Z NAIL CMF 13MMX21.5CM 130 L
Report
- Report Number
- 0009613350-2021-00627
- Event Type
- Malfunction
- Date Received
- December 1, 2021
- Date of Event
- November 1, 2021
- Report Date
- January 12, 2022
- Manufacturer
- ZIMMER SWITZERLAND MANUFACTURING GMBH
- Product Code
- HSB
- 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
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 (B)(4) MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES. MEDICAL PRODUCT: 5.0 MM DIAMETER CORTICAL SCREW - RED FIXED ANGLE 3.5 MM HEX HEAD; CATALOG#: 47-2484-027-50; LOT#: 65042898; 5.0 MM DIAMETER CORTICAL SCREW - RED FIXED ANGLE 3.5 MM HEX HEAD; CATALOG#: 47-2484-030-50; LOT#: 64922871; Z NAIL CMF NAIL CAP 0MM; CATALOG#: 47-2500-002-00; LOT#: 3059715; Z NAIL CMF 5.0X70 ANT SUP SCR; CATALOG#: 47-2501-070-50; LOT#: 3050805. THE MANUFACTURER RECEIVED X-RAYS WHICH WILL BE REVIEWED AS PART OF ONGOING INVESTIGATION. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. THE LOT NUMBER OF THE DEVICE WAS RECEIVED. THE DEVICE HISTORY RECORDS WILL BE REVIEWED DURING INVESTIGATION. 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). THE FOLLOWING REPORTS ARE ASSOCIATED WITH THIS EVENT: 0009613350-2021-00626.
INVESTIGATION RESULTS WERE MADE AVAILABLE. 1. EVENT DESCRIPTION: IT WAS REPORTED THAT: INITIAL OPERATION WAS PERFORMED WITH CMF NAIL SYSTEM ON (B)(6) 2021. AFTER 4 WEEKS FROM THE INITIAL, SURGEON CONFIRMED X-RAYS AND HE FOUND THE LAG SCREW WAS SLIDING TO OUTER SIDE. THE SURGEON KEEPS AN EYE ON THE PATIENT CONDITION AS WELL AS NO REVISION WILL BE PLANNED SO FAR. HARM: S2 - INSTABILITY, MINOR. HAZARDOUS SITUATION: IMPLANT DETERIORATES, BREAKS OR LOSES FUNCTION POSTOPERATIVELY. 2. 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: TWO X-RAY PICTURES HAVE BEEN RECEIVED. THE X-RAYS CONFIRM THAT THE LAG SCREW WAS SLIDING TO OUTER SIDE. 3. PRODUCT EVALUATION: NO PRODUCT WAS RETURNED; THEREFORE, VISUAL AND DIMENSIONAL EVALUATION COULD NOT BE PERFORMED. 4. REVIEW OF PRODUCT DOCUMENTATION: DEVICE PURPOSE: ALL INVOLVED DEVICES ARE INTENDED FOR TREATMENT. PRODUCT COMPATIBILITY: THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET, DHR REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. SURGICAL TECHNIQUE SAP: REVIEW 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. 5. CONCLUSION: IT WAS REPORTED THAT: INITIAL OPERATION WAS PERFORMED WITH CMF NAIL SYSTEM ON (B)(6) 2021. AFTER 4 WEEKS FROM THE INITIAL, SURGEON CONFIRMED X-RAYS AND HE FOUND THE LAG SCREW WAS SLIDING TO OUTER SIDE. THE SURGEON KEEP AN EYE ON THE PATIENT CONDITION AS WELL AS NO REVISION WILL BE 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). THE FOLLOWING REPORTS ARE ASSOCIATED WITH THIS EVENT: 0009613350-2021-00626-1.
IT WAS REPORTED THAT AFTER INITIAL SURGERY WAS PERFORMED THERE WAS NOTICED THAT THE LAG SCREW HAS MIGRATED.
INVESTIGATION RESULTS ARE NOW AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1804577 | Z NAIL CMF 13MMX21.5CM 130 L | TRAUMA PROSTHESIS | HSB | ZIMMER SWITZERLAND MANUFACTURING GMBH | N/A | 3057762 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Female |