NA 04.043.350SRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982298263), received between Aug 7, 2023 and Aug 29, 2025 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (K201336); they may or may not involve this specific model.

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryAug 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT THE INITIAL TIBIA NAIL SURGERY WITH INSERTION OF 9MM DIAMETER NAIL. THIS BECAME A NONUNION WITH TIBIA NAIL EXCHANGE TO 11MM DIAMETER.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 22921879 ↗
• InjuryAug 21, 2025Break; Break

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE TWO PROXIMAL SCREWS DID BREAK. I WAS UNABLE TO OBTAIN THOSE FOR RETURN. BOTH WERE POSITIONED IN THE TRANSVERSE LOCKING POSITIONS.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 22866596 ↗
• MalfunctionMar 26, 2024Use of Device Problem; Detachment of Device or Device Component; Device-Device Incompatibility; Material Deformation; Use of Device Problem; Detachment of Device or Device Component; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THERE WAS NO SURGICAL DELAY. THE TIBIAL NAIL ADVANCED WITH THE POLY INLAY BECAME LOOSE.

  Patient problems: Insufficient Information

  MAUDE report 18979286 ↗
• MalfunctionFeb 12, 2024Device Slipped; Detachment of Device or Device Component; Device Slipped; Detachment of Device or Device Component

  UNSURE WHAT CAUSED THE PROBLEM INITIALLY. THE POLYMER INLAY COULD HAVE BEEN LOOSE BEFORE THE INSERTION OF THE REAMING ROD, OR THE REAMING ROD COULD HAVE MADE THE POLY INLAY LOOSE.  FRAGMENTS WERE GENERATED, BUT THEY WERE NOT EASILY RETRIEVED, AND FRAGMENTS WERE NOT IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18687894 ↗
• MalfunctionAug 7, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2023, DURING AN UNKNOWN PROCEDURE THE PEEK INLAY SHIFTED BY THE PROXIMAL PORTION OF THE NAIL. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A TIBIAL NAIL-ADVANCED / 11MM 390MM / STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17472349 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K201336. One submission often covers many models, so check the product and lot details in each record.

• Z-0228-2026 · Sep 26, 2025 · Open, Classified
  LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 46MM / XL25/ STER. Product Code: 04.045.346TS. Used in RFN-ADVANCEDTM Retrograde Femoral Nailing (RFNA) System and the Tibial Nail A
• Z-0229-2026 · Sep 26, 2025 · Open, Classified
  LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 42MM / XL25/ STER. Product Code: 04.045.342TS. Used in RFN-ADVANCEDTM Retrograde Femoral Nailing (RFNA) System and the Tibial Nail A