NA 03.043.018Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 10886982297174), received between Aug 15, 2022 and Apr 27, 2026 — classified as 33 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (24 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. 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 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 27, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT AIMING ARM/ RADIOLUCENT AND INSERT-HANDLE RADIOLUC SHORT WERE INVOLVED IN A REPORTED EVENT. DURING A SURGICAL PROCEDURE, THE SURGEON EXPERIENCED MISTARGETING WHILE DRILLING PROXIMAL LOCKING HOLES USING THE TNA AIMING ARM AND THE NEWLY DESIGNED SUPRAPATELLAR INSERTION HANDLE. THE DRILL BIT DID NOT PASS EASILY THROUGH THE HOLES DURING PRE-CHECKS, BUT THE PROCEDURE CONTINUED. WHILE DRILLING THE PROXIMAL DYNAMIC HOLE, THE DRILL BIT NOTCHED THE NAIL, REQUIRING ADJUSTMENT OF THE JIG TO ALLOW PASSAGE. THE SURGEON NOTED THAT SUCH ADJUSTMENT SHOULD NOT BE NECESSARY. THE SURGERY WAS COMPLETED WITHOUT ANY HARM OR CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24999207 ↗
• MalfunctionApr 23, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT SURGEON EXPERIENCED MISTARGETING WHILST PERFORMING DRILLING OF PROXIMAL LOCKING HOLES THROUGH SUPRAPATELLAR AIMING ARM. KIT INCLUDED THE NEWLY DESIGNED SUPRAPATELLAR INSERTION HANDLE. SURGEON INDICATED THAT HE NEEDED TO MOVE THE AIMING ARM TO ALLOW THE DRILL BIT TO PASS THROUGH THE NAIL. THIS OCCURRED IN BOTH PROXIMAL STATIC HOLES. SURGEON EXPLAINED THAT HE FELT THE ISSUE WAS IN THE CONNECTION BETWEEN THE AIMING ARM AND INSERTION HANDLE. SURGEON WAS ABLE TO COMPLETE THE PROCEDURE AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24973290 ↗
• MalfunctionApr 21, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT AIMING ARM / RADIOLUCENT AND INSERT-HANDLE RADIOLUC SHORT WERE INVOLVED IN A REPORTED EVENT. THE SURGEON EXPERIENCED MISTARGETING DURING DRILLING OF PROXIMAL LOCKING HOLES THROUGH THE TNA AIMING ARM, NOTING THAT THE DRILL BIT WAS NOTCHING THE PROXIMAL HOLE AND REQUIRED REPOSITIONING OF THE AIMING ARM TO PASS THE DRILL BIT THROUGH THE NAIL. THE SURGEON SUSPECTED AN ALIGNMENT ISSUE BETWEEN THE AIMING ARM AND THE INSERTION HANDLE. THE SURGERY WAS COMPLETED WITHOUT ANY REPORTED PATIENT HARM OR CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24939180 ↗
• MalfunctionJan 20, 2026Device-Device Incompatibility

