COMPRESSION DISTRACTION UNIT LONG
Report
- Report Number
- 9680825-2019-00079
- Event Type
- Injury
- Date Received
- December 2, 2019
- Report Date
- February 24, 2020
- Manufacturer
- ORTHOFIX SRL
- Product Code
- JDW
- PMA / PMN Number
- K955848
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- 003
Narratives
ANALYSIS OF HISTORICAL RECORDS: ORTHOFIX SRL CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE COMPONENT CODE 10008 LOT E142 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2017, WAS COMPRISED OF (B)(4) DEVICES. ACCORDING TO ORTHOFIX SRL HISTORICAL RECORDS, NO OTHER NOTIFICATIONS HAVE BEEN RECEIVED IN REGARDS TO THIS SPECIFIC DEVICE LOT. (MFR REPORT 9680825-2019-00078). ORTHOFIX SRL CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE COMPONENT CODE 10009 LOT E168 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2016, WAS COMPRISED OF (B)(4) DEVICES. ACCORDING TO ORTHOFIX SRL HISTORICAL RECORDS, NO OTHER NOTIFICATIONS HAVE BEEN RECEIVED IN REGARDS TO THIS SPECIFIC DEVICE LOT. (MFR REPORT 9680825-2019-00079). ORTHOFIX SRL CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE COMPONENT CODE 10009 LOT E182 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2018, WAS COMPRISED OF (B)(4) DEVICES. ACCORDING TO ORTHOFIX SRL HISTORICAL RECORDS, NO OTHER NOTIFICATIONS HAVE BEEN RECEIVED IN REGARDS TO THIS SPECIFIC DEVICE LOT. (MFR REPORT 9680825-2019-00080). ORTHOFIX SRL CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE COMPONENT CODE 10009 LOT E183 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2018 WAS COMPRISED OF (B)(4) DEVICES. ACCORDING TO ORTHOFIX SRL HISTORICAL RECORDS, NO OTHER NOTIFICATIONS HAVE BEEN RECEIVED IN REGARDS TO THIS SPECIFIC DEVICE LOT. (MFR REPORT 9680825-2019-00081). TECHNICAL EVALUATION: THE RETURNED DEVICES, RECEIVED IN CONTAMINATED CONDITIONS ON JANUARY 14, 2020, WERE IMMEDIATELY SENT TO AN EXTERNAL LABORATORY FOR DECONTAMINATION AND STERILIZATION ACTIVITIES. AT THE END OF THE DECONTAMINATION AND STERILIZATION ACTIVITIES, THE DEVICES WERE IMMEDIATELY EXAMINED BY ORTHOFIX SRL QUALITY ENGINEERING DEPARTMENT. ALL THE DEVICES WERE SUBJECTED TO VISUAL CHECK. IT WAS NOTED PRESENCE OF RUST/RESIDUALS AND THE ELASTIC PIN ON ALL DEVICES IS MISSING. A FUNCTIONAL CHECK WAS NOT POSSIBLE AS THE DEVICES ARE NOT FUNCTIONING DUE TO THE LOSS OF THE ELASTIC PINS. MEDICAL EVALUATION: THE LITTLE INFORMATION MADE AVAILABLE ON THE EVENT AND THE RESULTS OF THE TECHNICAL EVALUATION WERE SENT TO OUR MEDICAL EVALUATOR. PLEASE FIND BELOW AN EXTRACT OF THE MEDICAL EVALUATION PERFORMED. NOVEMBER 20, 2019: "FROM THE REPORT, ALL THE INFORMATION THAT WE HAVE IN THIS CASE IS THAT 4 COMPRESSION/DISTRACTION UNITS MALFUNCTIONED. THE OPERATING TIME WAS PROLONGED BY AN UNSPECIFIED AMOUNT. WE HAVE NO MORE INFORMATION". FEBRUARY 17, 2020 WITH THE RESULTS OF THE TECHNICAL EVALUATION: "THE TECHNICAL REPORT ON THESE 4 COMPRESSION/DISTRACTION UNITS SHOWS THAT THEY HAVE BEEN VERY POORLY PROCESSED BECAUSE OF THE RUST MARKS VISIBLE. HOWEVER THE MOST IMPORTANT FEATURE OF EACH UNIT IS THAT THE ELASTIC PINS