Z NAIL CMF 10.5 X 90 LAG SCR
Report
- Report Number
- 0009613350-2021-00286
- Event Type
- Malfunction
- Date Received
- June 16, 2021
- Date of Event
- May 1, 2021
- Report Date
- November 19, 2021
- Manufacturer
- ZIMMER SWITZERLAND MANUFACTURING GMBH
- Product Code
- HWC
- PMA / PMN Number
- N/A
- Removal / Correction Number
- N/A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
INVESTIGATION RESULTS WERE MADE AVAILABLE. REVIEW OF EVENT DESCRIPTION: IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH CM FORTIS SYSTEM ON (B)(6) 2021. ON NEXT DAY X-RAYS REVEALED THAT AS SCREW WAS BACKED OUT FROM THE IMPLANTED POSITION. AFTER ONE WEEK, TLS WAS ALSO BACKED OUT. IT WAS ALSO NOTICED THAT SLEEVE PART WAS BACKED OUT WITHOUT THE TELESCOPING PART SLIDING IN. NO REVISION SURGERY WAS PLANNED SO FAR. REVIEW OF RECEIVED DATA: DUE DILIGENCE: NO FURTHER DUE DILIGENCE REQUIRED AS ALL REQUIRED INFORMATION TO SUPPORT THE CONCLUSION IS AVAILABLE OR WAS ALREADY REQUESTED. X-RAYS: SEVERAL X-RAYS HAVE BEEN RECEIEVED. THE REVIEW WAS DONE BY A RADIOLOGIST. ASSESSMENT OF IMAGING: NINE VIEWS OF THE RIGHT HIP DEMONSTRATE TWO VIEWS OF THE RIGHT HIP DATED (B)(6) 2021 DEMONSTRATING AN INTRAMEDULLARY ROD WITH TWO DYNAMIC FIXATION SCREWS WITHIN THE FEMORAL NECK FOR WHAT APPEARS TO BE AN INTERTROCHANTERIC HIP FRACTURE. SIMILAR APPEARANCE IS NOTED ON (B)(6) 2021. HOWEVER, THERE DOES APPEAR TO BE BACKING OUT OF THE SLEEVE PORTION OF BOTH SCREWS ON (B)(6) 2021 AND (B)(6) 2021. PRODUCT EVALUATION: NO PRODUCT WAS RETURNED; THEREFORE, VISUAL AND DIMENSIONAL EVALUATION COULD NOT BE PERFORMED. REVIEW OF PRODUCT DOCUMENTATION: DEVICE PURPOSE: ALL INVOLVED DEVICES ARE INTENDED FOR TREATMENT. PRODUCT COMPATIBILITY: THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET, ACCORDING TO SURGICAL TECHNIQUE. DHR REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. SURGICAL TECHNIQUE: THE CORRECT IMPLANTATION AND INSERTION (TLS PLACEMENT AND SET SCREW LOCKING) IS DESCRIBED IN THE SURGICAL TECHNIQUE. PLEASE ALSO NOTE THE FOLLOWING SECTION REGARDING SET SCREW LOCKING: AFTER THE TLS IS PLACED, THE PRE-ASSEMBLED SETSCREW IN THE NAIL MUST BE TIGHTENED WITH THE TORQUE LIMITING HANDLE OFFERED WITH THE SYSTEM, TO PREVENT THE TLS SLEEVE FROM MOVING POST-OPERATIVELY. AN ANTERIOR SUPPORT SCREW CAN BE PLACED IN ADDITION TO THE TLS TO PROVIDE ROTATIONAL STABILITY AND SUPPORT THE TREATMENT OF UNSTABLE INTERTROCHANTERIC FRACTURES WITH LARGE POSTEROMEDIAL (LESSER TROCHANTER) AND POSTEROLATERAL (GREATER TROCHANTER) FRAGMENTS, PREVENTING EXCESSIVE LAG SCREW SLIDING POST-OPERATION. CONCLUSION: IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH CM FORTIS SYSTEM ON (B)(6) 2021. ON NEXT DAY X-RAYS REVEALED THAT AS SCREW WAS BACKED OUT FROM THE IMPLANTED POSITION. AFTER ONE WEEK, TLS WAS ALSO BACKED OUT. IT WAS ALSO NOTICED THAT SLEEVE PART WAS BACKED OUT WITHOUT THE TELESCOPING PART SLIDING IN. NO REVISION SURGERY WAS PLANNED SO FAR. THE QUALITY RECORDS SHOW THAT ALL SPECIFIED CHARACTERISTICS (MATERIAL, DIMENSIONS, SURFACE, ETC.) FOR THE AFFECTED PRODUCTS HAVE MET THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. NO PRODUCT WAS RETURNED, HENCE VISUAL AND DIMENSIONAL EVALUATION COULD NOT BE PERFORMED; THEREFORE, THE CONDITION OF THE PARTS IS UNKNOWN. HOWEVER, THE RECEIVED X-RAYS CONFIRM THAT THE AS2 AND THE TLS WERE BACKED OUT POST-OPERATIVELY. BASED ON THE AVAILABLE INFORMATION IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE FOR THIS ISSUE. A