  INSTRUMENTS CAN NO LONGER BE SEPARATED FROM EACH OTHER. REGONGNZED AT THE DEPARTMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24122604 ↗
• MalfunctionDec 22, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THE AIMING ARM CAN HARDLY BE DETACHED FROM THE HANDLE. SURGERY WAS COMPLETED SUCCESSFULLY WITH AN UNKNOWN SURGICAL DELAY. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23864198 ↗
• MalfunctionNov 6, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT PRE-OPERATIVELY THE AIMING DEVICE COULD NOT BE CONNECTED WITH THE CONNECTION SCREW. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23486583 ↗
• MalfunctionOct 30, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A PROCEDURE ON AN UNKNOWN DATE, SEVERAL TIBIAL NAIL PRODUCTS HAD BEEN EXPERIENCING ONGOING ISSUES, SPECIFICALLY, THE INFRA, PARA, AND SUPRAPATELLAR HANDLES, AS WELL AS ALL ASSOCIATED JIGS AND CONNECTING SCREWS. THE JIG AND INSERTION DID NOT MATCH UP WITH THE NAIL. THE SOFT TISSUE SLEEVE WAS DEFORMED. LOT NUMBERS ON CONNECTING SCREWS ARE WORN OFF AND NOT LEGIBLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23425551 ↗
• MalfunctionOct 30, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A PROCEDURE ON AN UNKNOWN DATE, SEVERAL TIBIAL NAIL PRODUCTS HAD BEEN EXPERIENCING ONGOING ISSUES, SPECIFICALLY, THE INFRA, PARA, AND SUPRAPATELLAR HANDLES, AS WELL AS ALL ASSOCIATED JIGS AND CONNECTING SCREWS. THE JIG AND INSERTION DID NOT MATCH UP WITH THE NAIL. THE SOFT TISSUE SLEEVE WAS DEFORMED. LOT NUMBERS ON CONNECTING SCREWS ARE WORN OFF AND NOT LEGIBLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23425545 ↗
• MalfunctionOct 30, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A PROCEDURE ON AN UNKNOWN DATE, SEVERAL TIBIAL NAIL PRODUCTS HAD BEEN EXPERIENCING ONGOING ISSUES, SPECIFICALLY, THE INFRA, PARA, AND SUPRAPATELLAR HANDLES, AS WELL AS ALL ASSOCIATED JIGS AND CONNECTING SCREWS. THE JIG AND INSERTION DID NOT MATCH UP WITH THE NAIL. THE SOFT TISSUE SLEEVE WAS DEFORMED. LOT NUMBERS ON CONNECTING SCREWS ARE WORN OFF AND NOT LEGIBLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23425541 ↗
• MalfunctionSep 25, 2025Device-Device Incompatibility; Material Integrity Problem; Device-Device Incompatibility; Material Integrity Problem

  IT WAS REPORTED THAT WHEN INSPECTING THE TIBIAL NAIL ADVANCED PRIOR TO A CASE, THE TECH NOTICED THE DRIVING CAP WOULD NOT FIT INTO THE INSERTION HANDLE. HOWEVER IT WOULD FIT INTO THE SUPRAPATELLAR HANDLE. BECAUSE THE DRIVING CAP WAS FINE, IT WAS DETERMINED THE STANDARD INSERTION HANDLE WAS DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23141710 ↗
• MalfunctionAug 5, 2025Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2025 THE TNA INSERTION HANDLE (03.043.018) APPEARS TO HAVE THE PART OF THE HANDLE THAT CLICKS INTO THE NAIL, SHEARED OFF. THE NAILS SEEM TO NOT LOCK ON TO THE INSERTION HANDLE TIGHTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22714119 ↗
• MalfunctionMay 12, 2025Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE JIG WAS BROKEN DURING SURGERY. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO PATIENT CONSEQUENCE AND NO DELAY.

  Patient problems: Insufficient Information

  MAUDE report 22004716 ↗
• MalfunctionApr 24, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, THE IMPACT ATTACHMENT WAS PLACED INTRAOPERATIVELY, AND THE NAIL WAS DRIVEN IN; SUBSEQUENTLY, THE IMPACT ATTACHMENT COULD NO LONGER BE DETACHED FROM THE TARGETING DEVICE. DURING THE INSPECTION, IT WAS IDENTIFIED THAT IT CONTINUES TO GET STUCK. THERE WAS NO ALLEGATION AGAINST NAIL. THERE WAS A SURGICAL DELAY. NO OTHER MEDICAL INTERVENTION WAS REQUIRED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: Insufficient Information

