LONG C/D CLICKER MODEL
Report
- Report Number
- 9680825-2019-00043
- Event Type
- Injury
- Date Received
- July 2, 2019
- Report Date
- July 26, 2019
- Manufacturer
- ORTHOFIX SRL
- Product Code
- JDW
- PMA / PMN Number
- K955848
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- 003
Narratives
THIS EVENT WAS INITIALLY EVALUATED AS A NOT REPORTABLE EVENT. FOLLOWING FURTHER INFORMATION (COPIES OF THE OPERATIVE REPORTS AND X-RAYS) RECEIVED ON JUNE 25, 2019, THE EVENT WAS RE-EVALUATED AND CLASSIFIED AS A REPORTABLE EVENT. ANALYSIS OF HISTORICAL RECORDS ORTHOFIX SRL CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE C/D UNIT CODE 50008 BATCH E59 (LOT LASER MARKED ON THE COMPONENT CODE 500008) 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 SRL HISTORICAL RECORDS, THIS IS THE SECOND NOTIFICATION RECEIVED FROM THIS SPECIFIC DEVICE LOT. ORTHOFIX SRL CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE C/D UNIT CODE 50009 BATCH E98 (LOT LASER MARKED ON THE COMPONENT CODE 500009) BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2018, WAS COMPRISED OF (B)(4) DEVICES. ALL OF THEM HAVE ALREADY BEEN DISTRIBUTED TO THE MARKET. ACCORDING TO ORTHOFIX SRL HISTORICAL RECORDS, NO OTHER NOTIFICATIONS HAVE BEEN RECEIVED FROM THIS SPECIFIC DEVICE LOT. TECHNICAL EVALUATION THE RETURNED DEVICES, RECEIVED ON MAY 23, 2019 WERE EXAMINED BY ORTHOFIX SRL QUALITY ENGINEERING DEPARTMENT. THE DEVICES WERE SUBJECTED TO VISUAL AND DIMENSIONAL CHECK AS PER ORTHOFIX SRL SPECIFICATION. - DEVICE CODE 50008 BATCH E59. THE VISUAL CHECK EVIDENCED AS FOLLOWS: 1). THE COMPONENT CODE 100390 (BACK STOP) IS NO MORE FIXED TO THE COMPONENT CODE 500003 (COMPRESSOR SCREW STD), BECAUSE THE PIN CODE 100391 IS NOW MISSING. 2). THE PIN CODE 951036 IS NOW MISSING FROM THE RETURNED DEVICE. THE DIMENSIONAL CHECK, PERFORMED WHERE POSSIBLE, DID NOT EVIDENCE ANY ANOMALIES. A FUNCTIONAL CHECK WAS NOT PERFORMED AS THE DEVICE IS DAMAGED AND THEREFORE NOT FUNCTIONING. -DEVICE CODE 50009 BATCH E98. THE VISUAL CHECK EVIDENCED THAT THE C/D UNIT PINS ARE CLEARLY BENT AND THE LONG CLICKER BODY IS DAMAGED 1). THE PIN CODE 100361 WAS DAMAGED. THE TIP OF THE PIN WAS BROKEN. 2). THE PIN CODE 500000 WAS BENT. 3). THE THREAD OF COMPRESSOR SCREW LONG CODE 500004 WAS DAMAGED. THE DIMENSIONAL CHECK, PERFORMED WHERE POSSIBLE, DID NOT EVIDENCE ANY ANOMALIES. A FUNCTIONAL CHECK WAS NOT PERFORMED AS THE DEVICE IS DAMAGED AND THEREFORE NOT FUNCTIONING. FROM THE RESULTS OF THE TECHNICAL EVALUATION, IT WAS CONCLUDED THAT: 1). BOTH DEVICES WERE ORIGINALLY CONFORMING TO ORTHOFIX SPECIFICATION. 