CHIMAERA HFS LAG SCREW SLIDING L95MM STERILE
Report
- Report Number
- 9680825-2022-00024
- Event Type
- Injury
- Date Received
- January 3, 2023
- Report Date
- February 28, 2023
- Manufacturer
- ORTHOFIX SRL
- Product Code
- HSB
- PMA / PMN Number
- K161466
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- 003
Narratives
ANALYSIS OF HISTORICAL RECORDS : ORTHOFIX SRL CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE DEVICE (B)(4) BATCH B1656216 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2021, 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 IN REGARDS TO THIS SPECIFIC DEVICE LOT. TECHNICAL EVALUATION: THE INVOLVED DEVICE WAS NOT RETURNED TO ORTHOFIX FOR ANALYSIS, AS IT WAS DISCARDED AT THE HOSPITAL. THE EVALUATION OF THE EVENT DESCRIPTION IS IN PROGRESS. 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 INVESTIGATION ARE AVAILABLE. AS SOON AS THE RESULTS OF THE INVESTIGATION ARE AVAILABLE, ORTHOFIX SRL WILL PROVIDE A FOLLOW UP REPORT. ORTHOFIX SRL CONTINUES MONITORING THE DEVICES ON THE MARKET.
ANALYSIS OF HISTORICAL RECORDS ORTHOFIX SRL CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE ON THE DEVICE CODE 99-T93795 BATCH B1656216 BEFORE THE MARKET RELEASE. NO ANOMALIES HAVE BEEN FOUND. THE ORIGINAL LOT, MANUFACTURED IN 2021, WAS COMPRISED OF 25 DEVICES. 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. TECHNICAL EVALUATION THE DEVICE INVOLVED IN THIS EVENT WAS NOT RETURNED TO ORTHOFIX SRL AS IT WAS DISPOSED OF AT THE HOSPITAL. THEREFORE, IT WAS NOT POSSIBLE TO PERFORM THE TECHNICAL EVALUATION. MEDICAL EVALUATION THE INFORMATION MADE AVAILABLE ON THE EVENT WAS SENT TO OUR MEDICAL EVALUATOR. PLEASE FIND BELOW AN EXTRACT OF THE MEDICAL EVALUATION PERFORMED. -I UNDERSTAND THAT THE PATIENT SUSTAINED A TROCHANTERIC FRACTURE WHICH WAS TREATED WITH A CHIMAERA NAIL WITH 2 LAG SCREWS. IT WAS NOTICED THAT THE FIXATION WAS FAILING AT 5 MONTHS FOLLOW UP BUT THE PATIENT DECLINED TREATMENT. SHE FINALLY AGREED TO HAVE A REVISION HIP REPLACEMENT AFTER 12 MONTHS, ALSO REMARKABLE. I WOULD GUESS THAT THE PATIENT IS NOW DOING WELL. THE DELAY WAS BECAUSE OF THE PATIENT'S WISHES, BUT THE REVISION SURGERY WAS NEEDED BECAUSE THE IMPLANT FAILED. -COMMENTS ON THE X-RAY: CLEARLY THE MAIN LAG SCREW WAS NOT ENGAGED WITH THE NAIL WHEN INSERTED, AS HAS BEEN INDEED SUGGESTED IN THE REPORT, SO IT HAS COME OUT. THE SUPPLEMENTARY LAG SCREW WAS THEN HOLDING THE ENTIRE WEIGHT OF THE PATIENT, AND IT IS NOT DESIGNED FOR THIS, AND CUT OUT. I WOULD ALSO SUGGEST THAT THE MAIN LAG SCREW IS TOO PROXIMAL AND WAS NOT INSERTED FAR ENOUGH (THE TIP SHOULD BE 5 - 10 MM FROM THE ARTICULAR SURFACE). IT SHOULD HAVE BEEN CLOSER TO THE CALCAR. BECAUSE OF THIS THE SUPPLEMENTARY LAG SCREW WAS TOO CLOSE TO THE SUPERIOR EDGE OF THE NECK AND CUT OUT EASILY. FINAL COMMENTS A TECHNICAL EVALUATION OF THE INVOLVED DEVICE WAS NOT PERFORMED AS IT WAS DISPOSED OF AT THE HOSPITAL. CONSIDERING THE INFORMATION PROVIDED ON THE EVENT AND THAT THE INVOLVED DEVICE WAS NOT RETURNED FOR ANALYSIS, IT IS NOT POSSIBLE TO FINALIZE THE INVESTIGATION AND DETERMINE THE ROOT CAUSE OF THE ISSUE OCCURRED. THE ANALYSIS OF THE HISTORICAL DATA EVIDENCED THAT NO OTHER NOTIFICATIONS HAVE BEEN RECEIVED ON THIS SPECIFIC DEVICE LOT. IN CASE FURTHER INFORMATION IS PROVIDED, ORTHOFIX SRL WILL PROMPTLY RE-OPEN THE INVESTIGATION ON THE CASE. ORTHOFIX SRL CONTINUES MONITORING THE PRODUCTS ON THE MARKET.
