NA 03.043.029Recalls & reported problems

Summary

The FDA's MAUDE database contains 503 adverse event reports that list this exact device (DI 10886982297396), received between Aug 18, 2021 and Sep 25, 2026 — classified as 503 malfunctions.

The most frequently reported specific device problem is “Break” (286 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 25 most recent of 503 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Device-Device Incompatibility

  It was reported on an unknown date that they were writing to report an issue with the aiming arm they have in one of our four Tibia Nail Advanced sets. They have used the aiming arm on the three separate occasions with issues using both the hybrid insertion handle and the stainless steel insertion handle. On all three occasions that they are reporting, it has missed the proximal static hole when they go to drill, which is causing a great deal of frustration with our surgeons. They are unsure of what else could be causing this issue at this point as we have also replaced the steel insertion handle, and all other sets seem to be okay.

  Patient problems: Insufficient Information

  MAUDE report 50895770 ↗
• MalfunctionSep 25, 2026Device-Device Incompatibility

  It was reported on an unknown date that they were writing to report an issue with the aiming arm they have in one of our four Tibia Nail Advanced sets. They have used the aiming arm on the three separate occasions with issues using both the hybrid insertion handle and the stainless steel insertion handle. On all three occasions that they are reporting, it has missed the proximal static hole when they go to drill, which is causing a great deal of frustration with our surgeons. They are unsure of what else could be causing this issue at this point as we have also replaced the steel insertion handle, and all other sets seem to be okay.

  Patient problems: Insufficient Information

  MAUDE report 50895756 ↗
• MalfunctionSep 22, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50860000 ↗
• MalfunctionSep 22, 2026Device-Device Incompatibility

  It was reported on an unknown date that they were writing to report an issue with the aiming arm they have in one of our four Tibia Nail Advanced sets. They have used the aiming arm on the three separate occasions with issues using both the hybrid insertion handle and the stainless steel insertion handle. On all three occasions that they are reporting, it has missed the proximal static hole when they go to drill, which is causing a great deal of frustration with our surgeons. They are unsure of what else could be causing this issue at this point as we have also replaced the steel insertion handle, and all other sets seem to be okay.

  Patient problems: Insufficient Information

  MAUDE report 50853291 ↗
• MalfunctionSep 11, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50742898 ↗
• MalfunctionJun 9, 2026Device-Device Incompatibility

  IT WAS REPORTED ON AN UNKNOWN DATE, DURING THE PROCEDURE, THE DRILL BIT HIT THE TIBIAL NAIL TWICE WHEN DRILLING TWO DIFFERENT HOLES. AT THE END OF THE PROCEDURE THE CONNECTING SCREW WOULD NOT COME OFF. THERE WAS 20 MINUTES OF DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25445117 ↗
• MalfunctionJun 4, 2026Break

  IT WAS REPORTED THAT THEY OPENED SET FOR A TIBIA NAIL CASE (TNA) AND FOUND THAT BOTH HOOKS WERE BROKEN OFF. THIS HADN'T BEEN AN ISSUE IN THE PREVIOUS CASE, BUT WAS NOW BROKEN WHEN OPENED FOR THIS CASE, DAYS LATER. ANOTHER TNA SET WITH THE ARM WAS RETRIEVED. WHEN IT WAS OPENED ONE OF THE HOOKS WAS BROKEN OFF OF IT. THE SETS ARE NOT LOCKED WITH ANY INSTRUMENTATION TO CREATE EXCESSIVE PRESSURE. ALL BY HAND AND NOT EXCESSIVE BY HAND. THESE ARE FROM SEPARATE FACILITIES AND DIFFERENT SURGEONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25399131 ↗
• MalfunctionJun 4, 2026Break

  IT WAS REPORTED THAT THEY OPENED SET FOR A TIBIA NAIL CASE (TNA) AND FOUND THAT BOTH HOOKS WERE BROKEN OFF. THIS HADN'T BEEN AN ISSUE IN THE PREVIOUS CASE, BUT WAS NOW BROKEN WHEN OPENED FOR THIS CASE, DAYS LATER. ANOTHER TNA SET WITH THE ARM WAS RETRIEVED. WHEN IT WAS OPENED ONE OF THE HOOKS WAS BROKEN OFF OF IT. THE SETS ARE NOT LOCKED WITH ANY INSTRUMENTATION TO CREATE EXCESSIVE PRESSURE. ALL BY HAND AND NOT EXCESSIVE BY HAND. THESE ARE FROM SEPARATE FACILITIES AND DIFFERENT SURGEONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25398984 ↗
• MalfunctionMay 19, 2026Break

