NA 04.043.125SRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886982297617), received between Jul 14, 2022 and Dec 13, 2024 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (4 reports).

2 other recalls cover devices cleared under the same FDA submission (K201336); 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 13, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024 THE 2.5MM BALL TIP GUIDE WIRE BECAME LODGED IN THE NAIL AND WAS NOT ABLE TO BE REMOVED. THE NAIL WAS REMOVED TO SEE THAT THE POLYMER HAS MIGRATED UP THE NAIL AND CAUSED IT TO BIND UP IN THE CANNULATION. BOTH THE T-HANDLE CHUCK AND IMPACTION TOOL WERE DAMAGED AND BROKEN INTO MULTIPLE PIECES DURING THE REMOVAL PROCESS. THE NAIL WAS REMOVED AND AN ALTERNATE NAIL WAS OPENED TO PROCEED ON WITH THE SURGERY. NO HARM WAS DONE TO THE PATIENT AND SURGICAL TIME WAS NOT EXTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20924891 ↗
• InjuryApr 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT INITIAL PROCEDURE ON (B)(6) 2023 AND WAS IMPLANTED WITH TIBIAL NAIL ADVANCED AND SCREWS TO TREAT RIGHT TIBIAL SHAFT FRACTURE. ON (B)(6) 2024, THE PATIENT UNDERWENT IMPLANT REMOVAL PROCEDURE DUE TO PAIN. PATIENT OUTCOME IS REPORTED AS RECOVERED WITHOUT PERSISTENT DAMAGE. THIS REPORT IS FOR ONE (1) TIBIAL NAIL-ADVANCED / 9MM 315MM / STERILE. THIS IS REPORT 1 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: Pain

  MAUDE report 19027888 ↗
• InjuryFeb 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY ID: (B)(6). SUBJECT ID: (B)(6). IT WAS REPORTED THAT A LEFT FEMUR NONUNION OCCURRED. THIS REPORT IS FOR ONE (1) TIBIAL NAIL-ADVANCED / 9 315 / STERILE. THIS IS REPORT 1 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 18715078 ↗
• MalfunctionSep 30, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON UNKNOWN DATE UPON TRYING TO LOCK THE NAIL PROXIMAL, THE LONG 4.2 DRILL BIT WAS HITTING THE NAIL ON THE S2 HOLE. SURGEON MOVED TO THE S1 HOLE AND IT AGAIN WAS HITTING THE NAIL. THE CONNECTING SCREW WAS RE-TIGHTEN IN THE NAIL, BUT IT STILL DIDN¿T WORK. THE SURGEON'S TEAM TOOK A LATERAL VIEW AND IT APPEARED TO BE HITTING THE NAIL ANTERIOR ON S2 AND POSTERIOR ON S1. THE SURGEON REMOVED THE INNER 4.2 SLEEVE AND WAS ABLE TO FREE HAND THE DRILL INTO THE HOLE. IT WAS ABOUT A 5 MINUTE DELAY. SURGERY WAS COMPLETED SUCCESSFULLY. THIS COMPLAIN INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) TIBIAL NAIL-ADVANCED / 9 315 / STERILE THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15521765 ↗
• MalfunctionSep 24, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2022, DURING AN OPEN REDUCTION/INTERNAL FIXATION OF THE TIBIA PROCEDURE, THE PROXIMAL AND DISTAL TNA POLY INLAYS MIGRATED SUPERIORLY AND ROTATED WHEN PASSED OVER THE BALL TIP REAMING WIRE. THE SURGEON USED A TONSIL CLAMP TO REPOSITION BOTH INLAYS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A 2-MINUTE DELAY AS A RESULT OF THE EVENT. THIS REPORT INVOLVES ONE TIBAL NAIL-ADVANCED / 9MM 315MM / STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15481342 ↗
• MalfunctionAug 22, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2022, THE NAIL WAS BEING INSERTED OVER A SMOOTH 3.0 GUIDEWIRE LIKE USUAL AND THE WIRE SEEMED TO GET CAUGHT UP IN THE POLY IN THE PROXIMAL PART OF THE NAIL. IT CLEARLY DAMAGED THE POLY AND WE HAD TO TAKE THE NAIL OUT AND USE A DIFFERENT NAIL. NEW NAIL INSERTED WAS THE SAME SIZE NAIL. NO FRAGMENTS WERE GENERATED. NAIL IS AVAILABLE FOR RETURN. UPON INSERTION OF THE NEW NAIL THE DRILL BIT WAS MISSING THE STATIC HOLE SO WE HAD TO TAKE OFF THE AIMING ARM AND DO PERFECT CIRCLES IN ORDER TO GET THE BOLTS IN THE NAIL. THE SURGERY WAS COMPLETED SUCCESSFULLY. NO OTHER PATIENT INFO AT THIS TIME. CONCOMITANT DEVICE REPORTED: UNK - DRILL BITS: TRAUMA. THIS REPORT IS FOR ONE (1) TIBIAL NAIL-ADVANCED / 9 315 / STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15264469 ↗
• InjuryJul 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, THE REMOVAL AND REVISION OF TIBIAL NAIL AND THE UNKNOWN SCREW. PATIENT OUTCOME WAS THERE. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR (1) TIBIAL NAIL-ADVANCED / 9 315 / STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 15012188 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K201336. 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