OSTEOTITE BONE SCREW 120/30 MM SHAFT D 6MM THREAD D 4.5-3.5MM
Report
- Report Number
- 9680825-2016-00047
- Event Type
- Injury
- Date Received
- May 4, 2016
- Date of Event
- March 31, 2016
- Report Date
- June 8, 2016
- Manufacturer
- ORTHOFIX SRL
- Product Code
- JDW
- PMA / PMN Number
- K974186
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
ANALYSIS OF HISTORICAL RECORDS: ORTHOFIX (B)(4) CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE DEVICE CODE 99-60138, LOT G174 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN SEPTEMBER 2015, WAS COMPRISED OF (B)(4) UNITS. ALL OF THEM HAVE ALREADY BEEN DISTRIBUTED TO THE MARKET. ACCORDING TO ORTHOFIX (B)(4) HISTORICAL RECORDS, THIS IS THE FIRST NOTIFICATION RECEIVED FROM THIS SPECIFIC DEVICE LOT. TECHNICAL EVALUATION: THE TECHNICAL EVALUATION ON THE RETURNED DEVICE, RECEIVED ON APRIL 18, 2016, IS CURRENTLY ON GOING. 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 FURTHER INFORMATION AND/OR THE RESULTS OF THE INVESTIGATION, CURRENTLY ON GOING, ARE AVAILABLE, ORTHOFIX (B)(4) WILL PROVIDE YOU WITH A FOLLOW UP REPORT. ORTHOFIX (B)(4) CONTINUES MONITORING THE DEVICES ON THE MARKET.
ANALYSIS OF HISTORICAL RECORDS ORTHOFIX (B)(4) CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE (B)(4) LOT G174 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. (B)(4). ACCORDING TO ORTHOFIX (B)(4) HISTORICAL RECORDS, THIS IS THE FIRST NOTIFICATION RECEIVED FROM THIS SPECIFIC DEVICE LOT. TECHNICAL EVALUATION: THE RETURNED DEVICE, RECEIVED ON APRIL 18, 2016 WAS EXAMINED BY ORTHOFIX (B)(4) QUALITY ENGINEERING DEPARTMENT. THE DEVICE WAS SUBJECTED TO VISUAL AND DIMENSIONAL CHECK AS PER ORTHOFIX (B)(4) DESIGN AND PRODUCT SPECIFICATIONS. THE VISUAL CHECK CONFIRMED THAT THE DEVICE RETURNED WAS BROKEN. THE KIND OF BREAKAGE OCCURRED IS DUE TO TORSIONAL OVERLOAD, COMPATIBLE WITH THE FAILURE MODE NOTIFIED -BREAKAGE DURING INSERTION. THE SCREW WAS BROKEN AT APPROXIMATELY 12.3 MM FROM THE BEGINNING OF THE THREADED PORTION, THAT MEANS THAT APPROXIMATELY 17.7 MM WERE INSERTED IN PATIENT'S BONE. THIS IS COMPATIBLE WITH THE FAILURE MODE NOTIFIED (BREAKAGE WHEN THE SCREW HIT THE SECOND CORTEX). THE DIMENSIONAL CHECK OF THE THREAD DIAMETER DID NOT EVIDENCE ANY ISSUES. IT WAS NOT PERFORMED THE FUNCTIONAL CHECK AS THE DEVICE WAS BROKEN. THE RAW MATERIAL CHECK CONFIRMED THAT THE DEVICE IS IN CONFORMANCE WITH ORTHOFIX (B)(4) DESIGN SPECIFICATIONS. THE TECHNICAL ANALYSIS PERFORMED EVIDENCED THAT THE RETURNED DEVICE BROKE WHILE INSERTING, DUE TO TORSIONAL OVERLOAD. AS THE SCREW WAS ORIGINALLY CONFORMING TO SPECIFICATIONS, WE MAY CONCLUDE THAT THE BREAKAGE WAS APPLICATION RELATED. MEDICAL EVALUATION: THE INFORMATION MADE AVAILABLE ON THE CASE TOGETHER WITH THE RESULTS OF THE TECHNICAL INVESTIGATION, WAS