  IT WAS REPORTED THE CLIPS ON THE AIMING ARMS BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25218941 ↗
• MalfunctionMay 19, 2026Break

  IT WAS REPORTED THE CLIPS ON THE AIMING ARMS BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25218908 ↗
• MalfunctionMay 7, 2026Break

  IT WAS REPORTED THAT THE AIM-ARM RADIOLUC EXPERIENCED A SNAPPED-OFF KNOB, WITH THE DAMAGE IDENTIFIED DURING A LOAN KIT INSPECTION. THE EVENT WAS DISCOVERED BY A TECHNICIAN DURING INSPECTION, AND THERE WAS NO INVOLVEMENT OF A SURGICAL PROCEDURE OR PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25113773 ↗
• MalfunctionMay 7, 2026Device-Device Incompatibility

  WHEN DRILLING THE PROXIMAL MEDIAL TO LATERAL HOLES ON THE NAIL, THE CARBON FIBER AIMING ARM WAS MISALIGNED, LEADING TO A FAIL IN DRILLING USING THE INSTRUMENTATION. THIS CAUSED DELAY IN SURGERY TIME. NO COMPLICATIONS FOR PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25112117 ↗
• MalfunctionMay 1, 2026Break

  IT WAS REPORTED ON(B)(6) 2026, DURING A PROCEDURE TWO DEVICES BROKE. WHEN THEY WERE CLIPPING THE AIMING ARM ON, A PIECE OF THE CARBON FIBER BROKE OFF. ON INSERTION OF THE TIBIAL NAIL, THE METAL PIN ON THE IMPACTOR BROKE AND THE SPRING FELL OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25058419 ↗
• MalfunctionMay 1, 2026Break

  IT WAS REPORTED THAT ON (B)(6) 2026, THE SURGEON WAS HAMMERING IN A TIBIA NAIL WITH THE AIMING ARM ATTACHED TO THE INSERTION HANDLE WHICH MUST'VE WEAKENED ONE OF THE HOOKS THAT HOOKS ONTO ONE OF THE PEGS OF THE AIMING ARM BECAUSE WHEN HE WENT TO TAKE THE AIMING ARM OFF ONE OF THOSE HOOKS SNAPPED OFF. THE SURGEON NOTICED THAT THE HOOK BROKE OFF AND THINKS IT HAS MESSED WITH THE CONNECTION BETWEEN THE AIMING ARM AND THE INSERTION HANDLE. THERE WAS NO SURGICAL DELAY. SURGEON HAD TO MANIPULATE THE AIMING ARM IN ORDER FOR THE DRILL BITS GOING THROUGH THE TROCARS TO GO THROUGH THE NAIL AND NOT HIT THE NAIL. PROCEDURE WAS SUCCESSFULLY COMPLETED. THE AIMING ARM HOOK BROKE OFF AND WENT ONTO THE FLOOR OF THE OPERATING ROOM. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25056611 ↗
• MalfunctionApr 29, 2026Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, HANDLE OF AIMING ARM BROKE DURING HANDLING. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25027724 ↗
• 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 24973272 ↗
• 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 24939204 ↗
• MalfunctionApr 9, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2026 DURING A PROCEDURE, SURGEON USED A TIBIAL NAIL AND THE PROXIMAL INTERLOCK "MISSED" THE HOLE IN THE NAIL WHEN INSERTING. SURGEON REMOVED THE SCREW, REPOSITIONED AIMING ARM AND INSERTION HANDLE, REDRILLED, THEN REINSERTED THE SCREW THROUGH THE NAIL. THE SURGERY WAS DELAYED BY 10 MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24832915 ↗
• MalfunctionApr 1, 2026Break