  MAUDE report 21902758 ↗
• MalfunctionApr 21, 2025Break; Break

  THIS WAS REPORTED THAT AN INSTRUMENT BROKE DURING SURGERY. THE PATIENT STATUS WAS REPORTED TO BE FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21873685 ↗
• MalfunctionApr 21, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN AN UNKNOWN DATE IN 2025 WHILE DOING A TIBIAL NAIL, THE LENGTH OF THE NAIL WAS TOO LONG SO SURGEON HAD TO EXTRACT THE OLD NAIL. WHILE EXTRACTING THE PREVIOUS NAIL, THE DRIVE CAP PIN FELL OUT WHILE BACKSLAPPING. THE DRIVE CAP WAS UNABLE TO BE REMOVED FROM THE INFRAPATELLAR HANDLE AND IT WAS COLD WELDED. WHILE PLATING THE FIBULA THE DISTAL FIBULAR PLATE WAS USED AND SURGEON WAS UNABLE TO LOCK A SCREW IN THE SHAFT SO IT WAS NOT USED. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21873220 ↗
• MalfunctionMar 13, 2025Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THERE WAS A BROKEN INFRAPATELLAR INSERTION HANDLE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21592821 ↗
• MalfunctionFeb 26, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE SURGEON WAS USING THE TNA SYSTEM (INFRAPATELLAR INSTRUMENTATION) IN A SEMI-EXTENDED SURGICAL APPROACH AND THE AIMING ARM WAS MIS-TARGETED.

  Patient problems: Insufficient Information

  MAUDE report 21470402 ↗
• MalfunctionFeb 11, 2025Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE REPORTED PRODUCT WAS MISSING PEGS DURING PRE-OP SETUP. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21353975 ↗
• MalfunctionJan 30, 2025Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2025, DURING A TIBIAL NAILING CASE, THE INSTRUMENTS BROKE WHEN REMOVING THE NAIL FROM THE PATIENT AND WERE UNABLE TO BE USED. STAFF OPENED UP A SECOND TIBIAL NAIL TRAY AND WERE ABLE TO COMPLETE THE CASE IN A TIMELY MANNER WITH NO CONSEQUENCES. THERE WAS A SURGICAL DELAY OF 3 MINUTES. THERE WAS NO PATIENT STATUS/ OUTCOME / CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21272861 ↗
• MalfunctionJan 27, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING A TIBIAL NAIL CASE, THE SURGEON WAS UTILIZING THE NEW TNA CONNECTING SCREW, AND THE AIMING ARM CONSTRUCT DID NOT TARGET. IT WAS A 10MM DIAMETER NAIL THAT WAS INSERTED ABOUT 1CM. THE SURGEON NEEDED TO PERFORM PERFECT CIRCLES TO COMPLETE THE CASE.

  Patient problems: Insufficient Information

  MAUDE report 21245161 ↗
• MalfunctionNov 14, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE SALES REP WAS COVERING A TIBIAL NAIL, USING THE INFRAPATELLAR APPROACH. DURING THE CASE, THE AIMING ARM DID NOT APPROPRIATELY TARGET THE STATIC HOLE. THE SURGEON WAS INSTRUCTED TO MANIPULATE THE HANDLE A BIT, AND TIGHTEN THE CONNECTING SCREW, AFTER WHICH TIME THE DRILL BIT WAS ABLE TO GO THROUGH THE HOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20684000 ↗
• MalfunctionOct 2, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT STRIKING CAP PEN WAS COMING LOOSE WHEN THE HANDLE WAS ROTATED ON NAIL. THE THREADED TIP BROKE DURING SAME CASE. THERE WAS NO SURGICAL DELAY DUE TO THE REPORTED EVENT. NO FRAGMENTS WERE GENERATED. PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT OUTCOME/CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20352843 ↗
• MalfunctionJul 15, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, THE DRIVING CAP WOULD NOT DISENGAGE FROM THE INSERTION HANDLE. THIS OCCURRED AFTER THE CASE. THERE WAS NO PATIENT CONSEQUENCES OR MEDICAL INTERVENTION. SURGERY HAD BEEN COMPLETED WITH NO ADVERSE CONSEQUENCES. THIS REPORT IS FOR AN INSERTION HANDLE/ RADIOLUCENT SHORT. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19739961 ↗
• MalfunctionMay 9, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, THAT THE DRIVING CAPS GOT STUCK TO INSERTION HANDLE. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) INSERTION HANDLE/ RADIOLUCENT SHORT THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19282570 ↗
• MalfunctionMay 9, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, THAT THE DRIVING CAPS GOT STUCK TO INSERTION HANDLE. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) INSERTION HANDLE/ RADIOLUCENT SHORT THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19282569 ↗

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-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
• 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