NA 03.233.005Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10886982288356), received between Jun 21, 2021 and Aug 19, 2026 — classified as 23 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (18 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 19, 2026Device-Device Incompatibility

  It was reported that the Insertion handle 03.233.005 and Aiming arm 03.233.006 would not separate without extreme force. There was no patient harm or surgical delay.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50328970 ↗
• MalfunctionAug 10, 2026Break; Corroded

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50192160 ↗
• MalfunctionJul 1, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A CASE ON APRIL 8, 2026 THE TARGETED DISTAL LOCKERS ON THE RFNA AIMING ARM WERE NOT ALIGNING PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25680920 ↗
• MalfunctionMay 19, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE INSTRUMENT DOES NOT PROPERLY HOLD THE NAIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25216391 ↗
• 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 23958894 ↗
• MalfunctionDec 10, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT WHILE TRYING TO THREAD THE CONNECTING SCREW THROUGH THE INSERTION HANDLE IT WAS NOTICED THAT IT WAS UNABLE TO THREAD IN AND WAS GETTING STUCK. THUS THE NAIL COULD NOT BE CONNECTED TO THE INSERTION HANDLE. THE UPPER THREADS ON THE CONNECTING SCREW APPEAR TO BE DAMAGED. ANOTHER SET WAS USED AND THE CASE WAS FINISHED SUCCESSFULLY. THE ISSUE RESULTED IN A DELAY OF 3-4 MINUTES TO THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23769615 ↗
• 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 22437502 ↗
• MalfunctionDec 5, 2024Break; Break

  IT WAS REPORTED THAT ON NOVEMBER 22, 2024, THE ITEM FOUND BROKEN IN SPD. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20852904 ↗
• MalfunctionNov 19, 2024Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE WIRE BENT IN MULTI GUIDE FROM PRESSURE SO WIRE DOESN¿T SLIDE SMOOTHLY ANYMORE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20723187 ↗
• MalfunctionSep 11, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024 , TEETH OF DEVICE BROKE. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20189054 ↗
• MalfunctionAug 22, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON JUNE 16, 2024 , DURING A PROFESSIONAL EDUCATION EVENT (LOWER LIMB MASTERS COURSE) WITH HUMAN ANATOMIC SPECIMENS IN (B)(6), THERE WAS SOME DIFFICULTY WHEN ASSEMBLING THE RFNA CONNECTION BOLT INTO THE RFNA INSERTION HANDLE. THIS DIFFICULTY WAS ENCOUNTERED ON THREE OF THE 20 WORKSHOP TABLES. THE TECHNICIAN IN THE LAB WAS ABLE TO ASSEMBLE THE PARTS AFTER 10 MINUTES, WHICH REQUIRED SOME FORCE. THERE WAS NO PATIENT HARM. THIS REPORT INVOLVES ONE INSERTION HANDLE RADIOLUCENT. THIS IS REPORT 2 OF 10 FOR (B)(4). THIS REPORT IS RELATED TO (B)(4), WHICH CAPTURE ADDITIONAL IMPACTED PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20038255 ↗
• MalfunctionAug 22, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON JUNE 16, 2024, DURING A PROFESSIONAL EDUCATION EVENT (LOWER LIMB MASTERS COURSE) WITH HUMAN ANATOMIC SPECIMENS IN (B)(6), THERE WAS SOME DIFFICULTY WHEN ASSEMBLING THE RFNA CONNECTION BOLT INTO THE RFNA INSERTION HANDLE. THIS DIFFICULTY WAS ENCOUNTERED ON THREE OF THE 20 WORKSHOP TABLES. THE TECHNICIAN IN THE LAB WAS ABLE TO ASSEMBLE THE PARTS AFTER 10 MINUTES, WHICH REQUIRED SOME FORCE. THERE WAS NO PATIENT HARM. THIS REPORT INVOLVES ONE INSERTION HANDLE RADIOLUCENT. THIS IS REPORT 1 OF 10 FOR (B)(4). THIS REPORT IS RELATED TO B)(4), WHICH CAPTURE ADDITIONAL IMPACTED PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20037700 ↗
• MalfunctionAug 22, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON JUNE 16, 2024, DURING A PROFESSIONAL EDUCATION EVENT (LOWER LIMB MASTERS COURSE) WITH HUMAN ANATOMIC SPECIMENS IN BANGKOK, THERE WAS SOME DIFFICULTY WHEN ASSEMBLING THE RFNA CONNECTION BOLT INTO THE RFNA INSERTION HANDLE. THIS DIFFICULTY WAS ENCOUNTERED ON THREE OF THE 20 WORKSHOP TABLES. THE TECHNICIAN IN THE LAB WAS ABLE TO ASSEMBLE THE PARTS AFTER 10 MINUTES, WHICH REQUIRED SOME FORCE. THERE WAS NO PATIENT HARM. THIS REPORT INVOLVES ONE INSERTION HANDLE RADIOLUCENT. THIS IS REPORT 4 OF 10 FOR (B)(4). THIS REPORT IS RELATED TO (B)(4) AND (B)(4), WHICH CAPTURE ADDITIONAL IMPACTED PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20036053 ↗
• MalfunctionAug 22, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, WHILE ATTEMPTING TO DRILL THE DISTAL TRANSVERSE HOLE, THE DRILL BIT WOULD NOT PASS THROUGH THE HOLE AND HIT THE NAIL. THERE WAS A SURGICAL DELAY OF FOUR MINUTES. IT WAS REPORTED THAT THIS HAPPENED MULTIPLE TIMES ON THE SAME DAY WITH THE SAME INSTRUMENTS. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE INSERTION HANDLE RADIOLUCENT. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 20035882 ↗
• MalfunctionAug 22, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, DURING A PROFESSIONAL EDUCATION EVENT (LOWER LIMB MASTERS COURSE) WITH HUMAN ANATOMIC SPECIMENS IN BANGKOK, THERE WAS SOME DIFFICULTY WHEN ASSEMBLING THE RFNA CONNECTION BOLT INTO THE RFNA INSERTION HANDLE. THIS DIFFICULTY WAS ENCOUNTERED ON THREE OF THE 20 WORKSHOP TABLES. THE TECHNICIAN IN THE LAB WAS ABLE TO ASSEMBLE THE PARTS AFTER 10 MINUTES, WHICH REQUIRED SOME FORCE. THERE WAS NO PATIENT HARM. THIS REPORT INVOLVES ONE INSERTION HANDLE RADIOLUCENT. THIS IS REPORT 3 OF 10 FOR. THIS REPORT IS RELATED TO (B)(4) WHICH CAPTURE ADDITIONAL IMPACTED PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20035440 ↗
• MalfunctionJul 22, 2024Device-Device Incompatibility; Device-Device Incompatibility

  THIS IS REPORT 6 OF 10 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19793653 ↗
• MalfunctionOct 25, 2023Device-Device Incompatibility; Device-Device Incompatibility

  THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF 10-15 MINUTES.

  Patient problems: Insufficient Information

  MAUDE report 18004160 ↗
• MalfunctionJul 11, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6)2023, THE SURGEON REMARKED THAT THE RFNA AIMING ARM WAS MISSING THE CROSS POST THAT CONNECTS TO INSERTION HANDLE. NO CASE DELAYS. THE PATIENT AND CASE OUTCOME WERE GOOD. THIS REPORT IS FOR ONE (1) INSERTION HANDLE RADIOLUCENT. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17302072 ↗
• MalfunctionFeb 24, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DUE TO A COMPLETE RE-FRACTURE AFTER SURGERY, THE RFNA WAS EXPLANTED AND REVISED TO A 12 MM DIAMETER 320 MM LONG NAIL ON (B)(6) 2023. THIS REPORT IS RELATED TO (B)(4), WHICH REPORTS THE REVISION SURGERY THAT OCCURRED ON (B)(6) 2023. THIS IS REPORT 1 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16439751 ↗
• MalfunctionJan 26, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON UNKNOWN DATE, AN EVENT OCCURRED WHERE WE DID A NAIL PLATE COMBO, THE FIRST PLATE WAS USED THE CENTRAL FIXED ANGLE SCREW HOLE DID NOT LOCK INTO THE PLATE, WE ENDED UP TAKING OUT THE PLATE AND USING A SECOND ONE OF A LONGER LENGTH. WE ASSEMBLED THE NAIL AND THEN INSERTED THE LM / ML SCREW HOLES AND THE DRILL BIT MISSED THE NAIL, I¿M NOT ENTIRELY SURE IF IT WAS DUE TO THE NOTCH OF THE TKA REPLACEMENT OR BECAUSE OF THE SCREWS FROM THE PLATE DIVERGING THE DRILL BIT. THE 13MM SLEEVE WAS BENT DURING THE CASE AS WELL FROM PUSHING AND THE ENTRY REAMER WAS STUCK IN THE SLEEVE. (B)(4) IS RELATED TO (B)(4). (B)(4) CAPTURES POST-OP. (B)(4) CAPTURES INTRA-OP. THIS COMPLAIN INVOLVES FIVE (5) DEVICES. THIS REPORT IS FOR ONE (1) INSERTION HANDLE RADIOLUCENT. THIS IS REPORT 3 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16250646 ↗
• MalfunctionNov 21, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2022, THAT THEY HAD AN ISSUE WITH THE RETROGRADE FEMORAL NAIL ADVANCED SYSTEM AIMING ARM NOT TARGETING THE NAIL CORRECTLY. THE DRILL BIT MISSED THE DISTAL TRANSVERSE HOLE IN THE NAIL. NO ADDITIONAL INFORMATION WAS REPORTED. THIS REPORT IS FOR ONE (1) INSERTION HANDLE RADIOLUCENT THIS IS REPORT 1 OF 8 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15837641 ↗
• MalfunctionOct 5, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING AN UNKNOWN PROCEDURE, WHILE IMPLANTING THE NAIL THE SURGEON COMPRESSED THE NAIL INTO THE FRACTURE. WHILE DOING THIS, SHE LOCKED IN THE DISTAL INTERLOCKS AND MALLETED THE INSERTION HANDLE WHILE THE AIMING ARM WAS ON. THE CLIP ON THE AIMING ARM AND THE PIECE ON THE INSERTION HANDLE BROKE OFF. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS A SURGICAL DELAY OF TEN (10) MINUTES. IT IS UNKNOWN IF THERE WERE FRAGMENTS GENERATED. PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) INSERTION HANDLE RADIOLUCENT. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12578220 ↗
• MalfunctionJun 21, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, AN EVENT OCCURRED THAT INVOLVES THE AIMING ARM RADIOLUCENT AND INSERTION HANDLE RADIOLUCENT WITH UNKNOWN ALLEGATION. THERE IS NO SURGICAL DELAY REPORTED. IT IS UNKNOWN IF THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) INSERTION HANDLE RADIOLUCENT THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12036826 ↗

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-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