SUPPLEMENTARY SCREW HOLDER CLAMP
Report
- Report Number
- 9680825-2019-00082
- 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 90038 LOT B1031529 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2016, WAS COMPRISED OF (B)(4) DEVICES PACKAGED WITH THE LABEL LOT B1036003. 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. (MFR REPORT 9680825-2019-00082). ORTHOFIX SRL CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE COMPONENT CODE 90038 LOT B1042111 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2016, WAS COMPRISED OF (B)(4) DEVICES PACKAGED WITH THE LABEL LOT B1048478. 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. (MFR REPORT 9680825-2019-00083). ORTHOFIX SRL CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE COMPONENT CODE 90038 LOT B1053555 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2016, WAS COMPRISED OF (B)(4) DEVICES PACKAGED WITH THE LABEL LOT B1058553. 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. (MFR REPORT 9680825-2019-00084). ORTHOFIX SRL CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE COMPONENT CODE 90038 LOT B1199236 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2017, WAS COMPRISED OF (B)(4) DEVICES PACKAGED WITH THREE DIFFERENT LABEL LOTS (B1195283, B1203521 AND B1199855). 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. (MFR REPORT 9680825-2019-00085). ORTHOFIX SRL CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE COMPONENT CODE 90038 LOT B1259470 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2018, WAS COMPRISED OF 102 DEVICES PACKAGED WITH THE LABEL LOT B1259470. 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. (MFR REPORTS9680825-2019-00086 AND 9680825-2019-00087). 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. THE RETURNED DEVICES WERE SUBJECTED TO VISUAL, DIMENSIONAL AND FUNCTIONAL CHECK AS PER ORTHOFIX SRL SPECIFICATIONS. 1. DEVICE CODE 90038 LOT B1031529 (MFR 9680825-2019-00082): THE VISUAL AND DIMENSIONAL CHECK DID NOT EVIDENCE ANY ANOMALIES. IT WAS NOT POSSIBLE TO PERFORM THE FUNCTIONAL CHECK AS THE CENTRAL BOLT IS BLOCKED. 2. DEVICE CODE 90038 LOT B1042111 (MFR 9680825-2019-00083): THE VISUAL CHECK EVIDENCED THAT THE CENTRAL PART IS MISSING FROM THE DEVICE RECEIVED. THE DIMENSIONAL CHECK, PERFORMED WHERE POSSIBLE, DID NOT EVIDENCE ANY ANOMALIES. IT WAS NOT POSSIBLE TO PERFORM THE FUNCTIONAL CHECK AS THE CENTRAL PART OF THE DEVICE IS MISSING. 3. DEVICE CODE 90038 LOT B1053555 (MFR 9680825-2019-00084): THE VISUAL AND DIMENSIONAL CHECK DID NOT EVIDENCE ANY ANOMALIES. IT WAS NOT POSSIBLE TO PERFORM THE FUNCTIONAL CHECK AS THE CENTRAL BOLT IS BLOCKED. 4. DEVICE CODE 90038 LOT B1199236 (MFR 9680825-2019-00085): THE VISUAL, DIMENSIONAL AND FUNCTIONAL CHECK DID NOT EVIDENCED ANY ANOMALIES. THE DEVICE STILL PERFORMS PROPERLY. 5. DEVICE CODE 90038 LOT B1259470 (FIRST) (MFR 9680825-2019-00086): THE VISUAL CHECK EVIDENCED THAT THE CENTRAL PART IS MISSING FROM THE DEVICE RECEIVED. THE DIMENSIONAL CHECK, PERFORMED WHERE POSSIBLE, DID NOT EVIDENCE ANY ANOMALIES. IT WAS NOT POSSIBLE TO PERFORM THE FUNCTIONAL CHECK AS THE CENTRAL PART OF THE DEVICE IS MISSING. 6. DEVICE CODE 90038 LOT B1259470 (SECOND) (MFR 9680825-2019-00087): THE VISUAL AND DIMENSIONAL CHECK DID NOT EVIDENCE ANY ANOMALIES. IT WAS NOT POSSIBLE TO PERFORM THE FUNCTIONAL CHECK AS THE CENTRAL BOLT IS BLOCKED. MEDICAL EVALUATION: THE LITTLE INFORMATION MADE AVAILABLE ON THE EVENT WAS SENT TO OUR MEDICAL EVALUATOR. PLEASE FIND BELOW AN EXTRACT OF THE MEDICAL EVALUATION PERFORMED. - NOVEMBER 20, 2019: "I HAVE A PROBLEM WITH THESE TWO REPORTS, (B)(4) & (B)(4) : THE PARTS OF THE FORMS THAT HAVE BEEN FILLED IN ARE IDENTICAL IN BOTH REPORTING FORMS EXCEPT FOR THE PATIENT DETAILS WHICH ARE QUITE DIFFERENT. I THEREFORE FIND IT VERY DIFFICULT TO PLACE ANY IMPORTANCE TO WHAT HAS BEEN WRITTEN. THE FACTS OF THE FORMS ARE JUST NOT BELIEVABLE. I FIND IT VERY STRANGE THAT 6 SUPPLEMENTARY SCREW HOLDERS CLAMPS MALFUNCTIONED AT THE SAME TIME. IT IS FAR MORE LIKELY THAT EITHER THE PIECES HAVE BEEN PROCESSED WRONGLY OR USED WRONGLY. WE DO NOT HAVE EVIDENCE IN ANY FORM THAT THE PATIENT WAS AT RISK AT ANY STAGE, BUT