NA 03.233.003Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10886982288233), received between Nov 21, 2022 and Jan 5, 2026 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (10 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 16, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• 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 23958900 ↗
• MalfunctionDec 10, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  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 23769618 ↗
• MalfunctionDec 1, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT CONNECTING SCREW WOULD NOT CONNECT TO NAIL. THE CONNECTING SCREW THREADS WERE FLATTENED, WHICH IS WHY IT WOULD NOT CONNECT TO THE NAIL PROPERLY. NO ISSUE WITH THE NAIL ITSELF. NEW TRAY WAS OPENED. NO SURGICAL DELAY WAS REPORTED. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23682749 ↗
• MalfunctionApr 3, 2025Break; Break

  IT WAS REPORTED THAT THE TIP OF THE CONNECTION WAS BROKEN OFF IN THE HANDLE AND COULD NOT BE RETRIEVED. NO FRAGMENTS WERE RETAINED IN THE PATIENT. ADDITIONAL TRAYS WERE OPENED WHICH CAUSED A FIVE (5) TO TEN (10) MINUTE DELAY. THE PATIENT WAS REPORTED AS GOOD.

  Patient problems: Insufficient Information

  MAUDE report 21761476 ↗
• MalfunctionJul 22, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A LAB ON AN UNKNOWN DATE, THE PRODUCTS WOULD NOT MATE TOGETHER PROPERLY. THE CONNECTING SCREW WOULD NOT PASS THROUGH THE INSERTION HANDLE. IT APPEARED THAT THE CONNECTING SCREW WAS ALMOST OFF CENTER. THIS REPORT IS FOR A CONNECTING SCREW. THIS SIR REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19800129 ↗
• MalfunctionJul 22, 2024Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  THIS IS REPORT 3 OF 10 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19794026 ↗
• MalfunctionFeb 2, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS:IT WAS REPORTED THAT DURING SURGERY ON (B)(6) 2024, THE MATERIAL HAD EVIDENCE OF ORGANIC MATTER PRESENT. THE OPERATION COULD NOT BE PERFORMED AND HAD TO BE CANCELLED. THIS REPORT INVOLVES ONE CONNECTING SCREW. THIS IS REPORT 1 OF 1 FOR PC-001527528

  Patient problems: Insufficient Information

  MAUDE report 18629141 ↗
• MalfunctionDec 11, 2023Break; Crack; Device-Device Incompatibility; Break; Crack; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE CONNECTING SCREW IN QUESTION WAS UNABLE TO STERILIZE/ASSEMBLE. THE SCREW WAS CHIPPING AND CRACKING, MAKING IT UNABLE TO BE USED. THERE WAS NO REPORTED PATIENT OR PROCEDURE INTERACTION. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A CONNECTING SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18301073 ↗
• 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 18004132 ↗
• 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) CONNECTING SCREW. THIS IS REPORT 2 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16250597 ↗
• MalfunctionNov 22, 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)CONNECTING SCREW. THIS IS REPORT 7 OF 8 FOR COMPLAINT: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15842418 ↗
• 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) PROTECTION SLEEVE/ 11/8. THIS IS REPORT 4 OF 8 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15838243 ↗

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 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