CHIMAERA HFS LAG SCREW SLIDING L85MM STERILE
Report
- Report Number
- 9680825-2017-00044
- Event Type
- Injury
- Date Received
- June 20, 2017
- Report Date
- August 2, 2017
- Manufacturer
- ORTHOFIX SRL
- Product Code
- HSB
- UDI-DI
- 18054242514732
- PMA / PMN Number
- K161466
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
Narratives
ANALYSIS OF HISTORICAL RECORDS (INFORMATION ALREADY PROVIDED) ORTHOFIX SRL CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE LAG SCREW CODE 99-T93785 BATCH V1431151 (LOT LASER MARKED ON THE SCREW IS V1430298) BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2016, WAS COMPRISED OF 108 DEVICES. 83 OF THEM HAVE ALREADY BEEN DISTRIBUTED TO THE MARKET. ACCORDING TO ORTHOFIX SRL HISTORICAL RECORDS, THIS IS THE FIRST COMPLAINT RECEIVED FROM THIS SPECIFIC DEVICE LOT. TECHNICAL EVALUATION (INFORMATION REVISED): THE RETURNED SCREW, RECEIVED ON MAY 25, 2017 WAS EXAMINED BY ORTHOFIX SRL QUALITY ENGINEERING AREA. THE DEVICE WAS SUBJECTED TO VISUAL, DIMENSIONAL AND FUNCTIONAL CHECK AS PER ORTHOFIX SRL SPECIFICATION. THE VISUAL CHECK EVIDENCED PRESENCE OF SOME MARKS ON THE SCREW SURFACE. THESE SIGNS ARE COMPATIBLE WITH THE DEVICE USE, INCLUDING THE ACTIVATION OF THE SLIDING FUNCTION. THE DIMENSIONAL CHECK DID NOT EVIDENCE ANY ANOMALIES. THE FUNCTIONAL CHECK EVIDENCED PRESENCE OF ORGANIC RESIDUAL BETWEEN THE INNER SCREW AND THE BARREL THAT INITIALLY PREVENTED THE SLIDING. THE DEVICE WAS CLEANED AND THEN THE FUNCTIONAL CHECK WAS REPEATED. NO ANOMALIES HAVE BEEN FOUND; THE DEVICE WORKS PROPERLY. THE RESULTS OF THE TECHNICAL EVALUATION CONCLUDED THAT THE DEVICE, AFTER A CLEANING ACTIVITY PERFORMED BY ORTHOFIX, STILL PERFORMS PROPERLY. ORTHOFIX CANNOT DETERMINE WHETHER THE RESIDUAL SEIZED THE SLIDING MECHANISM DURING TREATMENT OR AFTER REMOVAL. NEVERTHELESS IT CAN BE STRESSED THAT DRY ORGANIC RESIDUAL OFTEN CAUSES STICKING OF COMPONENTS INTENDED FOR RELATIVE MOVEMENT. MEDICAL EVALUATION (NEW INFORMATION): THE INFORMATION MADE AVAILABLE ON THE CASE TOGETHER WITH THE RESULTS OF THE TECHNICAL EVALUATION WERE SENT TO OUR MEDICAL EVALUATOR. PLEASE FIND BELOW AN EXTRACT OF THE MEDICAL EVALUATIONS PERFORMED. (B)(6) 2017: "CUT OUT OF THE CEPHALIC SCREWS IS A KNOWN COMPLICATION OF THE INTERNAL FIXATION OF TROCHANTERIC FRACTURES. IN 1995 A PAPER DESCRIBED THE EFFECT OF THE TIP APEX DISTANCE IN THE CUT OUT RATE OF THE CEPHALIC SCREWS WHEN USED FOR TROCHANTERIC FRACTURES. "BAUMGAERTNER MR, CURTIN SL, LINDSKOG DM, KEGGI JM. THE VALUE OF THE TIP-APEX DISTANCE (TAD) IN PREDICTING FAILURE OF FIXATION OF PERITROCHANTERIC FRACTURES OF THE HIP. J BONE JOINT SURG AM 1995; 77A: 1058-64". AS FAR AS I AM AWARE THE INFORMATION IN THIS PAPER HAS BEEN CONFIRMED BY OTHER STUDIES AND REMAINS TRUE TODAY FOR THOSE IMPLANTS WITH A SINGLE CEPHALIC SCREW. THE CALCULATION OF TAD HAS BEEN REPORTED IN DETAIL, AND IS THE SUM OF THE DISTANCES IN MM FROM THE TIP OF THE LAG SCREW TO THE APEX OF THE FEMORAL HEAD ON AP AND LATERAL RADIOGRAPHS. THE SUM SHOULD IDEALLY BE LESS THAN 25 MM. USING THE KNOWN DIAMETER OF THE CEPHALIC SCREW (10.5 MM) I CALCULATE THAT THE TAD IN THIS PATIENT IS 33.8 MM. IN THE 1995 PAPER THE CUT OUT RATE IF THE TAD WAS 25 MM OR LESS WAS ZERO, AND INCREASED WITH AN ENLARGING TAD. IN THIS CASE THE FRACTURE WAS NICELY REDUCED, BUT THE CEPHALIC