NA 04.045.036TSRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982302656), received between Aug 29, 2025 and Mar 2, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Material Twisted/Bent” (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.

• MalfunctionMar 2, 2026Material Twisted/Bent

  IT WAS REPORTED THAT ON(B)(6) 2026, THE PATIENT UNDERWENT AN UNKNOWN SURGERY. BEFORE INSERTING THE SCREW IN QUESTION, THE SURGEON TRIED TO ATTACH IT TO THE SCREWDRIVER, BUT IT DID NOT FIT PROPERLY EVEN HE/SHE PRESSED THE SCREW AGAINST THE SCREWDRIVER. FURTHERMORE, WHEN THE SCREWDRIVER WAS TURNED WHILE THE SCREW WAS ATTACHED, ONLY THE SCREWDRIVER SPUN FREELY. IT WAS DECIDED THAT THE SCREW WAS NOT IN A CONDITION TO BE USED, AND SINCE THERE WAS A HIGH POSSIBILITY OF CAUSING TROUBLE WHILE INSERTION, THE SURGEON USED ANOTHER SCREW (04.045.038TS), WHICH IS 2 MM LONGER THAN THE SCREW IN QUESTION. 04.045.038TS COULD BE ATTACHED TO THE SCREWDRIVER WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN A 30-MINUTE DELAY. SINCE IT WAS NOTICED BEFORE INSERTION, THERE WAS NO EFFECT ON THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24482007 ↗
• 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 22921890 ↗

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