Z NAIL CMF 10MMX21.5CM 125 R
Report
- Report Number
- 0009613350-2021-00408
- Event Type
- Malfunction
- Date Received
- August 16, 2021
- Date of Event
- August 4, 2021
- Report Date
- November 23, 2021
- 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 WINTERTHUR MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES. D10: MEDICAL PRODUCTS: Z NAIL CMF 5.0X85 ANT SUP SCR; CATALOG#: 47-2501-085-50; LOT#: 3050807; CMN ANTIROTATION PIN, THREADED, 3.0 MM, 320 MM; CATALOG#: 47-2490-320-30; LOT#: 3039430; Z NAIL CMF NAIL CAP 0MM; CATALOG#: 47-2500-002-00; LOT#: 3056988; 5.0 MM DIAMETER CORTICAL SCREW - RED FIXED ANGLE 3.5 MM HEX HEAD; CATALOG#: 47-2484-035-50; LOT#: 64923937; 5.0 MM DIAMETER CORTICAL SCREW - RED FIXED ANGLE 3.5 MM HEX HEAD; CATALOG#: 47-2484-042-50; LOT#: 64661205; Z NAIL CMF 11.5MM X 32CM 125 L; CATALOG#: 47-2498-321-11; LOT#: 3052633. THERAPY DATE: UNKNOWN. 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 AUG 18, 2021. 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).
INVESTIGATION RESULTS WERE MADE AVAILABLE. REVIEW OF EVENT DESCRIPTION: IT WAS REPORTED THAT THE PATIENT RECEIVED AN IMPLANT ON JUL 21, 2021. AFTER 2 WEEKS FROM THE INITIAL SURGERY, THE SURGEON FOUND THE LAG SCREW MIGRATED ON THE RADIOGRAPHICAL FOLLOW-UP. THE PATIENT IS BEING MONITORED, BUT NO REVISION SURGERY HAS BEEN 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: TWO UNDATED X-RAYS HAVE BEEN RECEIVED. THE FOLLOWING EVALUATION HAS BEEN PERFORMED BY HCP. THERE IS A GAP BETWEEN THE REDUCED FRAGMENTS INDICATING MALREDUCTION. THE TLS POSITION IS RATHER LOW. THE SLIDING LED TO CLOSURE OF THE GAP BETWEEN THE FRAGMENTS (FRACTURE STABILIZATION). PRODUCT EVALUATION: - THE DEVICES REMAIN IMPLANTED. 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 RELEVANT 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 RECEIVED AN IMPLANT ON JUL 21, 2021. AFTER 2 WEEKS FROM THE INITIAL SURGERY, THE SURGEON FOUND THE LAG SCREW MIGRATED ON THE RADIOGRAPHICAL FOLLOW-UP. THE PATIENT IS BEING MONITORED, BUT NO REVISION SURGERY HAS BEEN PLANNED SO FAR. THE QUALITY RECORDS SHOW THAT ALL SPECIFIED CHARACTERISTICS HAVE MET THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. THEREFORE, THE INVESTIGATION DID NOT IDENTIFY A NONCONFORMANCE OR A COMPLAINT OUT OF BOX (COOB). BASED ON THE RADIOGRAPHS, THE REPORTED SLIDING CAN BE CONFIRMED; HOWEVER, THE SLIDING RESULTED IN FRACTURE STABILIZATION OF THE INITIAL MALREDUCTION. NO PRODUCT WAS RETURNED, HENCE VISUAL AND DIMENSIONAL EVALUATION COULD NOT BE PERFORMED; THEREFORE, THE CONDITION OF THE PARTS IS UNKNOWN. BASED ON THE AVAILABLE INFORMATION IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE FOR THIS ISSUE. A FURTHER AND MORE COMPREHENSIVE INVESTIGATION WAS INITIATED 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. ADDITIONAL INFORMATION WHICH WAS RECEIVED ON SEP 03, 2021. THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE PREVIOUS MEDWATCH. 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).
PATIENT WAS IMPLANTED ON AN UNKNOWN SIDE. TWO WEEKS FROM THE INITIAL SURGERY, WITH THE HELP OF X-RAYS THE SURGEON NOTICED THAT THE LAG SCREW HAS MIGRATED. THE PATIENT IS BEING MONITORED AND A REVISION SURGERY HAS NOT YET BEEN PLANNED.
NO EVENT UPDATE. INVESTIGATION RESULTS ARE NOW AVAILABLE.
PATIENT WAS IMPLANTED ON AN UNKNOWN SIDE. TWO WEEKS FROM THE INITIAL SURGERY, WITH THE HELP OF X-RAYS THE SURGEON NOTICED THAT THE LAG SCREW HAS MIGRATED. THE PATIENT IS BEING MONITORED AND A REVISION SURGERY HAS NOT YET BEEN PLANNED.
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. MEDICAL PRODUCTS: Z NAIL CMF 5.0X85 ANT SUP SCR; CATALOG#: 47-2501-085-50; LOT#: 3050807. CMN ANTIROTATION PIN, THREADED, 3.0 MM, 320 MM; CATALOG#: 47-2490-320-30; LOT#: 3039430. 5.0 MM DIAMETER CORTICAL SCREW - RED FIXED ANGLE 3.5 MM HEX HEAD; CATALOG#: 47-2484-035-50; LOT#: 64923937. 5.0 MM DIAMETER CORTICAL SCREW - RED FIXED ANGLE 3.5 MM HEX HEAD; CATALOG#: 47-2484-042-50; LOT#: 64661205. Z NAIL CMF 11.5MM X 32CM 125 L; CATALOG#: 47-2498-321-11; LOT#: 305263. THERAPY DATE: UNKNOWN. THE MANUFACTURER RECEIVED X-RAYS FOR REVIEW. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR 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. TWO WEEKS FROM THE INITIAL SURGERY, WITH THE HELP OF X-RAYS THE SURGEON NOTICED THAT THE LAG SCREW HAS MIGRATED. THE PATIENT IS BEING MONITORED AND A REVISION SURGERY HAS NOT YET BEEN PLANNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1220320 | Z NAIL CMF 10MMX21.5CM 125 R | TRAUMA PROSTHESIS | HSB | ZIMMER SWITZERLAND MANUFACTURING GMBH | N/A | 3052824 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Hospitalization | SEE H10 NARRATIVE.| SEE H10 NARRATIVE. |