NA 04.045.032SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982294388), received between Jan 13, 2023 and Jun 2, 2025 — classified as 3 malfunctions.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 2, 2025Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT ORIF SURGERY FOR FEMORAL SHAFT FRACTURE WITH THE LOCKING SCREW. THE SURGEON ATTACHED THE LOCKING SCREW TO THE SCREWDRIVER (03.045.003) AND THE RETENTION PIN (03.045.004) AND TRIED TO INSERT THE LOCKING SCREW. WHILE INSERTING THE LOCKING SCREW, THE SURGEON HEARD CRACK SOUND. SO, THE SURGEON REMOVED THE LOCKING SCREW AND CHECKED ACTUAL PRODUCT, IT WAS CONFIRMED THAT THE TIP OF THE RETENTION PIN WAS BROKEN AND LEFT IN THE SCREWHEAD. THE SURGEON GAVE UP USING THE LOCKING SCREW IN QUESTION AND USED DIFFERENT SCREW INSTEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22125248 ↗
• MalfunctionOct 23, 2023No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PHYSICIAN REPORTED THAT A SHORT RFNA WHICH HE HAD IMPLANTED ON (B)(6) 2022 HAD BROKEN AT THE JUNCTION BETWEEN THE MOST DISTAL SCREW OF THE PROXIMAL INTERLOCKING SCREWS. THE SURGEON REMOVED THE BROKEN HARDWARE ON (B)(6) 2022 AND REVISED THE CONSTRUCT WITH A NAIL AND PLATE. UPON PRODUCT RETURN TO THE MANUFACTURER AND EXAMINATION ON OCTOBER 11, 2023, IT WAS IDENTIFIED THAT TWO SCREWS WERE STRIPPED. THIS REPORT INVOLVES ONE LOCKING SCREW FOR IM NAIL Ø 5MM/ 32MM/ XL25/ STERILE. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17984193 ↗
• MalfunctionJan 13, 2023Device-Device Incompatibility; Device-Device Incompatibility

  THE SURGEON CONFIRMED BY X-RAY THAT THERE WERE NO PIECES LEFT IN THE PATIENT. IT WAS FURTHER ADDED THAT THERE WAS A MARK IN FRONT OF THE RETENTION PIN PROHIBITING HAMMERING. NO WARNING IN THE PROCEDURE MANUAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16158776 ↗

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 Adva
• 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 Adva