SCREW WAS NOT POSITIONED TO GIVE A TAD OF <25 MM, AND THE RISK OF CUT OUT WAS SIGNIFICANT AS A RESULT. THE PATIENT HAD A PREVIOUS DISTAL FEMORAL FRACTURE AND HAS AN IMPLANT IN SITU BUT I DO NOT THINK THAT THIS WAS RELEVANT TO THE FAILURE. THIS WAS A TYPICAL PATIENT FOR WHOM THIS IMPLANT HAS BEEN DESIGNED. THE FRACTURE IS A REVERSE OBLIQUE 4 PART TROCHANTERIC FRACTURE. IF A SINGLE CEPHALIC SCREW IS TO BE USED, IT MUST BE CENTRALLY PLACED WITH THE TIP CLOSE TO THE ARTICULAR SURFACE. IN THIS CASE A CENTRAL PROTRUSION OF THE CEPHALIC SCREW CAUSED A DRAMATIC DISINTEGRATION OF THE PROXIMAL FEMUR AND THE PATIENT REQUIRED A TOTAL HIP REPLACEMENT. IN MY VIEW THE CUT OUT WAS MADE MUCH MORE LIKELY BECAUSE THE TAD WAS NOT < 25 MM, AND THIS FRACTURE FIXATION FAILED BECAUSE OF TECHNICAL REASONS RELATING TO THE OPERATION". (B)(4) 2017 WITH THE RESULTS OF THE TECHNICAL EVALUATION: "I AGREE WITH THE CONCLUSIONS OF THE TECHNICAL ANALYSIS THAT THE RESIDUES IDENTIFIED IN THE SCREW SLIDING MECHANISM WERE AS A RESULT OF THE SURGERY AND NOT THE CAUSE OF THE LACK OF DYNAMISATION. I REITERATE MY PREVIOUS COMMENTS: WE KNOW THAT THIS OCCURS SOMETIMES WHEN THESE FRACTURES ARE TREATED WITH A SINGLE CEPHALIC SCREW, AND THE EXACT POSITION OF THE SCREW HAS BEEN SHOW TO BE VERY IMPORTANT TO PREVENT CUT-OUT. THIS DEVICE CUT OUT BECAUSE OF TECHNICAL REASONS RELATING TO THIS PARTICULAR OPERATION". FINAL COMMENTS: THE RESULTS OF THE TECHNICAL EVALUATION CONCLUDED THAT THE DEVICE, AFTER A CLEANING ACTIVITY PERFORMED BY ORTHOFIX, STILL PERFORMS PROPERLY.
ANALYSIS OF HISTORICAL RECORDS ORTHOFIX (B)(4) CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE LAG SCREW CODE 99-T93785 BATCH V1431151 (LOT LASER MARKED ON THE SCREW IS V1430298) BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2016, WAS COMPRISED OF (B)(4) DEVICES. (B)(4) OF THEM HAVE ALREADY BEEN DISTRIBUTED TO THE MARKET. ACCORDING TO ORTHOFIX (B)(4) HISTORICAL RECORDS, THIS IS THE FIRST COMPLAINT RECEIVED FROM THIS SPECIFIC DEVICE LOT. TECHNICAL EVALUATION THE RETURNED SCREW, RECEIVED ON MAY 25, 2017 WAS EXAMINED BY ORTHOFIX (B)(4) QUALITY ENGINEERING AREA. THE DEVICE WAS SUBJECTED TO VISUAL, DIMENSIONAL AND FUNCTIONAL CHECK AS PER ORTHOFIX (B)(4) SPECIFICATION. THE VISUAL CHECK EVIDENCED PRESENCE OF SOME MARKS ON THE SCREW SURFACE. THESE SIGNS ARE COMPATIBLE WITH THE DEVICE USE. THE DIMENSIONAL CHECK DID NOT EVIDENCE ANY ANOMALIES. THE FUNCTIONAL CHECK EVIDENCED PRESENCE OF ORGANIC RESIDUAL BETWEEN THE INNER SCREW AND THE BARREL. THE DEVICE WAS CLEANED AND THEN THE FUNCTIONAL CHECK WAS REPEATED. NO ANOMALIES HAVE BEEN FOUND; THE DEVICE WORKS PROPERLY. THE RESULTS OF THE TECHNICAL EVALUATION CONCLUDED THAT THE DEVICE, AFTER A CLEANING ACTIVITY PERFORMED BY ORTHOFIX, STILL PERFORMS PROPERLY. 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 FURTHER INFORMATION ON THE EVENT BECOMES AVAILABLE. ORTHOFIX (B)(4) HAD REQUESTED FURTHER INFORMATION ON THE EVENT SUCH AS NAME AND ADDRESS OF THE HOSPITAL INVOLVED, DATE OF THE INITIAL SURGERY, DATE OF THE DEVICE FAILURE, DATE OF THE SYSTEM REMOVAL, PATIENT INFORMATION (AGE, SEX AND WEIGHT), COPIES OF THE OPERATIVE REPORTS AND INFORMATION ABOUT PATIENT CURRENT HEALTH CONDITION. UNFORTUNATELY, THIS INFORMATION HAS NOT BEEN MADE 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.
THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6); SURGEON NAME: DR. (B)(6); DATE OF SURGERY: 6 WEEKS AGO; BODY PART TO WHICH DEVICE WAS APPLIED: HIP; SURGERY DESCRIPTION: FRACTURE TREATMENT; PATIENT INFORMATION: NO RESPONSE PROVIDED; PROBLEM OBSERVED DURING: NO RESPONSE PROVIDED; TYPE OF PROBLEM: NO RESPONSE PROVIDED. EVENT DESCRIPTION: AFTER HIP FRACTURE AFTER 6 WEEKS, CUT OUT WITH CHIMAERA, IT SEEMS THAT THE LAG SCREW DIDN'T WORK.....NO DYNAMISATION.......I HAVE THE IMPLANT WITH ME AND WILL SEND THE PICTURES WITH, TELL ME IF I CAN SEND YOU THE IMPLANTS. DR (B)(6) HAD TO REMOVE AND CHANGE WITH TOTAL HIP REPLACEMENT. THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT; THE INITIAL SURGERY WAS NOT COMPLETED WITH THE DEVICE; AN ADDITIONAL SURGERY WAS REQUIRED; AVAILABILITY ABOUT COPIES OF THE OPERATIVE REPORTS: NO RESPONSE PROVIDED; COPIES OF THE X-RAYS IMAGES ARE AVAILABLE; INFORMATION ABOUT PATIENT CURRENT HEALTH CONDITION: NO RESPONSE PROVIDED. MANUFACTURER REFERENCE NUMBER: (B)(4).
THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: - HOSPITAL NAME: (B)(6); - SURGEON NAME: DR. (B)(6); - DATE OF SURGERY: (B)(6); - BODY PART TO WHICH DEVICE WAS APPLIED: HIP; - SURGERY DESCRIPTION: FRACTURE TREATMENT; - PATIENT INFORMATION: NO RESPONSE PROVIDED; - PROBLEM OBSERVED DURING: NO RESPONSE PROVIDED; - TYPE OF PROBLEM: NO RESPONSE PROVIDED. - EVENT DESCRIPTION: AFTER HIP FRACTURE AFTER 6 WEEKS, CUT OUT WITH CHIMAERA, IT SEEMS THAT THE LAG SCREW DIDN'T WORK.....NO DYNAMISATION.......I HAVE THE IMPLANT WITH ME AND WILL SEND THE PICTURES WITH, TELL ME IF I CAN SEND YOU THE IMPLANTS. DR (B)(6) HAD TO REMOVE AND CHANGE WITH TOTAL HIP REPLACEMENT. THE COMPLAINT REPORT FORM ALSO INDICATES: - THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT; - THE INITIAL SURGERY WAS NOT COMPLETED WITH THE DEVICE; - AN ADDITIONAL SURGERY WAS REQUIRED; - AVAILABILITY ABOUT COPIES OF THE OPERATIVE REPORTS: NO RESPONSE PROVIDED; - COPIES OF THE X-RAYS IMAGES ARE AVAILABLE; - INFORMATION ABOUT PATIENT CURRENT HEALTH CONDITION: NO RESPONSE PROVIDED. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 433602 | CHIMAERA HFS LAG SCREW SLIDING L85MM STERILE | CHIMAERA HFS LAG SCREW SLIDING L85MM STERILE | HSB | ORTHOFIX SRL | 99-T93785 | V1431151 | 18054242514732 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |