NA 03.037.013Recalls & reported problems

Summary

The FDA's MAUDE database contains 117 adverse event reports that list this exact device (DI 10886982070296), received between Jan 11, 2017 and May 8, 2026 — classified as 8 injuries, 109 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (83 reports).

9 other recalls cover devices cleared under the same FDA submission (K131548); 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 117 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 8, 2026Device-Device Incompatibility

  IT WAS REPORTED ON (B)(6) 2026 THAT TFNA JIG IS HINDERING DRILLS FROM GOING THROUGH THE ROD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25125859 ↗
• MalfunctionMay 8, 2026Device-Device Incompatibility

  IT WAS REPORTED ON (B)(6) 2026 THAT TFNA JIG IS HINDERING DRILLS FROM GOING THROUGH THE ROD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25125730 ↗
• MalfunctionApr 1, 2026Device-Device Incompatibility

  IT WAS REPORTED ON AN UNKNOWN DATE DURING A TFNA PROCEDURE, THE HELICAL BLADE MISSED THE NAIL. NOT ENTIRELY SURE WHAT HAPPENED BUT DOCTOR ASKED TO REPLACE BOTH HYBRID TFNA HANDLES, X4 CONNECTING SCREWS, AIMING ARMS X 2, AND WRENCHES X 2. IN ANOTHER TFNA CASE, HIT NAIL WITH SUPRAPATELLAR HANDLE; 4 WEBER CLAMPS BROKE, AND 4 POINT TO POINT. THE LOBSTERS DID NOT CLICK ALL THE WAY. SURGERY WAS NOT DELAYED DUE TO THE REPORTED EVENT. NO PATIENT CONSEQUENCES. (B)(4) AND (B)(4) ARE RELATED TO EACH OTHER. (B)(4) HAS BEEN CREATED TO CAPTURE THE ANOTHER EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24756362 ↗
• MalfunctionApr 1, 2026Device-Device Incompatibility

  IT WAS REPORTED ON AN UNKNOWN DATE DURING A TFNA PROCEDURE, THE HELICAL BLADE MISSED THE NAIL. NOT ENTIRELY SURE WHAT HAPPENED BUT DOCTOR ASKED TO REPLACE BOTH HYBRID TFNA HANDLES, X4 CONNECTING SCREWS, AIMING ARMS X 2, AND WRENCHES X 2. IN ANOTHER TFNA CASE, HIT NAIL WITH SUPRAPATELLAR HANDLE; 4 WEBER CLAMPS BROKE, AND 4 POINT TO POINT. THE LOBSTERS DID NOT CLICK ALL THE WAY. SURGERY WAS NOT DELAYED DUE TO THE REPORTED EVENT. NO PATIENT CONSEQUENCES. (B)(4) ARE RELATED TO EACH OTHER. (B)(4) HAS BEEN CREATED TO CAPTURE THE ANOTHER EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24756259 ↗
• MalfunctionFeb 5, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE GUIDE WIRE MISSED THE NAIL HOLE FOR HELICAL BLADE. SURGERY WAS DELAYED FOR FORTY (40) MINUTES DUE TO THE REPORTED EVENT. THE NAIL WAS REMOVED AND REINSERTED USING SECOND SET. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24273309 ↗
• MalfunctionJan 23, 2026Device-Device Incompatibility

  IT WAS REPORTED DURING A TFNA, THE HELICAL BLADE OR TRIPLE TROCAR HAS BEEN CATCHING. WE WEREN¿T ABLE TO GET THE HELICAL BLADE INSERTED/TROCAR OUT OF THE AIMING ARM/COMPRESSION NUT. NOT SURE WHICH PART WAS THE ISSUE. NO PATIENT HARM. SURGICAL DELAY OF 5-10 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24161333 ↗
• MalfunctionDec 5, 2025Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL INFORMATION RECEIVED STATES THAT THIS WAS AN INTRAOPERATIVE EVENT. THESE HAVE BEEN IN THE HOSPITAL IN ROTATION SINCE THE TFNA CAME OUT. THE PAST THREE TIMES WE HAVE USED THEM, THE TRIPLE SLEEVE GETS STUCK INSIDE OF THE AIMING ARM. HAVE TO USE A MALLET AGAINST THE BUTTRESS WHEEL TO GET IT OUT. THESE THINGS HAVE TAKEN A BEATING OVER THE YEARS AND NEED TO BE REPLACED. MY SURGEON HAS THREATENED TO USE ANOTHER COMPANY IF WE DO NOT REPLACE THEM. 130° AIMING ARM IS NO LONGER NEEDED. I ONLY NEED THE OUTER SLEEVE OF THE TRIPLE SLEEVE AND THE HELICAL BLADE INSERTION HANDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23727895 ↗
• MalfunctionDec 1, 2025Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  IT WAS REPORTED ON (B)(6) 2025, THAT USER WAS DOING IN SERVICE WITH TFNA. THE BLADE/SCREW SLEEVE WAS GETTING STUCK IN THE 130 DEGREE AIMING ARM. IT WAS VERY HARD TO REMOVE. THERE WERE NO PATIENT STATUS/ OUTCOME / CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23681873 ↗
• MalfunctionNov 24, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON (B)(6) 2025 THAT STAFF INFORMED WHILE USING THE TFNA INSTRUMENTATION FOR A HIP FRACTURE, THE PIN MISSED THE NAIL THROUGH THE AIMING JIG. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23639018 ↗
• MalfunctionSep 26, 2025Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2025, THE TFNA AIMING ARM BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23155132 ↗
• MalfunctionSep 19, 2025Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2025, PRODUCT WAS FOUND BROKEN IN DECONTAMINATION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23100936 ↗
• MalfunctionSep 12, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED DURING DOING A STAFF IN SERVICE FOR TFNA. THE BLADE\SCREW GUIDE WOULD NOT SLIDE INTO THE AIMING ARM. NOT SURE IF SOMETHING IS BENT ON AIMING ARM OR BLADE\SCREW GUIDE. NO PATIENT STATUS/ OUTCOME / CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23043065 ↗
• MalfunctionSep 3, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE DISTAL TARGETING DID NOT WORK PROPERLY FOR INSERTING THE LOCKING SCREW ON A CASE. WHEN DRILLING FOR THE DISTAL SCREW, THE DRILL BIT WOULD COLLIDE WITH THE NAIL RATHER THAN PASS THROUGH FREELY. IT WAS ENSURED THAT ALL CONNECTION POINTS WERE TIGHT, INCLUDING THE CONNECTING SCREW FOR THE NAIL THAT ATTACHES THE INSERTION HANDLE AS WELL AS THE SCREW THAT FASTENS THE AIMING ARM TO THE INSERTION HANDLE AND THE PROBLEM PERSISTED. SURGERY WAS COMPLETED WITHOUT CONSIDERABLE DIFFICULTY. SURGEON PLACED DISTAL, LOCKING SCREW FREE HAND WITHOUT THE USE OF THE AIMING ARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22954614 ↗
• MalfunctionAug 28, 2025Crack; Detachment of Device or Device Component; Crack; Detachment of Device or Device Component

  IT WAS REPORTED ON (B)(6) 2025, THE CONNECTING SCREW ON TFNA AIMING JIG CRACKED AND FELL APART WHEN PLACING COMPRESSION ON THE TFNA BLADE. SURGICAL DELAY WAS UNKNOWN. IT IS UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22910991 ↗
• MalfunctionAug 4, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, AN ISSUE OCCURRED IN PRE-OP DURING SETUP FOR A TFNA. THE INSERTION ARM AND AIMING ARM FOR THE 300 DEGREE NAIL WERE NOT PROPERLY ALIGNED, WHICH WOULD HAVE RESULTED IN MISPLACEMENT OF LAG SCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22703289 ↗
• MalfunctionJul 31, 2025Break; Break

  IT WAS REPORTED THAT WHEN SETTING UP THE 130 DEGREE AIMING ARM FOR TFNA, THE ATTACHMENT KNOB BROKE IN HALF. NO PATIENT IN ROOM WHEN ITEM WAS BROKEN. HAD A BACKUP SET SO DID NOT CREATE A DELAY IN SURGERY. SECOND SET WAS OPENED FOR NEW AIMING ARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22678018 ↗
• MalfunctionJul 30, 2025Break; Break

  IT WAS REPORTED THAT REP HAS 4 SCREWDRIVERS THAT ARE NOT RETAINING TO THE SCREWDRIVER SHAFTS. THE SCREWS ARE FALLING OFF THE SCREWDRIVER SHAFT AND THEY'RE NOT HOLDING WELL AT ALL. ADDITIONALLY, AIMING ARMS AND 2 INSERTION HANDLES ARE BROKEN. ALL MALFUNCTIONS OCCURRED POST-OP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22663701 ↗
• MalfunctionJul 30, 2025Break; Break