2). THE DEVICE CODE 50008 EVIDENCED A DAMAGED HEAD WITH A MISSING RETAINING PIN. THESE SIGNS OF DAMAGING INDICATE THAT THIS DEVICE HAS BEEN SUBJECT TO SIGNIFICANT LOAD. 3). THE DEVICE CODE 50009 EVIDENCED THAT AN EXCESSIVE LOAD HAS BEEN APPLIED TO THE MOVING SHANK (CODE 500000) LEADING TO THE DEFORMATION THE PIN. THIS IS CONFIRMED ALSO BY THE DAMAGING OCCURRED ON THE PIN, CODE 100361. FURTHERMORE, THE MAIN THREADS THAT PROVIDE THE COMPRESSION/DISTRACTION ACTION WERE DAMAGED. 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. "THE PATIENT HAD A DEFORMED AND HEALED FEMUR AFTER TREATMENT FOR A GUNSHOT FRACTURE IN SYRIA. AN LRS UNIT WAS APPLIED WITH A DISTAL SWIVELLING CLAMP. THE PLAN WAS TO LENGTHEN INITIALLY AND THEN TO MAKE THE ANGULAR CORRECTION (A GOOD PLAN). THE CD UNIT JAMMED, AND IT WAS NOT POSSIBLE TO CHANGE IT BECAUSE THE PATIENT WAS IN PAIN. ONLY A SHORTER CD UNIT WAS AVAILABLE, SO THEY TOOK THE PATIENT BACK TO THE OPERATING ROOM, AND INTERPOSED A STATIC CLAMP ON THE RAIL TO PROVIDE A BASE FOR THE SHORTER CD UNIT. TEMPORARY LOSS OF POSITION WAS CORRECTED WHEN THE SECOND CD UNIT WAS TIGHTENED. CORRECTION CONTINUED TO COMPLETION AS PLANNED, BUT IT SEEMS THAT THE SECOND CD UNIT ALSO HAS PROBLEMS. THE PATIENT NEEDED TO BE TAKEN BACK TO THE OR.IT SEEMS THAT NO LONG TERM PROBLEMS ARE ANTICIPATED AS THE GOALS OF THE OPERATION WERE ACHIEVED. THE X-RAYS SHOW CLEARLY THAT THE AXIS ALIGNMENT ENDS UP CERTAINLY MUCH IMPROVED AND CLOSE TO IDEAL. I SUSPECT THAT THE SWIVELLING CLAMP WAS USED TO TRY TO OBTAIN ANGULAR CORRECTION AGAINST THE SOFT TISSUE TENSION AFTER LENGTHENING, WHICH WOULD HAVE BEEN VERY SUBSTANTIAL. IT WOULD HAVE BEEN BETTER TO DISTRACT SOME MORE AND THEN TO MAKE THE CORRECTION WHILE ALLOWING SOME SHORTENING TO OCCUR. IT IS POSSIBLE THAT THIS FAILURE, WHICH IS UNUSUAL FOR CD UNITS, HAPPENED BECAUSE OF EXCESS FORCE BEING APPLIED AS A RESULT OF ATTEMPTED ANGULAR CORRECTION WITHOUT SHORTENING. ALSO THE CALLUS IS QUITE WELL DEVELOPED AND MAY HAVE BECOME QUITE STIFF, WHICH AGAIN WOULD HAVE CAUSED DIFFICULTIES FOR CORRECTION. THE SEQUENCE OF PROCEDURES IN THIS CASE ARE QUITE LOGICAL, BUT WERE GOING TO CAUSE PROBLEMS BECAUSE IN THIS CONFIGURATION ANGULAR CORRECTION OF THE SWIVELLING CLAMP CAUSES ADDITIONAL LENGTHENING AT THE OSTEOTOMY WHICH INCREASES TISSUE TENSION. THE PATIENT ENDED UP WITH A GOOD RESULT. THE PRODUCT FAILED BECAUSE OF EXCESS LOAD BEYOND THE DESIGN CRITERIA". FINAL COMMENTS FROM THE RESULTS OF THE TECHNICAL EVALUATION, IT WAS CONCLUDED THAT: 1). BOTH DEVICES WERE ORIGINALLY CONFORMING TO ORTHOFIX SPECIFICATION. 