NA 04.045.334TSRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982301352), received between Apr 3, 2026 and Sep 24, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (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.

• MalfunctionSep 24, 2026Manufacturing, Packaging or Shipping Problem

  It was reported the surgeon had some difficulty determining the correct screw length to use during a procedure. The surgeon originally inserted a 34mm Screw but imaging showed it was too long. After removing the Screw it measured 46mm. Two 40mm Screws were opened and manually measured as 38mm. Ultimately the surgeon opened and implanted a 42mm Screw. The procedure was completed with a thirty (30) minute delay and no harm to the person.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50884580 ↗
• InjuryApr 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2026 THE PATIENT UNDERWENT A REVISION/REMOVAL AND REPLACEMENT IMPLANTS DUE TO NONUNION/MALUNION ORIF TIBIA. THE ORIGINAL NAIL WAS REMOVED, AN OSTEOTOMY WAS PERFORMED TO CORRECT THE DEFECT IN THE PROXIMAL TIBIA, THE REPLACEMENT NAIL WAS THEN IMPLANTED USING TWO PROXIMAL INTERLOCKS. THE NAIL CONSTRUCT WAS SUPPLEMENTED BY A COMPETITOR LATERAL PROXIMAL TIBIA PLATE. ON (B)(6) 2026 PATIENT AGAIN UNDERWENT THE REMOVAL PROCEDURE DUE TO A LOOSE SCREW FROM A TNA. WHEN TAKING OUT THE PROTRUDING SCREW, IT WAS DISCOVERED THAT THE SECOND INTERLOCK WAS ALSO BROKEN. THIS REPORT CAPTURES THE FIRST REVISION SURGERY PERFORMED ON (B)(6) 2026 DUE TO NONUNION/MALUNION WHILE RELATED COMPLAINT PC-002117597 CAPTURES THE SECOND REMOVAL SURGERY PERFORMED ON (B)(6) 2026 DUE TO TWO (2) LOOSE/BROKEN PROXIMAL INTERLOCKING SCREWS.

  Patient problems: Malunion of Bone; Nonunion/Delayed-union Bone Fracture

  MAUDE report 24779816 ↗

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