THAT THE OPERATION WAS A BIT LONGER NOT SPECIFIED. THEY CAN DO BETTER THAT THIS". - FEBRUARY 17, 2020 WITH THE RESULTS OF THE TECHNICAL EVALUATION: "THIS REPORT CONCERNS 6 SUPPLEMENTARY SCREW HOLDERS 90038. THE REPORT SUGGESTS THAT THESE 6 UNITS FAILED DURING TREATMENT OF THIS ONE PATIENT. ALTHOUGH THE SURGEON, HOSPITAL AND PATIENT ARE COMPLETELY DIFFERENT FROM THOSE IN COMPLAINT (B)(4) , WHICH INVOLVED COMPRESSION-DISTRACTION UNITS, THE PROBLEM DESCRIPTION IS IDENTICAL: (LOOSENING CLAMP FOUND DURING OPERATION) AND THE CAUSE OF A CLINICALLY RELEVANT INCREASE IN SURGERY TIME IS ALSO IDENTICAL: (INCREASE THE TIMES OF INTRAOPERATIVE FLUOROSCOPY AND INTRAOPERATIVE REDUCTION TIME). FINALLY, AS IN THE PREVIOUS REPORT, THE FINAL COMMENT IS: (AT THE CURRENT STAGE, THE PATIENT HAS BEEN LEAVE HOSPITAL). UNFORTUNATELY THIS COMPLAINT IS NOT CREDIBLE. THE CLAMPS COME FROM 5 DIFFERENT BATCHES, AND ALL OF THEM WERE ORIGINALLY SUPPLIED FULLY TO SPECIFICATION. THE TECHNICAL REPORT SHOWS THAT 2 OF THE 6 UNITS WERE MISSING THE LOCKING BOLT AND NUT; IN 3 OF THE 6 THE NUT AND BOLT WERE COMPLETELY JAMMED, AND IN ONE UNIT EVERYTHING WORKED NORMALLY. THE EXACT NATURE OF THE COMPLAINT IS NOT CLEAR; IN FACT WE HAVE NO IDEA WHAT HAPPENED. I THINK THAT THIS INCIDENT IS DUE TO INCORRECT HANDLING BY THE HOSPITAL. IT WILL BE WORTH ASKING THE DISTRIBUTOR TO CHECK THE EVENTS WITH THE SALES PEOPLE, AS I THINK THAT THERE IS A COMPREHENSION PROBLEM, BUT I THINK THAT YOU HAVE ALREADY DONE THIS". FINAL COMMENTS. THE RESULTS OF THE TECHNICAL EVALUATION EVIDENCED THAT THE RETURNED DEVICES WERE ORIGINALLY CONFORMING TO ORTHOFIX SRL 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: 1. BODY PART TO WHICH DEVICE WAS APPLIED; 2. WHEN THE PROBLEM WAS OBSERVED (DURING SURGERY OR INTO TREATMENT); 3. INFORMATION ABOUT THE FUNCTIONAL PROBLEM HAD WITH THE CLAMPS; 4. PATIENT'S DIAGNOSIS, PLANNED TREATMENT, AND CODE OF THE EXTERNAL FIXATOR USED; 5. DID THE SIX CLAMPS FAIL AT THE SAME TIME OR IN DIFFERENT STAGES OF THE TREATMENT?; 6. ESTIMATION OF THE DELAY OCCURRED DURING SURGERY; 7. CONFIRMATION THAT THE INFORMATION "INCREASE THE TIMES OF INTRAOPERATIVE FLUOROSCOPY AND INTRAOPERATIVE REDUCTION TIME" INCLUDED IN THE COMPLAINT FORM IS RELEVANT TO THIS EVENT; 8. DATE AND OUTCOME OF THE ADDITIONAL INTERVENTION; 9. COPY OF X-RAY IMAGES; 10. 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. IN CASE 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 9680825-2019-00083 AND 9680825-2019-00084 AND 9680825-2019-00085 AND 9680825-2019-00086 AND 9680825-2019-00087.
THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: - DEVICES CODE: 90038 (SUPPLEMENTARY SCREW HOLDER CLAMP); - BATCH NUMBER: B1031529 (QTY 1), B1042111 (QTY 1), B1053555 (QTY 1), B1199236 (QTY 1) AND B1259470 (QTY 2); - QUANTITY: SIX (MFR REPORTS 9680825-2019-00082 AND 9680825-2019-00083 AND 9680825-2019-00084 AND 9680825-2019-00085 AND 9680825-2019-00086 AND 9680825-2019-00087); HOSPITAL NAME: (B)(6) 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: 39 YEARS, MALE, 87 KG, 174 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 THESE CLAMPS. PATIENT'S DIAGNOSIS, PLANNED TREATMENT, AND CODE OF THE EXTERNAL FIXATOR USED. DID THE SIX CLAMPS 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 SRL 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 9680825-2019-00083 AND 9680825-2019-00084 AND 9680825-2019-00085 AND 9680825-2019-00086 AND 9680825-2019-00087.
THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: DEVICES CODE: 90038 (SUPPLEMENTARY SCREW HOLDER CLAMP) . BATCH NUMBER: NOT COMMUNICATED. QUANTITY: SIX (MFR REPORTS 9680825-2019-00082 AND 9680825-2019-00083 AND 9680825-2019-00084 AND 9680825-2019-00085 AND 9680825-2019-00086 AND 9680825-2019-00087). HOSPITAL NAME: (B)(6). 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), MALE, (B)(6), 174 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. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1187897 | SUPPLEMENTARY SCREW HOLDER CLAMP | SUPPLEMENTARY SCREW HOLDER CLAMP | JDW | ORTHOFIX SRL | B1031529 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR | Required Intervention |