2). THE DEVICE CODE 50008 EVIDENCED A DAMAGED HEAD WITH A MISSING RETAINING PIN. THESE SIGNS OF DAMAGING INDICATE THAT THIS DEVICE HAS BEEN SUBJECT TO SIGNIFICANT LOAD. 3). THE DEVICE CODE 50009 EVIDENCED THAT AN EXCESSIVE LOAD HAS BEEN APPLIED TO THE MOVING SHANK (CODE 500000) LEADING TO THE DEFORMATION THE PIN. THIS IS CONFIRMED ALSO BY THE DAMAGING OCCURRED ON THE PIN, CODE 100361. FURTHERMORE, THE MAIN THREADS THAT PROVIDE THE COMPRESSION/DISTRACTION ACTION WERE DAMAGED. THE MEDICAL EVALUATION EVIDENCED AS FOLLOWS: "THE PATIENT HAD A DEFORMED AND HEALED FEMUR AFTER TREATMENT FOR A GUNSHOT FRACTURE IN SYRIA. AN LRS UNIT WAS APPLIED WITH A DISTAL SWIVELLING CLAMP. THE PLAN WAS TO LENGTHEN INITIALLY AND THEN TO MAKE THE ANGULAR CORRECTION (A GOOD PLAN). THE CD UNIT JAMMED, AND IT WAS NOT POSSIBLE TO CHANGE IT BECAUSE THE PATIENT WAS IN PAIN. ONLY A SHORTER CD UNIT WAS AVAILABLE, SO THEY TOOK THE PATIENT BACK TO THE OPERATING ROOM, AND INTERPOSED A STATIC CLAMP ON THE RAIL TO PROVIDE A BASE FOR THE SHORTER CD UNIT. TEMPORARY LOSS OF POSITION WAS CORRECTED WHEN THE SECOND CD UNIT WAS TIGHTENED. CORRECTION CONTINUED TO COMPLETION AS PLANNED, BUT IT SEEMS THAT THE SECOND CD UNIT ALSO HAS PROBLEMS. THE PATIENT NEEDED TO BE TAKEN BACK TO THE OR. IT SEEMS THAT NO LONG TERM PROBLEMS ARE ANTICIPATED AS THE GOALS OF THE OPERATION WERE ACHIEVED. THE X-RAYS SHOW CLEARLY THAT THE AXIS ALIGNMENT ENDS UP CERTAINLY MUCH IMPROVED AND CLOSE TO IDEAL. I SUSPECT THAT THE SWIVELLING CLAMP WAS USED TO TRY TO OBTAIN ANGULAR CORRECTION AGAINST THE SOFT TISSUE TENSION AFTER LENGTHENING, WHICH WOULD HAVE BEEN VERY SUBSTANTIAL. IT WOULD HAVE BEEN BETTER TO DISTRACT SOME MORE AND THEN TO MAKE THE CORRECTION WHILE ALLOWING SOME SHORTENING TO OCCUR. IT IS POSSIBLE THAT THIS FAILURE, WHICH IS UNUSUAL FOR CD UNITS, HAPPENED BECAUSE OF EXCESS FORCE BEING APPLIED AS A RESULT OF ATTEMPTED ANGULAR CORRECTION WITHOUT SHORTENING. ALSO THE CALLUS IS QUITE WELL DEVELOPED AND MAY HAVE BECOME QUITE STIFF, WHICH AGAIN WOULD HAVE CAUSED DIFFICULTIES FOR CORRECTION. THE SEQUENCE OF PROCEDURES IN THIS CASE ARE QUITE LOGICAL, BUT WERE GOING TO CAUSE PROBLEMS BECAUSE IN THIS CONFIGURATION ANGULAR CORRECTION OF THE SWIVELLING CLAMP CAUSES ADDITIONAL LENGTHENING AT THE OSTEOTOMY WHICH INCREASES TISSUE TENSION. THE PATIENT ENDED UP WITH A GOOD RESULT. THE PRODUCT FAILED BECAUSE OF EXCESS LOAD BEYOND THE DESIGN CRITERIA". BASED ON THE RESULTS OF THE TECHNICAL EVALUATION AND ON THE EVIDENCES DERIVING FROM THE MEDICAL EVALUATION, ORTHOFIX SRL CAN CONCLUDE THAT THE PROBLEM THAT OCCURRED IS DUE TO EXCESSIVE LOAD APPLIED IN THIS SPECIFIC APPLICATION. ORTHOFIX SRL CONTINUES MONITORING THE DEVICES ON THE MARKET. PLEASE ALSO KINDLY REFER TO MFR REPORT 9680825-2019-00042.
