE REPORTS ARE NOT AVAILABLE. COPIES OF THE X-RAY IMAGES ARE NOT AVAILABLE. PATIENT CURRENT HEALTH CONDITION: THE PATIENT HAS A FOLLOW UP MEETING WITH THE DOCTOR ON (B)(6) 2019. THE DOCTOR WILL KEEP US INFORMED. MANUFACTURER REFERENCE NUMBER: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 667112 | TL+ METAL DISTRACTION / COMPRESSION NUT | TL+ METAL DISTRACTION / COMPRESSION NUT | LXT | ORTHOFIX SRL | 50-13010 | 26943244 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Required Intervention |