NA 03.037.026Recalls & reported problems

Summary

The FDA's MAUDE database contains 225 adverse event reports that list this exact device (DI 10886982070425), received between Jan 11, 2017 and Sep 21, 2026 — classified as 7 injuries, 218 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (168 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 225 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Use of Device Problem

  It was reported while preparing the trays for sterile processing, it was noted several instruments were missing; they were discarded or lost. There was no patient or procedure involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50841507 ↗
• MalfunctionSep 21, 2026Use of Device Problem

  It was reported while preparing the trays for sterile processing, it was noted several instruments were missing; they were discarded or lost. There was no patient or procedure involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50841493 ↗
• MalfunctionSep 14, 2026Break; Corroded; Material Twisted/Bent

  It was reported several instruments were found broken, stripped, and rusted. No patient harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50755166 ↗
• MalfunctionSep 14, 2026Device-Device Incompatibility; Material Integrity Problem

  It was reported that the instrument threads are damaged and do not engage with the T handle for inserting the TFNA lag screw.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50752576 ↗
• MalfunctionSep 3, 2026Device-Device Incompatibility; Mechanical Jam

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50594487 ↗
• MalfunctionSep 1, 2026Device-Device Incompatibility; Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50548040 ↗
• MalfunctionMay 7, 2026Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT TWO (2) INSTRUMENTS WILL NOT THREAD TOGETHER MAKING IT UNUSABLE. THE SMALL SECTION OF THREADS ON THE CONNECTING SCREW HAVE BEEN DAMAGED IN SOME WAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25117030 ↗
• MalfunctionMay 7, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A POLY TRAUMA CASE, THE SURGEON RAN INTO SEVERAL ISSUES WITH BROKEN PRODUCT WHICH OCCURRED OR WAS NOTICED DURING THE PROCEDURE. ON INSERTION OF A TFNA NAIL INTO A SEVERELY COMMINUTED PROXIMAL THIRD FEMORAL SHAFT FRACTURE, THE IMPACTOR BROKE AND FELL ONTO THE FLOOR. THERE IS NO LOT NUMBER ASSOCIATED WITH THIS PRODUCT AS ALL NUMBERS HAVE BEEN FADED FROM THE IMPACTOR AFTER REPETITIVE USE. DURING THE SAME PROCEDURE, AFTER INSERTION OF THE TFNA LAG SCREW, THE LAG SCREW INSERTER AND THE LAG SCREW COUPLING DEVICE HAVE BECOME FUSED TOGETHER AND WILL NOT SEPARATE. IT WAS POSSIBLE TO DISLODGE THE DEVICE FROM THE TFNA SCREW, BUT THERE IS NO WAY TO NOW REMOVE THE COUPLING DEVICE FROM THE INSERTER. ON THE SAME PATIENT, A TIBIAL NAIL WAS ALSO COMPLETED. WHEN ATTEMPTING TO LOAD THE TNA ONTO THE INSERTION HANDLE, THEY WERE UNABLE TO ATTACH THE NAIL DUE TO THE TABS ON THE ATTACHMENT SITE BEING BENT. IT WOULD NOT ALLOW THE NAIL TO INSERT ONTO THE DEVICE APPROPRIATELY OR FOR THE CONNECTING BOLT TO INSERT TO REQUIRED DEPTH TO ATTACH TO THE TNA NAIL. TO SOLVE THIS ISSUE, THEY OPENED A SECOND TNA SET AND WERE ABLE TO SECURE A NAIL TO THIS DEVICE FOR INSERTION AND COMPLETE THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25116992 ↗
• MalfunctionMay 7, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A POLY TRAUMA CASE, THE SURGEON RAN INTO SEVERAL ISSUES WITH BROKEN PRODUCT WHICH OCCURRED OR WAS NOTICED DURING THE PROCEDURE. ON INSERTION OF A TFNA NAIL INTO A SEVERELY COMMINUTED PROXIMAL THIRD FEMORAL SHAFT FRACTURE, THE IMPACTOR BROKE AND FELL ONTO THE FLOOR. THERE IS NO LOT NUMBER ASSOCIATED WITH THIS PRODUCT AS ALL NUMBERS HAVE BEEN FADED FROM THE IMPACTOR AFTER REPETITIVE USE. DURING THE SAME PROCEDURE, AFTER INSERTION OF THE TFNA LAG SCREW, THE LAG SCREW INSERTER AND THE LAG SCREW COUPLING DEVICE HAVE BECOME FUSED TOGETHER AND WILL NOT SEPARATE. IT WAS POSSIBLE TO DISLODGE THE DEVICE FROM THE TFNA SCREW, BUT THERE IS NO WAY TO NOW REMOVE THE COUPLING DEVICE FROM THE INSERTER. ON THE SAME PATIENT, A TIBIAL NAIL WAS ALSO COMPLETED. WHEN ATTEMPTING TO LOAD THE TNA ONTO THE INSERTION HANDLE, THEY WERE UNABLE TO ATTACH THE NAIL DUE TO THE TABS ON THE ATTACHMENT SITE BEING BENT. IT WOULD NOT ALLOW THE NAIL TO INSERT ONTO THE DEVICE APPROPRIATELY OR FOR THE CONNECTING BOLT TO INSERT TO REQUIRED DEPTH TO ATTACH TO THE TNA NAIL. TO SOLVE THIS ISSUE, THEY OPENED A SECOND TNA SET AND WERE ABLE TO SECURE A NAIL TO THIS DEVICE FOR INSERTION AND COMPLETE THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25116989 ↗
• MalfunctionApr 6, 2026Crack