THAT LOCK THE HEXAGONAL SOCKET TO THE THREADED PART IS MISSING. THEREFORE IN EACH CASE TURNING THE HEXAGONAL NUT WILL NOT CAUSE THE COMPRESSION/DISTRACTION UNIT TO LENGTHEN OR SHORTEN, AND THE UNITS ARE THEREFORE USELESS. WE KNOW FROM THE RECORDS THAT THE UNITS WERE ALL FULLY TO SPECIFICATION WHEN SUPPLIED, AND THEY ARE ALL FROM DIFFERENT BATCHES. THEREFORE THE ONLY CONCLUSION MUST BE THAT THESE DEVICES ARE BEING TREATED IN SUCH A WAY AS TO CAUSE THEM TO BECOME RUSTY, AND LOSE THE ELASTIC LOCKING PINS WHICH ARE MISSING. THESE DEVICES FAILED BECAUSE OF INCORRECT HANDLING OR PROCESSING. ALSO, AS PREVIOUSLY COMMENTED, THE INFORMATION SUPPLIED WITH THIS COMPLAINT IS SO VAGUE AND INCOMPLETE THAT NO CONCLUSION CAN BE DRAWN. I DO NOT THINK THAT THIS CAUSED A SERIOUS INJURY, BECAUSE: THE INFORMATION PROVIDED IS INCOMPLETE AND INCONSISTENT. I THINK THAT IT IS LIKELY THAT THE FAILURE OCCURRED INTRAOPERATIVELY, WHEN THE SURGEON REALISED THAT THE DEVICES WERE NON FUNCTIONAL. THERE MIGHT HAVE BEEN SOME DELAY WHILE A FUNCTIONING COMPRESSION/DISTRACTION UNIT WAS FOUND. THESE DEVICES SHOULD NEVER HAVE BEEN RE-STERILISED BECAUSE THEY ARE NON FUNCTIONAL. WE ARE TOLD THAT THE PATIENT HAS LEFT HOSPITAL, CONDITION UNKNOWN. THE SITUATION AROSE BECAUSE OF FAILURE OF CORRECT HOSPITAL PROCEDURES. THESE DEVICES SHOULD NEVER HAVE BEEN USED. FINAL COMMENTS: THE RESULTS OF THE TECHNICAL EVALUATION CONCLUDED THAT THE RETURNED DEVICES WERE ORIGINALLY CONFORMING TO SPECIFICATIONS. A COMPLETE MEDICAL EVALUATION OF THE EVENT WAS NOT POSSIBLE AS NO INFORMATION ABOUT THE MEDICAL PROCEDURE, DIAGNOSIS AND X-RAYS HAVE BEEN MADE AVAILABLE. IN REGARDS TO THIS EVENT ORTHOFIX SRL RECEIVED DISCORDANT DATA. TO CLARIFY THE EVENT, ORTHOFIX SRL REQUESTED SHANGHAI CIIC TO PROVIDE FURTHER INFORMATION SUCH AS: BODY PART TO WHICH DEVICE WAS APPLIED. WHEN THE PROBLEM WAS OBSERVED (DURING SURGERY OR INTO TREATMENT). INFORMATION ABOUT THE FUNCTIONAL PROBLEM HAD WITH THE COMPRESSION/DISTRACTION UNITS. PATIENT'S DIAGNOSIS, PLANNED TREATMENT, AND CODE OF THE EXTERNAL FIXATOR USED. DID THE FOUR COMPRESSION/DISTRACTION UNITS FAIL AT THE SAME TIME OR IN DIFFERENT STAGES OF THE TREATMENT? ESTIMATION OF THE DELAY OCCURRED DURING SURGERY. CONFIRMATION THAT THE INFORMATION "INCREASE THE TIMES OF INTRAOPERATIVE FLUOROSCOPY AND INTRAOPERATIVE REDUCTION TIME" INCLUDED IN THE COMPLAINT FORM IS RELEVANT TO THIS EVENT. DATE AND OUTCOME OF THE ADDITIONAL INTERVENTION. COPY OF X-RAY IMAGES. CONFIRMATION THAT THE PATIENT IS WELL UNFORTUNATELY, THIS INFORMATION WAS NOT MADE AVAILABLE. CONSIDERING THE LITTLE AND DISCORDANT INFORMATION PROVIDED, IT WAS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE EVENT OCCURRED. ORTHOFIX SRL HISTORICAL RECORDS SHOWS THAT NO OTHER NOTIFICATIONS HAVE BEEN RECEIVED IN REGARDS TO THESE SPECIFIC DEVICE LOTS. SHOULD FURTHER INFORMATION BECOME AVAILABLE, ORTHOFIX SRL WILL FINALIZE THE INVESTIGATION. ORTHOFIX SRL CONTINUES MONITORING THE DEVICES ON THE MARKET. PLEASE ALSO KINDLY REFER TO MFR REPORTS 9680825-2019-00078 AND 9680825-2019-00080 AND 9680825-2019-00081.
THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: DEVICES CODE: 10008 (COMPRESSION DISTRACTION UNIT STANDARD) & 10009 (COMPRESSION DISTRACTION UNIT LONG). BATCH NUMBER: ONE UNIT OF CODE 10008 LOT E142 AND THREE UNITS OF CODE 10009 LOTS E168, E182 AND E183. QUANTITY: ONE UNIT OF CODE 10008 AND THREE UNITS OF CODE 10009 (MFR REPORTS 9680825-2019-00078 AND 9680825-2019-00079 AND 9680825-2019-00080 AND 9680825-2019-00081). HOSPITAL NAME: (B)(6) HOSPITAL. SURGEON NAME: (B)(6). DATE OF INITIAL SURGERY: (B)(6) 2019. BODY PART TO WHICH DEVICE WAS APPLIED: NO RESPONSE RECEIVED. SURGERY DESCRIPTION: CORRECTION. PATIENT INFORMATION: 17 YEARS, MALE, 74 KG, 170 CM, GOOD HEALTH CONDITIONS. PROBLEM OBSERVED DURING: HOSPITAL PRE-USE INSPECTION. TYPE OF PROBLEM: OTHER, SEE EVENT DESCRIPTION. EVENT DESCRIPTION: "LOOSENING CLAMP FOUND DURING OPERATION". THE COMPLAINT REPORT FORM ALSO INDICATED: THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT (LOSS OF FRACTURE REDUCTION, LOSS OF ACHIEVED CORRECTION). THE INITIAL SURGERY WAS COMPLETED WITH THE DEVICE. THE EVENT LED TO A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE SURGICAL PROCEDURE (INCREASE THE TIMES OF INTRAOPERATIVE FLUOROSCOPY AND INTRAOPERATIVE REDUCTION TIME). AN ADDITIONAL SURGERY WAS 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. PRODUCT NOT AVAILABLE FOR RETURN. PATIENT CURRENT HEALTH CONDITION: "AT THE CURRENT STAGE, THE PATIENT HAS BEEN LEAVE HOSPITAL." NO OTHER INFORMATION WAS PROVIDED. MANUFACTURER REF: (B)(4).