SENT TO OUR MEDICAL EVALUATOR. PLEASE FIND BELOW AN EXTRACT OF THE MEDICAL EVALUATION: "IN THIS EVENT THE SURGEON WAS ATTEMPTING TO INSERT A 4.5 - 3.5 MM OSTEOTITE BONE SCREW INTO THE TIBIAL OF A (B)(6) ADULT OF NORMAL STATURE. THE SCREW THREAD WAS ONLY 30 MM, SO WE MUST ASSUME THAT THE SCREW WAS BEING INSERTED INTO THE DIAPHYSIS. I CANNOT UNDERSTAND WHY THIS SCREW WAS USED IN THIS POSITION. I CONSIDER THAT SCREW BREAKAGE WHEN IT REACHED THE SECOND CORTEX WAS ALMOST INEVITABLE. IN PQ_EXF, WARNINGS AND PRECAUTIONS NO. 9, IS WRITTEN: "SCREW DIAMETER SHOULD BE SELECTED IN ACCORDANCE WITH BONE DIAMETER: FOR A BONE DIAMETER GREATER THAN 20 MM, 6-5 OR 6-5.6 MM BONE SCREWS SHOULD BE USED; FOR A BONE DIAMETER BETWEEN 12 AND 20 MM, 4.5-3.5 MM BONE SCREWS; AND FOR A BONE DIAMETER BETWEEN 9 AND 12 MM, 3.5-3.2 MM BONE SCREWS SHOULD BE USED." THE TIBIAL DIAPHYSEAL CORTEX OF AN ADULT MALE IS VERY HARD, AND TORSIONAL FAILURE OF A SCREW OF THIS DIAMETER IN THIS POSITION IS ALMOST INEVITABLE. ALSO THE DIAMETER OF THE BONE WILL BE A MINIMUM OF 25 TO 30 MM." ADDITIONAL MEDICAL EVALUATION BASED ON THE RESULTS OF THE TECHNICAL ANALYSIS: "IN THE TECHNICAL ANALYSIS IT IS STATED: THE SCREW WAS BROKEN AT APPROXIMATELY 12.3 MM FROM THE BEGINNING OF THE THREADED PORTION, THAT MEANS THAT APPROXIMATELY 17.7 MM WERE INSERTED IN PATIENT'S BONE. > THE DISTANCE STATED IS AN EXACT FIT WITH WHAT WOULD BE EXPECTED IN AN ADULT TIBIAL DIAPHYSIS. IN THIS CASE A 4.5 - 3.5 MM OSTEOTITE SCREW BROKE WHILE BEING INSERTED INTO AN ADULT TIBIAL DIAPHYSIS. THIS IS CERTAINLY AN INCORRECT APPLICATION. " FINAL COMMENTS: THE TECHNICAL ANALYSIS PERFORMED EVIDENCED THAT THE RETURNED DEVICE BROKE WHILE INSERTING DUE TO TORSIONAL OVERLOAD. AS THE SCREW WAS ORIGINALLY CONFORMING TO SPECIFICATIONS, WE MAY CONCLUDE THAT THE BREAKAGE WAS APPLICATION RELATED. THE MEDICAL EVALUATION EVIDENCED AS FOLLOWS: "IN THIS EVENT THE SURGEON WAS ATTEMPTING TO INSERT A 4.5 - 3.5 MM OSTEOTITE BONE SCREW INTO THE TIBIAL OF A (B)(6) ADULT OF NORMAL STATURE. THE SCREW THREAD WAS ONLY 30 MM, SO WE MUST ASSUME THAT THE SCREW WAS BEING INSERTED INTO THE DIAPHYSIS. I CANNOT UNDERSTAND WHY THIS SCREW WAS USED IN THIS POSITION. I CONSIDER THAT SCREW BREAKAGE WHEN IT REACHED THE SECOND CORTEX WAS ALMOST INEVITABLE. IN PQ_EXF, WARNINGS AND PRECAUTIONS NO. 9, IS WRITTEN: "SCREW DIAMETER SHOULD BE SELECTED IN ACCORDANCE WITH BONE DIAMETER: FOR A BONE DIAMETER GREATER THAN 20 MM, 6-5 OR 6-5.6 MM BONE SCREWS SHOULD BE USED; FOR A BONE DIAMETER BETWEEN 12 AND 20 MM, 4.5-3.5 MM BONE SCREWS; AND FOR A BONE DIAMETER BETWEEN 9 AND 12 MM, 3.5-3.2 MM BONE SCREWS SHOULD BE USED." "THE TIBIAL DIAPHYSEAL CORTEX OF AN ADULT MALE IS VERY HARD, AND TORSIONAL FAILURE OF A SCREW OF THIS DIAMETER IN THIS POSITION IS ALMOST