THE INFORMATION INITIALLY PROVIDED BY THE LOCAL DISTRIBUTOR INDICATED: HOSPITAL NAME: (B)(6). SURGEON'S NAME: (B)(6). DATE OF INITIAL SURGERY: (B)(6) 2021. BODY PART TO WHICH DEVICE WAS APPLIED: R HIP. SURGERY DESCRIPTION: FRACTURE TREATMENT. PATIENT INFORMATION: 86 YEAR-OLD, FEMALE, PREVIOUS HEALTH CONDITION: RENAL OSTEODYSTROPHY AND UNDERGOING DIALYSIS 4 PER WEEK FOR THE LAST 10 YEARS PER PHYSICIAN. PROBLEM OBSERVED DURING: INTO TREATMENT/POST-OPERATIVE. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: SURGEON REPORTS THAT PATIETN WAS IN NEED OF REVISION 5 MONTHS AFTER INITIAL SURGERY DUE TO THE LAG SCREW BACKING OUT AND HE STATED HE BELIEVED HE MAY NOT HAVE LOCKED IT IN ALL THE WAY. THE SUPPLEMENTARY SCREW CUT OUT OF THE FEMORAL HEAD AND THE PHYSICIAN STATED IT WAS MOST LIKELY DUE TO POOR BONE QUALITY. PATIENT WAS REVISED TO REVISION STEM THA 1 YEAR LATER. THE LAG SCREW CAME OUT IN 2 SEPARATE PIECES DUE TO THE THREADED SIDE BEING DISASSOCIATED WITH THE NON SLIDING PART. LEADING TO A REVISION TOTAL HIP. THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT. THE INITIAL SURGERY WAS COMPLETED WITH THE DEVICE . THE EVENT DID NOT LEAD TO A DELAY IN THE DURATION OF THE SURGICAL PROCEDURE. AN ADDITIONAL SURGERY WAS REQUIRED: PERFORMED ON (B)(6) 2022. A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED. COPIES OF THE OPERATIVE REPORTS ARE NOT AVAILABLE. COPIES OF THE X-RAY IMAGES ARE AVAILABLE. PATIENT CURRENT HEALTH CONDITION: PHYSICIAN REPORTED THAT PATIENT HAD A SUCCESSFUL FOLLOW POST REVISION THA AND HAS HAD NO ISSUES DUE TO THE ORIGINAL SURGERY. FURTHER INFORMATION RECEIVED ON 27 DECEMBER 2022: THE PATIENT RECEIVED HER FIRST SURGERY 1 YEAR PRIOR TO THE REVISION ((B)(6) 2021). THE LAG SCREW PROTRUDING WAS NOTICED 5+ MONTHS BEFORE THE REVISION ((B)(6) 2022). MANUFACTURER REF: (B)(4). DISTRIBUTOR REF: FC (B)(4).
THE INFORMATION INITIALLY PROVIDED BY THE LOCAL DISTRIBUTOR INDICATED: - HOSPITAL NAME: (B)(6), NV. - SURGEON'S NAME: (B)(6). - DATE OF INITIAL SURGERY: (B)(6) 2021. - BODY PART TO WHICH DEVICE WAS APPLIED: R HIP. - SURGERY DESCRIPTION: FRACTURE TREATMENT. - PATIENT INFORMATION: 86 YEAR-OLD, FEMALE, PREVIOUS HEALTH CONDITION: RENAL. OSTEODYSTROPHY AND UNDERGOING DIALYSIS 4 PER WEEK FOR THE LAST 10 YEARS PER PHYSICIAN - PROBLEM OBSERVED DURING: INTO TREATMENT/POST-OPERATIVE. - TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. - EVENT DESCRIPTION: SURGEON REPORTS THAT PATIETN WAS IN NEED OF REVISION 5 MONTHS AFTER INITIAL SURGERY DUE TO THE LAG SCREW BACKING OUT AND HE STATED HE BELIEVED HE MAY NOT HAVE LOCKED IT IN ALL THE WAY. THE SUPPLEMENTARY SCREW CUT OUT OF THE FEMORAL HEAD AND THE PHYSICIAN STATED IT WAS MOST LIKELY DUE TO POOR BONE QUALITY. PATIENT WAS REVISED TO REVISION STEM THA 1 YEAR LATER. THE LAG SCREW CAME OUT IN 2 SEPARATE PIECES DUE TO THE THREADED SIDE BEING DISASSOCIATED WITH THE NON SLIDING PART. LEADING TO A REVISION TOTAL HIP. THE COMPLAINT REPORT FORM ALSO INDICATES: - THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT. - THE INITIAL SURGERY WAS COMPLETED WITH THE DEVICE. - THE EVENT DID NOT LEAD TO A DELAY IN THE DURATION OF THE SURGICAL PROCEDURE. - AN ADDITIONAL SURGERY WAS REQUIRED: PERFORMED ON (B)(6) 2022. - A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED. - COPIES OF THE OPERATIVE REPORTS ARE NOT AVAILABLE. - COPIES OF THE X-RAY IMAGES ARE AVAILABLE. - PATIENT CURRENT HEALTH CONDITION: PHYSICIAN REPORTED THAT PATIENT HAD A SUCCESSFUL FOLLOW POST REVISION THA AND HAS HAD NO ISSUES DUE TO THE ORIGINAL SURGERY. NOTE: THE INVOLVED SCREW WILL NOT BE RETURNED TO ORTHOFIX FOR ANALYSIS, AS IT WAS DISCARDED AT THE HOSPITAL. FURTHER INFORMATION RECEIVED ON 27 DECEMBER 2022: THE PATIENT RECEIVED HER FIRST SURGERY 1 YEAR PRIOR TO THE REVISION (B)(6) 2021). THE LAG SCREW PROTRUDING WAS NOTICED 5+ MONTHS BEFORE THE REVISION ((B)(6) 2022). MANUFACTURER REF: (B)(4). DISTRIBUTOR REF: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 132130 | CHIMAERA HFS LAG SCREW SLIDING L95MM STERILE | CHIMAERA HFS LAG SCREW SLIDING L95MM STERILE | HSB | ORTHOFIX SRL | 99-T93795 | B1656216 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR | Female | Required Intervention |