NA 03.233.006Recalls & reported problems

Summary

The FDA's MAUDE database contains 71 adverse event reports that list this exact device (DI 10886982288363), received between Apr 8, 2021 and Aug 28, 2026 — classified as 71 malfunctions.

The most frequently reported specific device problem is “Break” (46 reports).

2 other recalls cover devices cleared under the same FDA submission (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 25 most recent of 71 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 28, 2026Use of Device Problem

  It was reported a piece of the device was lost in sterilization process of RFNA aiming arm. Product cannot be used without it. No patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50503352 ↗
• MalfunctionAug 19, 2026Device-Device Incompatibility

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50328896 ↗
• MalfunctionJul 1, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A CASE ON (B)(6) 2026 THE TARGETED DISTAL LOCKERS ON THE RFNA AIMING ARM WERE NOT ALIGNING PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25680911 ↗
• MalfunctionJun 9, 2026Break

  IT WAS REPORTED THAT A RADIOLUCENT AIMING ARM WAS BROKEN DURING A TIBIAL NAIL CASE. THE AIMING ARM WAS BROKEN JUST AFTER STERILIZATION. THE PIECE WAS BROKEN WHEN IT WAS BEING TAKEN OFF. THERE WAS NO PATIENT HARM OR ISSUES TO THE PATIENT. THERE WAS NO SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25448560 ↗
• MalfunctionJun 4, 2026Break; Device Slipped

  IT WAS REPORTED ON (B)(6) 2026, THAT SURGEON WAS INSERTING THE RETROGRADE NAIL INTO THE FEMORAL CANAL. THE AIMING ARM WAS CONNECTED TO THE INSERTION HANDLE DURING NAIL INSERTION. THEIR WAS A TIGHT FIT OF THE NAIL IN THE FEMORAL CANAL THAT REQUIRED FORCE WHEN DELIVERING THE MALLET ON THE DRIVING CAP. DURING IMPACTION, THE MECHANISM THAT ATTACHES THE AIMING ARM TO THE INSERTION HANDLE WAS KNOCKED LOOSE, CAUSING THE AIMING ARM TO PERMANENTLY DISCONNECT FROM THE INSERTION HANDLE. THEY HAVE TWO INSTRUMENT SETS AND A SECOND SET WAS OPENED AND SUCCESSFULLY UTILIZED. THE DELAY IN THE CASE WAS MINIMAL, ONLY REQUIRING THE TIME TO LOCATE AND OPEN THE SECOND INSTRUMENT SET. THE CASE WAS SUCCESSFULLY COMPLETED. THE BROKEN AIMING ARM NEEDS REPLACED ASAP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25390899 ↗
• MalfunctionApr 7, 2026Crack; Material Deformation

  IT WAS REPORTED THAT THE AIMING ARM IS CRACKED AND ONE ARM IS BENT. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24801779 ↗
• MalfunctionMar 5, 2026Break

  IT WAS REPORTED THE AIMING ARM HOOK BROKE OFF THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24521386 ↗
• MalfunctionFeb 6, 2026Break

  IT WAS REPORTED THAT A RETROGRADE ARM BROKE DURING DISASSEMBLY. THERE WAS NO SURGICAL DELAY AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24277968 ↗
• MalfunctionJan 5, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT DURING DEMONSTRATION OF THE JIG TO A NEW SCRUB TECH, A RFNA AIMING JIG DID NOT LINE UP WITH THE NAIL. IT WAS UNABLE TO DETERMINE IF AIMING JIG/INSERTION HANDLE/CONNECTION SCREW ARE THE CAUSE. IT MAY HAVE BEEN DAMAGED IN SPD OR IN CASE. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23958913 ↗
• MalfunctionOct 15, 2025Break; Break

  IT WAS REPORTED THAT ON (B)(6), 2025, HOSPITAL STAFF WAS OPENING STERILE SETS TO PREPARE FOR A CASE FOR A RETROGRADE FEMORAL NAIL. THE SYNTHES RFNA BASE NAIL SET WAS OPENED FROM THE STERILE WRAPPING AND PLACED ONTO THE STERILE FIELD. AS THE SCRUB TECH WAS PREPARING INSTRUMENTATION FOR THE CASE, THEY NOTICED THAT THE AIMING ARM FOR THE RFNA NAIL SYSTEM WAS BROKEN. UPON FURTHER INSPECTION, ONE OF THE AIMING ARM CLIPS THAT ATTACHES TO THE INSERTION HANDLE HAD BEEN BROKEN OFF. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23279076 ↗
• MalfunctionAug 4, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, BOTH RFNA AIMING ARMS GET ¿STUCK¿ ON INSERTION HANDLE AND ARE DIFFICULT TO REMOVE. BOTH NEED TO BE REPLACED. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22709702 ↗
• MalfunctionAug 4, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, BOTH RFNA AIMING ARMS GET ¿STUCK¿ ON INSERTION HANDLE AND ARE DIFFICULT TO REMOVE. BOTH NEED TO BE REPLACED. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22709675 ↗
• MalfunctionJul 8, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE AIMING ARM SEEMED TO BE GETTING STUCK TO CONNECTING SCREW AND WOULD NOT COME APART VERY EASILY. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22437647 ↗
• MalfunctionMay 7, 2025Break; Break

  IT WAS REPORTED THAT THE AIMING ARM FROM ONE OF THE RFNA SET BROKE WHEN SURGEON TRIED TO ROTATE THE NAIL INTRA-OPERATIVELY. CASE WAS COMPLETED WITH NO ADDITIONAL ISSUES.