INEVITABLE. ALSO THE DIAMETER OF THE BONE WILL BE A MINIMUM OF 25 TO 30 MM. THIS IS CERTAINLY AN INCORRECT APPLICATION." THE AVAILABLE INFORMATION ON THE EVENT LEAD TO INFER THAT FAILURE OF THE DEVICE, OCCURRED DUE TO AN IMPROPER SELECTION OF THE SCREW SIZE. ORTHOFIX (B)(4) WOULD LIKE TO REMIND THE IMPORTANCE OF OBSERVING ALL PRECAUTIONS LISTED IN THE PRODUCT INSTRUCTIONS FOR USE, ORTHOFIX BONE SCREWS FOR EXTERNAL FIXATION SYSTEM, REF: PQ SCR. PLEASE FIND BELOW AN EXTRACT FROM THE APPLICABLE IFU, REF: PQ SCR, SECTION "WARNINGS": "5. SCREW DIAMETER SHOULD BE SELECTED IN ACCORDANCE WITH BONE DIAMETER. THE MAXIMUM DIAMETER OF THE SCREW THREAD SHOULD NOT BE GREATER THAN ONE THIRD OF THE BONE DIAMETER (E.G. 6-5 OR 6-5.6 MM BONE SCREWS FOR BONE DIAMETER GREATER THAN 20 MM)." BASED ON THE RESULTS OF THE TECHNICAL EVALUATION PERFORMED ON THE RETURNED DEVICE, THAT EVIDENCED ITS CONFORMITY TO ORTHOFIX (B)(4) SPECIFICATIONS, AND ON THE EVIDENCES DERIVING FROM THE MEDICAL EVALUATION, ORTHOFIX (B)(4) CAN CONCLUDE THAT THE PROBLEM OCCURRED IS NOT DEVICE RELATED. ORTHOFIX (B)(4) CONTINUES MONITORING THE DEVICES ON THE MARKET.
THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: PRODUCT CODE: 99-60138 . BATCH NUMBER: G174. QUANTITY: 1. HOSPITAL NAME: (B)(6) HOSPITAL. SURGEON NAME: MR. (B)(6). DATE OF SURGERY: (B)(6) 2016. BODY PART TO WHICH DEVICE WAS APPLIED: TIBIA. SURGERY DESCRIPTION: FRACTURE TREATMENT. PATIENT INFORMATION: (B)(6) MALE, PREVIOUS HEALTH CONDITION: N/A. PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: LAST THURSDAY, MR (B)(6) AT (B)(6) HOSPITAL HAD AN INSTANCE OF A BROKEN HALF PIN DURING A PROCEDURE TO APPLY A TL TRAUMA FRAME. THE NORMAL INSERTION TECHNIQUE WAS BEING FOLLOWED FOR THE 99-60138. THE CONSULTANT HAD PRE-DRILLED THE TIBIA WITH A 3.2MM DRILL BIT AND WAS INSERTING THE HALF PIN AND HIT THE SECOND CORTEX WHEN THE HALF PIN BROKE WITHIN THE THREAD SECTION. I HAVE RECOVERED THE HALF PIN. IT WAS SOAKED IN CHLORHEX AND CLEANED OF ANY DEBRIS. IT DID NOT STOP MR (B)(6) FROM COMPLETING THE CASE SUCCESSFULLY. REMAINDER OF SCREW INSIDE PATIENT - CONSULTANT PLANS TO LEAVE IN SITU. THE COMPLAINT REPORT FORM INDICATES: THE DEVICE FAILURE HAD NO ADVERSE EFFECTS ON PATIENT; THE CONSEQUENCE OF FAILURE WAS UN-RETRIEVED DEVICE FRAGMENT; THE SURGERY WAS COMPLETED WITH USED DEVICE. THE EVENT DID NOT LEAD TO A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE SURGICAL PROCEDURE; ADDITIONAL SCREW REQUIRED, HOWEVER, ADDITIONAL TIME REQUIRED WAS 5-10 MINS AND NOT IMPORTANT. AN ADDITIONAL SURGERY WAS NOT REQUIRED FOLLOWING DEVICE FAILURE. COPIES OF THE OPERATIVE REPORTS ARE NOT AVAILABLE. COPIES OF THE X-RAYS ARE NOT AVAILABLE -REQUESTED FOR FEW IMAGES. PATIENT CURRENT HEALTH CONDITION: PROGRESSING WELL WITH TREATMENT. (B)(4).
THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: PRODUCT CODE: 99-60138, BATCH NUMBER: (B)(4), QUANTITY: 1, HOSPITAL NAME: (B)(6) HOSPITAL, SURGEON NAME: MR. (B)(6), DATE OF SURGERY: (B)(6) 2016, BODY PART TO WHICH DEVICE WAS APPLIED: TIBIA, SURGERY DESCRIPTION: FRACTURE TREATMENT, PATIENT INFORMATION: (B)(6), MALE, (B)(6), PREVIOUS HEALTH CONDITION: N/A, PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT/INTRAOPERATIVE, TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM, EVENT DESCRIPTION: LAST THURSDAY, MR (B)(6) AT (B)(6) HOSPITAL HAD AN INSTANCE OF A BROKEN HALF PIN DURING A PROCEDURE TO APPLY A TL TRAUMA FRAME. THE NORMAL INSERTION TECHNIQUE WAS BEING FOLLOWED FOR THE 99-60138. THE CONSULTANT HAD PRE-DRILLED THE TIBIA WITH A 3.2MM DRILL BIT AND WAS INSERTING THE HALF PIN AND HIT THE SECOND CORTEX WHEN THE HALF PIN BROKE WITHIN THE THREAD SECTION. I HAVE RECOVERED THE HALF PIN. IT WAS SOAKED IN CHLORHEX AND CLEANED OF ANY DEBRIS. IT DID NOT STOP MR (B)(6) FROM COMPLETING THE CASE SUCCESSFULLY. REMAINDER OF SCREW INSIDE PATIENT - CONSULTANT PLANS TO LEAVE IN SITU. THE COMPLAINT REPORT FORM INDICATES: THE DEVICE FAILURE HAD NO ADVERSE EFFECTS ON PATIENT; THE CONSEQUENCE OF FAILURE WAS UN-RETRIEVED DEVICE FRAGMENT; THE SURGERY WAS COMPLETED WITH USED DEVICE. THE EVENT DID NOT LEAD TO A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE SURGICAL PROCEDURE; ADDITIONAL SCREW REQUIRED, HOWEVER ADDITIONAL TIME REQUIRED WAS 5-10 MINS AND NOT IMPORTANT. AN ADDITIONAL SURGERY WAS NOT REQUIRED FOLLOWING DEVICE FAILURE. COPIES OF THE OPERATIVE REPORTS ARE NOT AVAILABLE. COPIES OF THE X-RAYS ARE NOT AVAILABLE -REQUESTED FOR FEW IMAGES. PATIENT CURRENT HEALTH CONDITION: PROGRESSING WELL WITH TREATMENT. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 286490 | OSTEOTITE BONE SCREW 120/30 MM SHAFT D 6MM THREAD D 4.5-3.5MM | OSTEOTITE BONE SCREW 120/30 MM SHAFT D 6MM THREAD D 4.5-3.5MM | JDW | ORTHOFIX SRL | 99-60138 | G174 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Required Intervention |