  IT WAS REPORTED THAT DURING THE DISTAL BLOCKAGE OF THE NAIL, THE TIP OF THE BIT WAS FRACTURED; IT WAS SENT WITH RED TAPE. THE CONNECTING SCREW DOES NOT HOLD THE SPIRAL SHEET WELL: THE THREAD STEP FEELS HARD WHEN ATTEMPTING TO THREAD AND DOES NOT COMPLETE THE TURNS NECESSARY TO HOLD THE SHEET PROPERLY. THE IMPACTOR HANDLE OF THE BLADE IS LOOSE IN THE RUBBER, WHICH MAKES IT DIFFICULT TO HOLD ON IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24790507 ↗
• MalfunctionApr 1, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT DURING FIXATION WITH THE IMPLANT, A FAILURE IN THE COUPLING OF THE CONNECSCR COMPONENT WAS DETECTED, PREVENTING PROPER FASTENING AND CAUSING DAMAGE TO THE SCREW THREAD OF THE TFNA FENESTRATED SCREW. AS A RESULT, THE SCREW COULD NOT BE INSERTED, NECESSITATING REPLACEMENT OF THE IMPLANT TO ENSURE OPTIMAL FIXATION AND CONTINUATION OF THE PROCEDURE. THIS TECHNICAL ISSUE LED TO A PROLONGED SURGICAL TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24756451 ↗
• MalfunctionMar 30, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT TFNA HELICAL-BLADE IMPACT AND HELICAL BLADE/SCREW COUPLING SCREW BECAME STUCK TOGETHER DURING HANDLING AT A CENTRAL STERILE REPROCESSING AREA. THERE WAS NO PATIENT INVOLVEMENT OR IMPACT, AND NO ADVERSE CLINICAL CONSEQUENCES WERE REPORTED. THE DEVICES WERE NOT IN POSSESSION OF THE FACILITY AT THE TIME OF THE EVENT, WITH ONE DEVICE NOTED AS A LOANER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24730132 ↗
• MalfunctionMar 30, 2026Break; Device-Device Incompatibility

  IT WAS REPORTED THAT HELICAL BLADE/SCREW COUPLING SCREW FAILED INTRAOPERATIVELY WHEN A COUPLING SCREW WOULD NOT THREAD INTO THE BACK OF THE BLADE OR SCREW INSERTER. BOTH INSTRUMENTS WITHIN THE TFNA LOCKING SET WERE RENDERED UNUSABLE DUE TO BREAKAGE. THE EVENT DID NOT DELAY SURGERY, AS AN ALTERNATIVE SET WAS AVAILABLE, AND THERE WAS NO PATIENT CONSEQUENCE OR INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24727539 ↗
• MalfunctionMar 30, 2026Break; Device-Device Incompatibility

