NA 03.037.025Recalls & reported problems

Summary

The FDA's MAUDE database contains 119 adverse event reports that list this exact device (DI 10886982070418), received between Jan 11, 2017 and Sep 30, 2026 — classified as 119 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (95 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 119 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Device Slipped; Device-Device Incompatibility

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949943 ↗
• 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 50841575 ↗
• 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 50754695 ↗
• MalfunctionSep 8, 2026Device-Device Incompatibility

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50671962 ↗
• 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 25116980 ↗
• MalfunctionApr 21, 2026Break; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE THREADS OF THE SCREW INSERTER WAS DAMAGED/CHIPPED. THE GUIDE SLEEVE WAS NOT PASSING THROUGH THE SLEEVE SMOOTHLY. THERE WAS NO OPERATION AND PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24937454 ↗
• MalfunctionFeb 25, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT LAG SCREW INSERTER WOULD NOT PAIR WITH LAG SCREW. THERE WAS A 5 MINUTES OF SURGICAL DELAY DUE TO THE REPORTED EVENT. A DIFFERENT INSERTER WAS USED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24447063 ↗
• 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 24333036 ↗
• MalfunctionFeb 5, 2026Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT DURING SURGERY, WHILE MOUNTING THE TFNA DRILLED SCREW ONTO THE INSTRUMENT DESIGNED FOR THIS PURPOSE, DIFFICULTY AROSE DUE TO A SLIGHT DEFORMITY OBSERVED AT THE TIP OF THE TFNA SCREW INSERT, WHICH PREVENTED EASY ASSEMBLY. AFTER SEVERAL ATTEMPTS, THE SPECIALIST SUCCESSFULLY PRESSED IT INTO PLACE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24273681 ↗
• 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 24212631 ↗
• MalfunctionJan 13, 2026Break; Material Twisted/Bent

  IT WAS REPORTED THAT MULTIPLE TRAYS HAD COMPONENTS/INSTRUMENTS THAT WERE STARTING TO BREAK APART AND SHEDDING PIECES WITH NOT IN USABLE CONDITION DURING THE SPD STERILIZATION PROCESS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24059242 ↗
• MalfunctionJan 13, 2026Break; Material Twisted/Bent

  IT WAS REPORTED THAT MULTIPLE TRAYS HAD COMPONENTS/INSTRUMENTS THAT WERE STARTING TO BREAK APART AND SHEDDING PIECES WITH NOT IN USABLE CONDITION DURING THE SPD STERILIZATION PROCESS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24059236 ↗
• MalfunctionJan 13, 2026Break; Material Twisted/Bent

  IT WAS REPORTED THAT MULTIPLE TRAYS HAD COMPONENTS/INSTRUMENTS THAT WERE STARTING TO BREAK APART AND SHEDDING PIECES WITH NOT IN USABLE CONDITION DURING THE SPD STERILIZATION PROCESS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24059221 ↗
• MalfunctionDec 22, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE INSTRUMENTS USED IN CONJUNCTION WERE FOUND TO BE NOT ALLOWING ATTACHMENT OF IMPLANT WHEN ASSEMBLED FOR SURGERY. A SECOND SET OF INSTRUMENTS WERE USED PRIOR TO IMPLANTATION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23865358 ↗
• MalfunctionDec 4, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON (B)(6) 2025 THAT THE TFNA LAG SCREW NOT LOCKING INTO FIXED ANGLE AFTER TIGHTENING SET SCREW. PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WAS NO DELAY IN SURGERY DUE TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23720484 ↗
• MalfunctionNov 18, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED ON (B)(6) 2025 THAT THE COUPLING SCREW FOR THE LAG SCREW INSERTER WAS CROSS THREADED INTO THE LAG SCREW INSERTER AND UNABLE TO BE REMOVED. PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FRAGMENTS WERE GENERATED. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23583797 ↗
• MalfunctionNov 3, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, WHEN INSERTING A LAG SCREW, THE SCREW STRIPPED ON THE SCREWDRIVER. WE TRIED TO EXTRACT BUT THE SCREWDRIVER BECAME STUCK IN THE SLEEVE AND COULDN¿T BE REMOVED. THE ENTIRE SLEEVE/SCREWDRIVER CONSTRUCT WAS REMOVED AND ANOTHER PAN WAS OPEN TO FINISH THE CASE. THERE WAS 5 MIN SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23456355 ↗
• MalfunctionNov 3, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE IMPACTOR NAIL BROKE OFF IN JIG. THE FRAGMENT REMAINED STUCK IN THE JIG. THE PATIENT DID NOT RETAIN ANY FRAGMENTS. THE TFNA LAG SCREW SCREWDRIVER BURRED SO IT¿S NOT RETAINING VERY WELL. THERE WAS A SURGICAL DELAY OF FIVE (5) MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23450505 ↗
• MalfunctionOct 22, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT THE THREADS THAT ARE PRESENT ON THE HELICAL BLADE/SCREW COUPLING SCREW ARE STRIPPED AND THUS, DO NOT THREAD CORRECTLY INTO THE INTERNAL THREADS OF THE TFNA SCREW INSERTER. THE INTERNAL THREADS OF THE TFNA SCREW INSERTER MAY ALSO BE STRIPPED BUT IS HARD TO TELL FOR CERTAIN SINCE THEY ARE INTERNAL. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23358988 ↗
• MalfunctionOct 21, 2025Break; Crack; Device-Device Incompatibility; Break; Crack; Device-Device Incompatibility

  IT WAS REPORTED THAT DEVICE WAS UNABLE TO STERILIZE/ASSEMBLE. IT WAS CHIPPING AND CRACKING AND WAS UNABLE TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23352236 ↗
• MalfunctionOct 21, 2025Break; Crack; Device-Device Incompatibility; Break; Crack; Device-Device Incompatibility

  IT WAS REPORTED THAT DEVICE WAS UNABLE TO STERILIZE/ASSEMBLE. IT WAS CHIPPING AND CRACKING AND WAS UNABLE TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23352001 ↗
• MalfunctionAug 27, 2025Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22903203 ↗
• MalfunctionAug 21, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING SURGERY, IT WAS NOTED THAT THE TFNA INSERTER WAS DAMAGED AND NO LONGER FITS THE SCREW. IT IS NOT BROKEN, STILL INTACT, BUT WILL NOT FIT THE SCREW ONTO IT; IT HAS BLACK MARKINGS ON THE TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22859263 ↗
• MalfunctionAug 18, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2025, THE ITEM DID NOT MATCHING UP WITH LAG SCREW, APPEARED TO BE BENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22835380 ↗
• MalfunctionJul 9, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) FENESTRATED SCREW WILL NOT SEAT PROPERLY ON HANDLE. THERE WAS NO SURGICAL DELAY AND NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22459047 ↗

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-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-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-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