NA SD03.043.029Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982344342), received between Oct 1, 2024 and Apr 15, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 15, 2026Device-Device Incompatibility

  IT WAS REPORTED WHILE USING A TIBIAL NAIL ADVANCED BLACK JIG THE SCREW HOLES WERE NOT LINING UP. WHEN THE NURSE ATTACHED THE NAIL TO THE JIG, WE CHECKED THAT THE AIMING ARM WAS SECURE AND THAT THE SCREW HOLES WERE LINING UP USING THE TRIPLE SLEEVES AND THE LONG DRILL BIT. EVERYTHING WAS IN ORDER. AFTER THE SURGEON INSERTED THE NAIL, HE COMPLETED THE DISTAL LOCKING. WHEN HE WENT TO DO THE PROXIMAL LOCKING, THE DRILL BIT WOULD NOT GO THROUGH THE NAIL. WE CHECKED USING XRAY AND THE SCREW HOLES WERE VERY SLIGHTLY OFF WHAT THE JIG WAS AIMING AT. THIS CAUSED A DELAY TO THE SURGERY, AS THE SURGEON HAD TO FIND THE HOLES HIMSELF, WITHOUT USING THE JIG. THE SURGERY WAS DELAYED BY APPROXIMATELY 10 MINUTES. NEEDED TO BE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24887403 ↗
• MalfunctionFeb 17, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT CONNECT F/EXPERT HAN F/03.008.007, TNA CONNECTING TUBE TNA ARM, AND AIMING ARM ASSEMBLY TNA ARM WERE INVOLVED IN AN EVENT WHERE THE STRIKE CAP AND TNA CONNECTING TUBE BECAME WEDGED TOGETHER, MAKING IT IMPOSSIBLE FOR STAFF TO DISASSEMBLE THE DEVICES. ATTEMPTS TO REMOVE THE COMPONENTS PLACED SIGNIFICANT STRESS ON THE PATIENT, LEADING TO A CHANGE IN THE REMOVAL APPROACH. ALL THREE PIECES REMAINED STUCK TOGETHER AFTER THE PROCEDURE. THERE WAS NO REPORTED PATIENT CONSEQUENCE OR CLINICAL SYMPTOMS AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24365797 ↗
• MalfunctionFeb 10, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE AIMING ARM FOR TIBIA NAIL ADVANCED MISSED THE NAIL, SPECIFICALLY WITH A 9MM NAIL, RESULTING IN BOTH DEVICES MISSING THE PROXIMAL STATIC AND DYNAMIC HOLES. OVER X-RAY, THE AIMING ARM WAS OBSERVED TO COVER THE HOLES INTENDED FOR DRILLING, WHICH LED TO THE SURGEON PERFORMING PERFECT CIRCLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24309793 ↗
• MalfunctionJul 3, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A PROCEDURE, THE AIMING ARM FOR THE TIBIAL NAIL ADVANCED MISSED THE NAIL. TNA WAS WITH AN 8MM NAIL AND BOTH HAVE MISSED THE PROXIMAL STATIC AND DYNAMIC HOLES. OVER X-RAY, THE AIMING ARM WAS COVERING UP THE HOLES TO DRILL, ULTIMATELY RESULTING IN THE SURGEON DOING PERFECT CIRCLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22394744 ↗
• MalfunctionOct 1, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THERE WERE ISSUES WITH SOME DEVICES. THE AIMING ARM IS INTENDED TO BE USED TO TARGET THE SCREWS IN THE PROXIMAL PORTION OF THE NAIL. HOWEVER, THE AIMING ARM MISSED THE HOLE IN THE TNA NAIL. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS REPORT IS FOR AN AIMING ARM ASSEMBLY ROTATING TNA AIMING ARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20344642 ↗

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