  IT WAS REPORTED THAT REP HAS 4 SCREWDRIVERS THAT ARE NOT RETAINING TO THE SCREWDRIVER SHAFTS. THE SCREWS ARE FALLING OFF THE SCREWDRIVER SHAFT AND THEY'RE NOT HOLDING WELL AT ALL. ADDITIONALLY, AIMING ARMS AND 2 INSERTION HANDLES ARE BROKEN. ALL MALFUNCTIONS OCCURRED POST-OP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22663123 ↗
• MalfunctionJul 23, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE DRILL BIT GOT JAMMED IN THE INSERTION GUIDE AND TIP BROKE OFF DURING DRILLING PHASE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22581810 ↗
• MalfunctionJun 24, 2025Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  TFNA AIMING ARM AND ALL ASSOCIATED PIECES NEED TO BE REPLACED DUE TO DIFFICULTY AND ABNORMALLY HIGH RESISTANCE EXPERIENCED WHEN INSERTING GUIDE SLEEVES. THEY APPEARED TO GET JAMMED AND STUCK BEFORE FULL INSERTION WAS ACHIEVED. THIS WAS DISCOVERED DURING REPROCESSING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22320706 ↗
• MalfunctionJun 18, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025 THE NAIL PORTION CAME OUT OF AIMING ARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22287599 ↗
• MalfunctionMay 13, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6), 2024 THE TARGETING DISTAL LOCKING SCREW MISSED THE LOCKING HOLE IN THE NAIL DURING A SHORT NAIL TFNA CASE. THERE WAS NO HARM TO THE PATIENT. THE SURGEON DISCONNECTED THE NAIL FROM THE HANDLE AND COMPLETED THE CASE WITH A DIFFERENT HANDLE THAT WAS ALREADY IN THE ROOM. THERE WAS A 2 MINUTES OF SURGICAL DELAY. THE TFNA CONSTRUCT WAS SUCCESSFULLY IMPLANTED. THERE WAS NO OTHER INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22009809 ↗
• InjuryMay 7, 2025Break; Break

  IT WAS REPORTED THAT DURING THE SURGERY THE ATTACHMENT SCREW BROKE OFF. THE SURGERY WAS DELAYED BY AROUND 5 MINUTES WHILE A SECOND SET WAS LOCATED. SURGERY COMPLETED SUCCESSFULLY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21978684 ↗
• MalfunctionMay 1, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT A TARGETING GUIDE WAS MISSING AND HITTING THE NAIL. SURGEONS WANT TO REPLACE ALL 130 DEGREE AIMING ATTACHMENTS. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 21942338 ↗
• MalfunctionMay 1, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT A TARGETING GUIDE WAS MISSING AND HITTING THE NAIL. SURGEONS WANT TO REPLACE ALL 130 DEGREE AIMING ATTACHMENTS. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 21942168 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K131548. One submission often covers many models, so check the product and lot details in each record.

• Z-1239-2024 · Jan 24, 2024 · Open, Classified
  TFNA Femoral Nail 9mm, right, 130, L 235mm-Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.944S
• Z-1240-2024 · Jan 24, 2024 · Open, Classified
  TFNA Femoral Nail 11mm, right, 130, L 235mm-Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.144S
• Z-1248-2023 · Feb 1, 2023 · Open, Classified
  TFN-Advanced Femoral Nail 12MM/130 DEG TI CANN TFNA 170MM STERILE. Intended for temporary fixation and stabilization of proximal femur fractures Part Number: 04.037.242S
• Z-1247-2023 · Feb 1, 2023 · Open, Classified
  TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 170MM - STERILE. Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.212S
• Z-1246-2023 · Feb 1, 2023 · Open, Classified
  TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 200MM STERILE. Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.213S
• Z-0126-2016 · Sep 21, 2015 · Terminated
  Synthes Screw Inserter; for use with Intramedullary Rod, orthopedic device. Used to secure the head element to the head element inserter to prevent disengagement during head eleme
• Z-2091-2015 · Jun 10, 2015 · Terminated
  Helical Blade Inserter for Trochanteric Fixation Nail-ADVANCED (TFNA); intended to secure the head element to the head element inserter to prevent disengagement during head element
• Z-1600-2015 · Apr 9, 2015 · Terminated
  TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
• Z-1352-2015 · Feb 24, 2015 · Terminated
  Synthes 130 Degree Aiming Arm and 125 Degree Aiming Arm; The 130 Degree Aiming Arm and 125 Degree Aiming Arm are a part of the TFN-ADVANCED (TFNA) System. The TFN-ADVANCED Proxima