NA 04.045.034TSRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982302649), received between May 5, 2025 and Jun 16, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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.

• MalfunctionJun 16, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT OSTEOSYNTHESIS SURGERY FOR TROCHANTERIC FEMORAL FRACTURE WITH THE LOCKING SCREW. THE SURGEON USED THE LOCKING SCREW FOR THE SURGERY VIA TFNA, HOWEVER DUE TO A POOR FIT AND WOBBLY DRIVER WITH THE LOCKING SCREW, THE LOCKING SCREW DID NOT ENTER THE HOLE AFTER PRE-DRILLING AND SLID THROUGH THE BONE, CAUSING ABERRANT THE LOCKING SCREW TO ENTER THE BODY. THE INCISION WAS ENLARGED, AND THE ERRANT PARTS WERE REMOVED. THE PROVIDED PRODUCT WAS USED INSTEAD, AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22214602 ↗
• MalfunctionMay 5, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT THE ORIF SURGERY FOR FEMORAL SHAFT TUMOR WITH THE SCREWDRIVER AND THE LOCKING SCREW. AT THE TIME INSERTING THE DISTAL LOCKING SCREW AFTER USING SURELOCK FOR TFNA LONG NAIL, THE SURGEON ATTACHED THE ANS LOCKING SCREW (5.0MM) USING THE SCREWDRIVER (T25). HOWEVER, THERE WAS A GAP BETWEEN TIP OF THE SCREWDRIVER AND THE SCREWHEAD, AND NO GRIPPING FORCE AT ALL. THE INSERTION WAS COMPLETED WITH NO PROBLEM, BUT IT MIGHT CAUSE STRIPPING THE SCREWHEAD. THE SALES REP FELT THAT TIP OF THE SCREWDRIVER WAS ONE ROUND SMALLER THAN THE SCREWHEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21962765 ↗

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