THE INFORMATION INITIALLY PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: - DEVICES CODE: 50008 (STANDARD C/D CLICKER MODEL) & 50009 (LONG C/D CLICKER MODEL) - MFR REPORTS 9680825-2019-00042 & 9680825-2019-00043 RESPECTIVELY; - BATCH NUMBER: E59 & E98; - QUANTITY: 1 EACH; - HOSPITAL NAME: (B)(6); - SURGEON NAME: DR (B)(6); - DATE OF INITIAL SURGERY: NO RESPONSE; - BODY PART TO WHICH DEVICE WAS APPLIED: NO RESPONSE; - SURGERY DESCRIPTION: NO RESPONSE; - PATIENT INFORMATION: NO RESPONSE; - PROBLEM OBSERVED DURING: INTO TREATMENT/POST-OPERATIVE; - TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM; - EVENT DESCRIPTION: "BEIDE GEWINDE SIND NACH DER VERLÄNGERUNG NICHT MEHR GANGBAR. AN EINEM DISTRAKTOR IST EIN STIFT VERBOGEN UND AM ANDEREN STIFT DER GEWINDETEIL ABGEBROCHEN. KUNDE REKLAMIERT MATERIALFEHLER". BOTH THREADS ARE NOT WORKING AFTER THE EXTENSION. ON ONE DISTRACTOR ONE PIN IS BENT AND THE THREADED PART OF THE OTHER PIN IS BROKEN OFF. CUSTOMER COMPLAINS ABOUT MATERIAL DEFECTS. THE COMPLAINT REPORT FORM ALSO INDICATED: - THE DEVICE FAILURE DID NOT HAVE ANY ADVERSE EFFECTS ON PATIENT; - THE INITIAL SURGERY WAS COMPLETED WITH THE DEVICE; - THE EVENT DID NOT LEAD TO A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE SURGICAL PROCEDURE; - AN ADDITIONAL SURGERY WAS NOT REQUIRED; - A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED; - AVAILABILITY OF COPIES OF THE OPERATIVE REPORTS: NO RESPONSE; - AVAILABILITY OF COPIES OF THE X-RAY IMAGES: NO RESPONSE; - PATIENT CURRENT HEALTH CONDITION: NO RESPONSE. ON JUNE 13, 2019, ORTHOFIX SRL RECEIVED THE FOLLOWING ADDITIONAL INFORMATION FROM THE LOCAL DISTRIBUTOR: - DATE OF THE INITIAL SURGERY:(B)(6) 2018; - NAME OF THE SURGEONS: DR. (B)(6), DR. (B)(6), AND DR. (B)(6); - SITE OF APPLICATION: RIGHT FEMUR; - TYPE OF SURGERY: MALUNION MANAGEMENT (18° VARUS AND 3 CM SHORTENING); - PATIENT INFORMATION: 28 YEARS, MALE, ABOUT 70 KG, ABOUT 175 CM; - THE C/D UNITS MALFUNCTIONED AT THE SAME TIME; - THE TREATMENT WAS COMPLETED WITH THESE DEVICES; - THE PATIENT IS IN GOOD HEALTH CONDITIONS. NO ADVERSE EFFECTS ON PATIENT. ON JUNE 25, 2019, ORTHOFIX SRL RECEIVED COPIES OF THE OPERATIVE REPORTS AND COPIES OF THE X-RAY IMAGES. MANUFACTURER REF: (B)(4). DISTRIBUTOR REF: (B)(4).
