NA 04.045.038TSRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982302663), received between Jul 7, 2025 and Sep 30, 2026 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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

• MalfunctionSep 30, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951283 ↗
• MalfunctionFeb 19, 2026Break; Entrapment of Device

  IT WAS REPORTED DURING A PROCEDURE ON (B)(6) 2026, THE SCREW BROKE WHEN THE SURGEON OVER TORQUED THE SCREWDRIVER. THE SURGEON WAS TRYING TO GET THE SCREW FLUSH WITH THE PATIENT¿S THICK BONE. THE HEAD WAS REMOVED AND THE SHAFT WAS LEFT IN THE PATIENT¿S BONE. THE SURGEON WAS OKAY WITH THIS.

  Patient problems: Foreign Body In Patient

  MAUDE report 24392876 ↗
• 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 22921899 ↗
• MalfunctionJul 7, 2025Material Deformation; Material Integrity Problem; Material Deformation; Material Integrity Problem

  IT WAS REPORTED THAT THE PLASTIC TUBE OUTER CASING OF THE STERILE TUBED SCREW WAS DAMAGED AND DEFORMED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22410620 ↗

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-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