  IT WAS REPORTED THAT HELICAL BLADE/SCREW COUPLING SCREW FAILED INTRAOPERATIVELY WHEN A COUPLING SCREW WOULD NOT THREAD INTO THE BACK OF THE BLADE OR SCREW INSERTER. BOTH INSTRUMENTS WITHIN THE TFNA LOCKING SET WERE RENDERED UNUSABLE DUE TO BREAKAGE. THE EVENT DID NOT DELAY SURGERY, AS AN ALTERNATIVE SET WAS AVAILABLE, AND THERE WAS NO PATIENT CONSEQUENCE OR INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24727511 ↗
• MalfunctionMar 26, 2026Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT THE SCREW BLADE COUPLING HAS DAMAGE THREADS AND WILL NOT ENGAGE WITH THE BLADE/SCREW INSERTER. THE EVENT OCCURRED PRE-OPERATIVELY WHEN SCRUB TECH WAS SETTING UP FOR A CASE. THERE WAS NO PATIENT INVOLVEMENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24702641 ↗
• MalfunctionMar 11, 2026Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT THE THREADS IN THE INSERTER/COUPLING SCREW ARE DAMAGED AND CAN NO LONGER BE ENGAGED PROPERLY. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24575620 ↗
• MalfunctionMar 11, 2026Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT THE THREADS IN THE INSERTER/COUPLING SCREW ARE DAMAGED AND CAN NO LONGER BE ENGAGED PROPERLY. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24570264 ↗
• MalfunctionMar 6, 2026Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT THE THREADS IN THE MIDDLE OF THE TWO INSTRUMENTS HAVE BECOME DAMAGED AND NOW DON¿T THREAD SMOOTHLY. THERE HAS BEEN NO PATIENT RELATED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24537053 ↗
• MalfunctionFeb 13, 2026Device-Device Incompatibility; Material Twisted/Bent

  AFTER COMPLETING THE SUCCESSFUL INSERTION OF A TFNA NAIL, WHILE REASSEMBLING THE SET AFTER DECONTAMINATION, IT WAS FOUND THAT THE LAG SCREW INSERTOR AND THE LAG SCREW INSERTOR CONNECTING SCREW HAD BECOME INSEPARABLE. DUE TO OVERUSE/GENERAL WEAR AND TEAR, IT SEEMS LIKE THE INTERNAL THREADS CONNECTING THE TWO HAVE BECOME COMPROMISED. THEY WERE ABLE TO BE FORCEFULLY SEPARATED FOR PROPER RE-DECONTAMINATION BUT THE TWO ARE NO LONGER CASE READY. THERE WAS NO PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24333037 ↗
• MalfunctionFeb 11, 2026Break; Crack; Device-Device Incompatibility

  IT WAS REPORTED THAT PRODUCTS WERE UNABLE TO STERILIZE/ASSEMBLE AND ARE CHIPPING AND CRACKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24317563 ↗
• MalfunctionFeb 11, 2026Break; Crack; Device-Device Incompatibility

  IT WAS REPORTED THAT PRODUCTS WERE UNABLE TO STERILIZE/ASSEMBLE AND ARE CHIPPING AND CRACKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24317558 ↗
• MalfunctionFeb 11, 2026Break; Crack; Device-Device Incompatibility

  IT WAS REPORTED THAT PRODUCTS WERE UNABLE TO STERILIZE/ASSEMBLE AND ARE CHIPPING AND CRACKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24317554 ↗
• MalfunctionFeb 3, 2026Break

  IT WAS REPORTED THAT THE THREADS ON INNER CANNULA ARE BROKEN DURING INTRA-OPERATIVE USE. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24248914 ↗
• MalfunctionFeb 2, 2026Device-Device Incompatibility

  COUPLING SCREW WILL NOT ENGAGE WITH LAG SCREW (RIGHT SIDE). THERE WAS NO PATIENT OR USER HARM. THERE WAS NO SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24233116 ↗
• MalfunctionJan 29, 2026Device-Device Incompatibility

  IT WAS REPORTED THE HANDLE SCREWDRIVER AND THE INNER ROD ARE INSEPARABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24212175 ↗

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-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-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-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-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-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-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