  IT WAS REPORTED THAT THE TNA AIMING ARM BROKE DURING REMOVAL FROM THE INSERTIONS HANDLE AFTER SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24755753 ↗
• MalfunctionMar 30, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT INSERTION HANDLE/ RADIOLUCENT MEDIUM AND AIM-ARM RADIOLUC WERE INVOLVED IN AN EVENT DURING A PARAPATELLAR TIBIA NAIL INSERTION PROCEDURE. WHILE PLACING PROXIMAL INTERLOCKING SCREWS USING THE AIMING ARM, THE DRILL BIT STRUCK THE NAIL, RESULTING IN A SLIGHT PROCEDURAL DELAY OF 3-5 MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WAS NO REPORTED PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24726998 ↗
• MalfunctionMar 25, 2026Break

  IT WAS REPORTED ON (B)(6) 2026 THE SURGEON WAS INSERTING A TIBIA NAIL. THE NAIL WAS INSERTED AND THE JIG WAS THEN HOOKED ONTO THE NAIL INSERTOR. WHEN THE AIMING ARM WAS CLICKED ONTO THE JIG THE LATCH BROKE. NO PATIENT HARM WAS CREATED AND WE OPENED ANOTHER SET TO COMPLETE THE PROCEDURE. NO PATIENT HARM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24691899 ↗
• MalfunctionMar 24, 2026Break

  ADDITIONAL INFORMATION RECEIVED: A. DATE OF EVENT (IF AVAILABLE): WHAT IS THE TIMING OF THE REPORTED EVENT? (PRE-OP, INTRA-OP, POST-OP)? - NO ONE SPECIFIC EVENT. JUST DEGRADATION OF THE GRAPHIC CASE AND WORRIES WITH THE HOSPITAL THAT STERILIZATION MIGHT NOT BE GREAT WITH FLAKING OF TRAY. NO CERTAIN OCCURRENCE. NO PATIENT ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24681562 ↗
• MalfunctionMar 20, 2026Crack; Device-Device Incompatibility

  IT WAS REPORTED THAT AIM-ARM RADIOLUC AND UNK - NAIL INSERTION HANDLES WERE INVOLVED IN AN INTRA-OPERATIVE EVENT. DURING A TIBIAL NAIL PROCEDURE, THE PROXIMAL LOCKING SCREWS IN THE MEDIAL ASPECT OF THE AIMING ARM DID NOT ALIGN WITH THE HOLES IN THE TIBIAL NAIL. TROUBLESHOOTING STEPS, INCLUDING CHECKING THE AIMING ARM CONNECTION AND USING A MALLET TO ENSURE A TIGHT FIT, DID NOT RESOLVE THE MISALIGNMENT. ULTIMATELY, THE SURGICAL TEAM RESORTED TO FREEHAND DRILLING AND INSERTION OF THE LOCKING SCREWS. AFTER THE PROCEDURE, THE AIMING ARM AND INSERTION HANDLE WERE FOUND TO BE TIGHTLY CONNECTED AND REQUIRED PRYING APART, AND A SPLIT WAS OBSERVED IN ONE OF THE CLIPS ON THE AIMING ARM. THERE WAS NO REPORTED PATIENT HARM, BUT A SIGNIFICANT PROCEDURAL DELAY OF 30 MINUTES OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24647823 ↗
• MalfunctionMar 16, 2026Break

  IT WAS REPORTED THE PEGS THAT ATTACH TO THE INSERTION ARMS BROKE. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24607167 ↗
• MalfunctionMar 11, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A TIBIAL NAIL ADVANCE PROCEDURE, AFTER USING THE COMPRESSION FEATURE WITHIN THE NAIL HANDLE, AND AFTER THE DYNAMIC PROXIMAL SCREW WAS INSERTED, SURGEON ATTEMPTED TO HOLD THE COMPRESSION WITH THE 2ND PROXIMAL STATIC SCREW, BUT THE DRILL BIT HIT THE NAIL AND WAS NOT GOING THROUGH IN ANY MEANS. SURGEON TRIED MINIMAL MANIPULATION MOVING HIS HAND UP AND DOWN, AND EVENTUALLY THE DRILL WENT THROUGH BUT OUTSIDE THE NAIL. THE SURGEON HAD TO REMOVE THE GUIDE ARM AND DRILLED THE HOLE FREE-HAND UNDER X-RAY GUIDANCE. THE EVENT RESULTED IN A 20-MINUTE SURGICAL DELAY AND REQUIRED ADDITIONAL X-RAY IMAGING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED, AND THERE WERE NO REPORTED PATIENT CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24570645 ↗

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