THIS EVENT WAS INITIALLY EVALUATED AS A NOT REPORTABLE EVENT. FOLLOWING FURTHER INFORMATION (COPIES OF THE OPERATIVE REPORTS AND X-RAYS) RECEIVED ON JUNE 25, 2019, THE EVENT WAS RE-EVALUATED AND CLASSIFIED AS A REPORTABLE EVENT. ANALYSIS OF HISTORICAL RECORDS. ORTHOFIX (B)(4) CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE C/D UNIT CODE 50008 BATCH E59 (LOT LASER MARKED ON THE COMPONENT CODE 500008) 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 SECOND NOTIFICATION RECEIVED FROM THIS SPECIFIC DEVICE LOT. ORTHOFIX (B)(4) CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE C/D UNIT CODE 50009 BATCH E98 (LOT LASER MARKED ON THE COMPONENT CODE 500009) BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2018, 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 FROM THIS SPECIFIC DEVICE LOT. TECHNICAL EVALUATION: THE TECHNICAL EVALUATION ON THE RETURNED DEVICES, RETURNED ON MAY 23, 2019, 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 WILL BE AVAILABLE. AS SOON AS THE RESULTS OF THE INVESTIGATION ARE 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 REPORT 9680825-2019-00042. (B)(4).
THE INFORMATION INITIALLY PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: DEVICES CODE: 50008 (STANDARD C/D CLICKER MODEL) & 50009 (LONG C/D CLICKER MODEL). BATCH NUMBER: E59 & E98. QUANTITY: 1 EACH. HOSPITAL NAME: (B)(6). SURGEON NAME: DR (B)(6). DATE OF INITIAL SURGERY: NO RESPONSE. BODY PART TO WHICH DEVICE WAS APPLIED: NO RESPONSE. SURGERY DESCRIPTION: NO RESPONSE. PATIENT INFORMATION: NO RESPONSE. PROBLEM OBSERVED DURING: INTO TREATMENT/POST-OPERATIVE. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: BOTH THREADS ARE NOT WORKING AFTER THE EXTENSION. ON ONE DISTRACTOR ONE PIN IS BENT AND THE THREADED PART OF THE OTHER PIN IS BROKEN OFF. CUSTOMER COMPLAINS ABOUT MATERIAL DEFECTS. THE COMPLAINT REPORT FORM ALSO INDICATED: THE DEVICE FAILURE DID NOT HAVE ANY ADVERSE EFFECTS ON PATIENT. THE INITIAL SURGERY WAS COMPLETED WITH THE DEVICE. THE EVENT DID NOT LEAD TO A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE SURGICAL PROCEDURE. AN ADDITIONAL SURGERY WAS NOT REQUIRED. A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED. AVAILABILITY OF COPIES OF THE OPERATIVE REPORTS: NO RESPONSE. AVAILABILITY OF COPIES OF THE X-RAY IMAGES: NO RESPONSE. PATIENT CURRENT HEALTH CONDITION: NO RESPONSE. ON JUNE 13, 2019, ORTHOFIX (B)(4) RECEIVED THE FOLLOWING ADDITIONAL INFORMATION FROM THE LOCAL DISTRIBUTOR: DATE OF THE INITIAL SURGERY: (B)(6) 2018. NAME OF THE SURGEONS: DR. (B)(6). SITE OF APPLICATION: RIGHT FEMUR. TYPE OF SURGERY: MALUNION MANAGEMENT (18° VARUS AND 3 CM SHORTENING). PATIENT INFORMATION: (B)(6) YEARS, MALE, ABOUT (B)(6). THE C/D UNITS MALFUNCTIONED AT THE SAME TIME. THE TREATMENT WAS COMPLETED WITH THESE DEVICES. THE PATIENT IS IN GOOD HEALTH CONDITIONS. NO ADVERSE EFFECTS ON PATIENT. ON JUNE 25, 2019, ORTHOFIX (B)(4) RECEIVED COPIES OF THE OPERATIVE REPORTS AND COPIES OF THE X-RAY IMAGES. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 548604 | LONG C/D CLICKER MODEL | LONG C/D CLICKER MODEL | JDW | ORTHOFIX SRL | 50009 | E98 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 28 YR | Required Intervention |