UNKNOWN RFN NAIL
Report
- Report Number
- 0001822565-2025-03729
- Event Type
- Injury
- Date Received
- October 15, 2025
- Date of Event
- December 20, 2017
- Report Date
- March 18, 2026
- Manufacturer
- ZIMMER BIOMET, INC.
- Product Code
- HSB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4): THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, G3, G6, H2, H11. THE FOLLOWING SECTIONS WERE CORRECTED: B3, B5, D6B. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: B4; B5; B7; D2; D4; G1; G3; G6; H1; H2; H3; H6. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. MEDICAL RECORDS WERE NOT PROVIDED. DEVICE HISTORY RECORD REVIEW CANNOT BE PERFORMED WITHOUT PRODUCT IDENTIFICATION. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE COMPLAINT WAS NOT CONFIRMED. IF ANY FURTHER INFORMATION WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
(B)(4). E1: ESTABLISHMENT NAME: (B)(6). G2: FOREIGN: UNITED KINGDOM. H3: CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT LOCATION IS UNKNOWN. H6: COMPONENT CODES: MECHANICAL (G04)- IM NAIL. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
IT WAS REPORTED THAT A PATIENT WITH A SPIRAL FEMORAL FRACTURE TREATED WITH A RETROGRADE INTRAMEDULLARY NAIL DURING THE PRIMARY PROCEDURE PERFORMED. THE FRACTURE WAS NOT FULLY REDUCED AT THE TIME OF THE PRIMARY SURGERY, RESULTING IN A PERSISTENT FRACTURE GAP. AT FOLLOW-UP ASSESSMENTS AT 8 WEEKS AND 12 WEEKS POST-OPERATIVELY, NO RADIOGRAPHIC EVIDENCE OF CALLUS FORMATION WAS OBSERVED, RAISING CONCERN FOR PROGRESSION TOWARD NON-UNION. A CLINICAL DECISION WAS MADE TO PERFORM A REVISION PROCEDURE TO FACILITATE FRACTURE HEALING. REVISION SURGERY CONSISTING OF INTRAMEDULLARY NAIL REVISION WITH BONE GRAFTING AND CABLE FIXATION WAS PERFORMED APPROXIMATELY 3 MONTHS AND 26 DAYS POST IMPLANTATION. SUBSEQUENT FOLLOW-UP DEMONSTRATED RADIOGRAPHIC SIGNS OF FRACTURE HEALING. THE PATIENT WAS LATER LOST TO FOLLOW-UP, AND THE FINAL CLINICAL OUTCOME THEREFORE REMAINS UNKNOWN. THE EVENT WAS ASSESSED AS CAUSALLY RELATED TO THE SURGICAL PROCEDURE AND NOT RELATED TO THE DEVICE OR THE INSTRUMENTATION. ATTEMPT HAS BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED AT THIS TIME.
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL IMPLANTATION APPROXIMATELY NINE (9) YEARS AGO AS PART OF A PMCF STUDY ON THE AFN AND RFN ZNN (ZIMMER NATURAL NAILS) AFTER EXPERIENCING A SPIAL FRACTURE TREATED BY RETROGRADE NAIL. IT WAS NOTED THAT DURING THE PRIMARY PROCEDURE, THE FRACTURE WAS NOT FULLY REDUCED AND THERE WAS A GAP BETWEEN FRACTURE FRAGMENTS. DURING THE PATIENT'S 8-WEEK FOLLOW UP AND 12-WEEK FOLLOW UP, THERE WAS NO CALLUS SEEN IN THE FRACTURE SITE. DURING THE 12-WEEK FOLLOW UP, THERE WAS A CONCERN THAT FRACTURE WAS LIKELY HEADING TO NON-UNION AND THE SURGEON MADE THE DECISION THAT ANOTHER SURGICAL PROCEDURE TO FACILITATE FRACTURE HEALING WOULD BE NEEDED. THE PATIENT UNDERWENT A REVISION APPROXIMATELY FOUR (4) MONTHS POST-IMPLANTATION WITH INTRAMEDULLARY NAILING WITH BONE GRAFTING AND CABLE FIXATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL SURGERY APPROXIMATELY EIGHT (8) YEARS AND TWO MONTHS AGO. SUBSEQUENTLY, APPROXIMATELY THREE (3) MONTHS AFTER THE INITIAL SURGERY THE PATIENT WAS REVISED AS THE PATIENT'S BONE HAD NOT HEALED AND THERE WAS CONCERN OF A NON-UNION DEVELOPING. ATTEMPT HAS BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 594696 | UNKNOWN RFN NAIL | IMPLANT TRAUMA | HSB | ZIMMER BIOMET, INC. | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 18 YR | Male | Required Intervention| H |