  Patient problems: Insufficient Information

  MAUDE report 21976927 ↗
• MalfunctionMay 7, 2025Break; Break

  IT WAS REPORTED THAT THE AIMING ARM FROM ONE OF THE RFNA SET BROKE WHEN SURGEON TRIED TO ROTATE THE NAIL INTRA-OPERATIVELY. CASE WAS COMPLETED WITH NO ADDITIONAL ISSUES.

  Patient problems: Insufficient Information

  MAUDE report 21976926 ↗
• MalfunctionMay 2, 2025Device Slipped; Device-Device Incompatibility; Device Slipped; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING THE CASE WHILE DRILLING THE NAIL MISSED WHEN PUTTING IT THROUGH THE AIMING ARM. THEY BELIEVE THE AIMING ARM IS LOOSE. THEY HAD TO USE A MALLOT AND SHORT DRILL BIT AND DO PERFECT CIRCLES. THERE WAS A SURGICAL DELAY OF 5 MINUTES. PROCEDURE COMPLETED SUCCESSFULLY. PATIENT OUTCOME WAS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 21951297 ↗
• MalfunctionFeb 21, 2025Break; Break

  IT WAS REPORTED THAT THE AIMING ARM RADIOLUCENT WAS BROKEN POST-OPERATIVELY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21437136 ↗
• MalfunctionFeb 12, 2025Break; Break

  AMING ARM FROM RFNA SET IS BROKEN. SEE PICTURE. DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING? NO, DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? NO, PATIENT STATUS/ OUTCOME / CONSEQUENCES: NO,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21364112 ↗
• MalfunctionDec 19, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON (B)(6) 2024, PRE-OPERATIVELY, WHEN OPENING SETS AND PREPARING THE BACK TABLE, SURGICAL TECH AND NOTICED THE AIMING ARM FOR THE RFNA WAS FAULTY AS WE COULDN'T CLICK INTO IT. ALSO, THE SMALL FRAG SET THAT SALES REP OPENED AND NOTICED THE PROTECTIVE LAYER WAS PEELING OFF AND WANTED TO REPORT THAT AS WELL. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20975621 ↗
• MalfunctionNov 19, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING AN RFNA PROCEDURE WHILE ENTRY REAMING, THE SLEEVE BENT FROM PRESSURE OF THE SLEEVE AND DULL NESS OF THE REAMER. WHILE INSERTING THE LAW, OBLIQUE SCREWS MISSED THE NAILS. NO OTHER INFORMATION WAS PROVIDED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20723355 ↗
• MalfunctionOct 25, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON OCTOBER 10, 2024, THE TIBIAL NAIL AIMING ARM, DRILL SLEEVE/DRILL WERE MISSING THE TARGETED HOLES- EVEN WHEN NOT IN OR USE; TESTED IN SPD AFTER REPEATED INCIDENCES OF CHALLENGES WITH TARGETING IN CASES. REPLACED CONNECTING SCREW, USED A NEW NAIL, AND TESTED THE SETUP AND THE DRILL HITS THE NAIL, MISSING THE TARGETED HOLES. TRIED SOME WITH A NEW LOAN SET AND THERE WERE NO ISSUES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20535839 ↗
• MalfunctionOct 25, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, THE TIBIAL NAIL AIMING ARM, DRILL SLEEVE/DRILL WERE MISSING THE TARGETED HOLES- EVEN WHEN NOT IN OR USE; TESTED IN SPD AFTER REPEATED INCIDENCES OF CHALLENGES WITH TARGETING IN CASES. REPLACED CONNECTING SCREW, USED A NEW NAIL, AND TESTED THE SETUP AND THE DRILL HITS THE NAIL, MISSING THE TARGETED HOLES. TRIED SOME WITH A NEW LOAN SET AND THERE WERE NO ISSUES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20535394 ↗
• MalfunctionOct 8, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024, THE ITEM WAS OBSERVED TO BE BROKEN INTRA-OPERATIVELY. THE DEVICE WAS UTILIZED WITH NO ADVERSE EFFECTS INTRA-OPERATIVELY NOR DELAYS IN THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20396112 ↗
• MalfunctionSep 20, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024, DURING SURGERY IT WAS NOTICED THAT THE AIMING ARM FOR THE TIBIAL NAIL ADVANCED WAS BROKEN IN ONE SPOT. IT DID NOT AFFECT THE SURGERY THOUGH. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20266500 ↗
• MalfunctionSep 12, 2024Break; Break

  IT WAS REPORTED THAT ON AUG 28, 2024 A PIECE FROM THE RFNA AIMING GUIDE BROKE OFF.

  Patient problems: Insufficient Information

  MAUDE report 20199660 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K201346. One submission often covers many models, so check the product and lot details in each record.

• 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
• 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