NA 04.045.334Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982293534), received between Sep 6, 2022 and Jan 23, 2024 — classified as 1 injury, 1 malfunction.

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

2 other recalls cover devices cleared under the same FDA submission (K201336, K201346); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 23, 2024Break; Break

  (B)(4) IS CREATED TO CAPTURE THE POST OP EVENT STATING THAT, IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT CAME IN FOR A REVISION SURGERY OF A NONUNION OF A PROXIMAL THIRD TIBIA FRACTURE. PRIMARY SURGERY WAS TREATED WITH A TIBIAL NAIL ADVANCED. SURGEON REMOVED THE TIBIAL NAIL AND 4 LOW PROFILE INTERLOCK SCREWS. ONE OF THE PROXIMAL SCREWS WAS BROKEN. (B)(4) WAS FOR THE INTRA OP EVENT: SURGEON OPTED TO USE A RIA2 FOR BONE GRAFTING, WHICH WAS TAKEN FROM THE FEMUR. INITIALLY THERE WAS AN ISSUE WITH SUCTION OCCURRING THROUGH THE RIA2. RIA2 PARTS WERE DISSEMBLED AND PUT BACK TOGETHER. THERE WAS STILL SOME ISSUE WITH WATER SPRAYING OUT THE BACK END OF THE RIA2 SHAFT. SURGEON OPTED TO CONTINUE WITH PROCEDURE TO GET BONE GRAFT. WHILE REAMING THE REAMER HEAD BROKE OFF IN THE PATIENTS FEMORAL CANAL, THE 4 PRONGS THAT ATTACH THE REAMER HEAD TO THE SHAFT WERE RETAINED IN THE PATIENT. AFTER DISASSEMBLING THE RIA2 AFTER THE CASE, IT WAS NOTED THAT THE YELLOW KEYED SEAL DID NOT HAVE ANY BLACK SEAL ON IT. THE SECOND YELLOW SEAL INCLUDED IN THE PACKAGE ALSO DID NOT HAVE A BLACK SEAL. THE RIA2 OBTAINED SOME GRAFT, BUT SURGEON HAD TO ALSO GET BONE GRAFT FROM THE PROXIMAL TIBIA. ADDITIONAL XRAYS, AD

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 18565686 ↗
• MalfunctionSep 6, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2022 AT THE TIME OF USING A TIBIAL NAIL AND ONE OF THE LOCKING SCREWS MISSED THE NAIL THROUGH AIMING JIG. THERE WAS SURGICAL DELAY DUE TO THE REPORTED EVENT BUT THE SURGERY WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS NORMAL. THIS REPORT IS FOR ONE (1) LOW PROF LCKNG SCR 5.0 / L 34 / XL25 THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15361452 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K201336, K201346. One submission often covers many models, so check the product and lot details in each record.

• 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
• 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