NA 214.846Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982154729), received between Oct 20, 2022 and Sep 4, 2026 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 4, 2026Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50616504 ↗
• InjuryJul 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHESE REPORTS AN EVENT IN COLUMBIA AS FOLLOWS: IT WAS REPORTED A REVISION SURGERY OCCURRED ON AN UNKNOWN DATE IN JUNE 2023. THE TECHNICAL ASSISTANT PERFORMED THE PRE-OPERATIVE PLAN WITH THE SURGEON, WHICH WAS NOTED AS "THE PLAN IS TO REMOVE THE MEDIAL PLATE. THE LATERAL PLATE WILL BE LEFT. ONLY THE DISTAL SCREWS ARE TO BE RELEASED. THE OSTEOTOMY WILL BE PERFORMED, AND THE INSERT WILL BE PLACED TO CORRECT THE PSEUDOARTHROSIS". DURING THE PROCEDURE THE MEDIAL PLATE WAS REMOVED AND THEN THE DISTAL SCREWS OF THE LATERAL PLATE WERE REMOVED, BUT THE PLATE WAS NOT REMOVED. OSTEOTOMY WAS PERFORMED AND THE INSERT WAS PLACED, THEN PROCEEDED TO FIX THE PLATE USING NEW SCREWS FROM J&J. IT SHOULD BE NOTED THAT 2 INTERFRAGMENTARY COMPRESSION SCREWS WERE ALSO PLACED. THE PROCEDURE ENDED WITHOUT ANY NOVELTY AND WITH TOTAL NORMALITY. THE PLATE IMPLANTED IN THE PATIENT WAS FROM ANOTHER BRAND, AND THE SCREWS TO FIX THIS PLATE ARE FROM J&J. ORIGINAL IMPLANT DATE WAS NOT NOTED. THIS IS FOR ONE (1) 4.5MM CORTEX SCREW SELF-TAPPING 46MM FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 17247721 ↗
• InjuryApr 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED. ON (B)(6) 2020, AN X-RAY OF FEMUR REPORT AND REVEALED A CLOSED COMMINUTED SUPRACONDYLAR FRACTURE OF LEFT FEMUR WITH NONUNION. DOI: (B)(6) 2019; DOE: (B)(6) 2020; LEFT FEMUR. THIS REPORT IS FOR A 4.5MM CORTEX SCREW SELF-TAPPING 46MM. THIS IS REPORT 7 OF 14 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 16724066 ↗
• InjuryOct 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS SUBMITTED AS PART OF AN INVESTIGATOR INITIATED STUDY (IIS) FOR THE RETROGRADE FEMORAL NAIL ADVANCED (RFNA). IT WAS REPORTED THAT A PATIENT WAS PRESENTED AFTER A MOTOR VEHICLE CRASH WITH A LEFT OPEN DISTAL FEMUR FRACTURE ON (B)(6) 2021 AND WAS OPERATED ON WITH RFNA INTRAMEDULLARY NAIL ON (B)(6) 2021. PATIENT WAS DIAGNOSED WITH INFECTION OF HER HARDWARE/SEPTIC NONUNION ON (B)(6) 2021. PATIENT UNDERWENT DEBRIDEMENT AND EXCHANGE OF HARDWARE ON (B)(6) 2021. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) 4.5MM CORTEX SCREW SELF-TAPPING 46MM THIS IS REPORT 8 OF 8 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture; Unspecified Infection

  MAUDE report 15643872 ↗