ANALYSIS OF HISTORICAL RECORDS: THE DEVICES INVOLVED IN THIS EVENT HAVE NOT YET BEEN RECEIVED BY ORTHOFIX (B)(4). UNFORTUNATELY ALSO THE LOT NUMBERS HAVE NOT BEEN MADE AVAILABLE AND THEREFORE IT WAS NOT POSSIBLE TO PERFORM THE VERIFICATION OF THE HISTORICAL DATA. TECHNICAL EVALUATION: THE DEVICES INVOLVED IN THIS EVENT HAVE NOT YET BEEN RECEIVED BY ORTHOFIX (B)(4). ORTHOFIX (B)(4) IS STRICTLY IN CONTACT WITH THE LOCAL DISTRIBUTOR TO HAVE THE DEVICES CONCERNED. THE TECHNICAL EVALUATION WILL BE PERFORMED AS SOON AS THE DEVICES BECOME AVAILABLE. 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 FURTHER INFORMATION/CLARIFICATION AND/OR THE RESULTS OF THE TECHNICAL EVALUATION BECOME AVAILABLE. IN REGARDS TO THIS EVENT ORTHOFIX (B)(4) RECEIVED DISCORDANT DATA. TO CLARIFY THE EVENT, ORTHOFIX (B)(4) REQUESTED THE LOCAL DISTRIBUTOR TO PROVIDE FURTHER INFORMATION SUCH AS: BATCH NUMBER OF THE AFFECTED DEVICES. BODY PART TO WHICH DEVICE WAS APPLIED. WHEN THE PROBLEM WAS OBSERVED (DURING SURGERY OR INTO TREATMENT). INFORMATION ABOUT THE FUNCTIONAL PROBLEM HAD WITH THE COMPRESSION/DISTRACTION UNITS. PATIENT'S DIAGNOSIS, PLANNED TREATMENT, AND CODE OF THE EXTERNAL FIXATOR USED. DID THE FOUR COMPRESSION/DISTRACTION UNITS FAIL AT THE SAME TIME OR IN DIFFERENT STAGES OF THE TREATMENT? ESTIMATION OF THE DELAY OCCURRED DURING SURGERY. CONFIRMATION THAT THE INFORMATION "INCREASE THE TIMES OF INTRAOPERATIVE FLUOROSCOPY AND INTRAOPERATIVE REDUCTION TIME" IS RELEVANT TO THIS EVENT. DATE AND OUTCOME OF THE ADDITIONAL INTERVENTION. COPY OF X-RAY IMAGES. CONFIRMATION THAT THE PATIENT IS WELL. UNFORTUNATELY, THIS INFORMATION HAS NOT YET MADE AVAILABLE. SHOULD FURTHER INFORMATION AND/OR 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 ALSO KINDLY REFER TO MFR REPORTS 9680825-2019-00078 AND 9680825-2019-00080 AND 9680825-2019-00081.
THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: DEVICES CODE: 10008 (COMPRESSION DISTRACTION UNIT STANDARD) & 10009 (COMPRESSION DISTRACTION UNIT LONG). BATCH NUMBER: NOT COMMUNICATED. QUANTITY: 1 UNIT OF CODE 10008 AND THREE UNITS OF CODE 10009 (MFR REPORTS 9680825-2019-00078 AND 9680825-2019-00079 AND 9680825-2019-00080 AND 9680825-2019-00081). HOSPITAL NAME: SHANDONG PROVINCIAL HOSPITAL. SURGEON NAME: DR (B)(6). DATE OF INITIAL SURGERY: (B)(6) 2019. BODY PART TO WHICH DEVICE WAS APPLIED: NO RESPONSE RECEIVED. SURGERY DESCRIPTION: CORRECTION. PATIENT INFORMATION: (B)(6) YEARS, MALE, (B)(6) KG, 170 CM. PROBLEM OBSERVED DURING: HOSPITAL PRE-USE INSPECTION. TYPE OF PROBLEM: OTHER, SEE EVENT DESCRIPTION. EVENT DESCRIPTION: "LOOSENING CLAMP FOUND DURING OPERATION". THE COMPLAINT REPORT FORM ALSO INDICATED: THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT (LOSS OF FRACTURE REDUCTION , LOSS OF ACHIEVED CORRECTION). THE INITIAL SURGERY WAS COMPLETED WITH THE DEVICE. THE EVENT LED TO A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE SURGICAL. PROCEDURE (INCREASE THE TIMES OF INTRAOPERATIVE FLUOROSCOPY AND INTRAOPERATIVE REDUCTION TIME). AN ADDITIONAL SURGERY WAS 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. PRODUCT NOT AVAILABLE FOR RETURN. PATIENT CURRENT HEALTH CONDITION: "AT THE CURRENT STAGE, THE PATIENT HAS BEEN LEFT THE HOSPITAL". NO OTHER INFORMATION WAS PROVIDED. MANUFACTURER REF: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1188368 | COMPRESSION DISTRACTION UNIT LONG | COMPRESSION DISTRACTION UNIT LONG | JDW | ORTHOFIX SRL | E168 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 17 YR | Required Intervention |