FURTHER AND MORE COMPREHENSIVE INVESTIGATION IS UNDERGOING TO DETERMINE THE NECESSITY OF POTENTIAL CORRECTIVE AND/OR PREVENTIVE ACTIONS. ACCORDING TO THE CURRENT AVAILABLE INFORMATION, THERE ARE NO CONFIRMED PRODUCT NONCONFORMITY RELATED TO THE ISSUE. THERE ARE ALSO NO KNOWN DESIGN OR MANUFACTURING RELATED ISSUE TO THE ZNN CM FORTIS NAILS AND LAG SCREWS AT THIS TIME. A POSSIBLE CONTRIBUTING FACTOR FOR THE MIGRATION COULD BE A MALREDUCTION OR A REALLY UNSTABLE FRACTURE. BY CONSIDERING THESE FACTORS AND THE CORRESPONDING USE OF THE SYSTEM, GOOD RESULTS CAN BE EXPECTED EVEN IN THIS DEMANDING SITUATIONS. THIS IS ALSO CONFIRMED BY AN HCP REVIEW. IT IS ALSO MENTIONED THAT A MINOR BACKOUT OF THE TLS IS NOT A CLINICAL ISSUE. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER SWITZERLAND MANUFACTURING GMBH CONSIDERS THIS CASE AS CLOSED. ZIMMER BIOMET'S REFERENCE NUMBER OF THIS FILE IS (B)(4).
THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET WINTERTHUR AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET WINTERTHUR MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES. THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE PREVIOUS MEDWATCH. ADDITIONAL INFORMATION WAS RECEIVED ON SEP 03, 2021. ADDITIONAL: E1 CORRECTION: B4, G3, G6, H2, H10. THE MANUFACTURER RECEIVED OTHER SOURCE DOCUMENTS FOR REVIEW. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND / OR THE DEVICE(S) BE RETURNED FOR EVALUATION AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. ZIMMER¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).
NO EVENT UPDATE. INVESTIGATION RESULTS ARE NOW AVAILABLE.
PATIENT WAS IMPLANTED WITH CMF NAIL SYSTEM ON AN UNKNOWN SIDE. ONE WEEK POST IMPLANTATION, FROM THE X-RAY IT WAS OBSERVED THAT THE LAG SCREW WAS SLIDING TO THE OUTER SIDE FROM THE IMPLANTED POSITION. THE SURGEON IS MONITORING THE PATIENT'S CONDITION AND A REVISION SURGERY HAS NOT BEEN PLANNED.
THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET (B)(4) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET (B)(4) MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES. MEDICAL PRODUCTS: Z NAIL CMF 5.0X70 ANT SUP SCR; CATALOG#: 47-2501-070-50; LOT#: 3050774. Z NAIL CMF 11.5MMX17.5CM 125R; CATALOG#: 47-2498-180-11; LOT#: 3056778. Z NAIL CMF NAIL CAP 0MM; CATALOG#: 47-2500-002-00; LOT#: 3056973. 5.0 MM DIAMETER CORTICAL SCREW - RED FIXED ANGLE 3.5 MM HEX HEAD; CATALOG#: 47-2484-027-50; LOT#: 64997543. 5.0 MM DIAMETER CORTICAL SCREW - RED FIXED ANGLE 3.5 MM HEX HEAD; CATALOG#: 47-2484-027-50; LOT#: 65007835. THERAPY DATE: UNKNOWN. THE MANUFACTURER RECEIVED X-RAYS FOR REVIEW. OTHER DOCUMENTS WERE RECEIVED AND WILL BE REVIEWED AS PART OF ONGOING INVESTIGATION. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS SOON AS SUPPLEMENTAL INFORMATION BECOMES AVAILABLE AN UPDATED REPORT WILL BE SUBMITTED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).
PATIENT WAS IMPLANTED ON AN UNKNOWN SIDE WITH CM FORTIS SYSTEM. THE NEXT DAY X-RAYS REVEALED THAT AS SCREW WAS BACKED OUT FROM THE IMPLANTED POSITION. AFTER A WEEK, TLS HAD ALSO BACKED OUT. IT WAS ALSO NOTICED THAT SLEEVE PART WAS BACKED OUT WITHOUT THE TELESCOPING PART SLIDING IN. NO REVISION SURGERY HAS BEEN PLANNED YET.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 910296 | Z NAIL CMF 10.5 X 90 LAG SCR | TRAUMA PROSTHESIS | HWC | ZIMMER SWITZERLAND MANUFACTURING GMBH | N/A | 3054636 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 90 YR | Female | Hospitalization |