NA 03.037.024Recalls & reported problems

Summary

The FDA's MAUDE database contains 120 adverse event reports that list this exact device (DI 10886982070401), received between Jan 20, 2017 and Sep 3, 2026 — classified as 4 injuries, 116 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (85 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 120 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 3, 2026Device-Device Incompatibility; Mechanical Jam

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50594003 ↗
• MalfunctionSep 1, 2026Device-Device Incompatibility

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50547964 ↗
• MalfunctionMay 7, 2026Device-Device Incompatibility

  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 25117037 ↗
• 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 24727664 ↗
• MalfunctionMar 30, 2026Contamination /Decontamination Problem; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2026, THE PATIENT UNDERWENT AN ORIF SURGERY VIA TFNA LONG FOR PROXIMAL TROCHANTERIC FEMORAL FRACTURE WITH THE PRODUCT IN QUESTION. IN THE SURGERY, CEMENT WAS FOUND TO HAVE ADHERED TO THE IMPACTOR'S CONNECTION POINT, MAKING IT IMPOSSIBLE TO INSERT THE CONNECTING SCREW. THE SALES REPRESENTATIVE ADVISED THE SURGEON THAT THEY WOULD EITHER FORCIBLY SCRAPE OFF THE CEMENT OR STERILIZE AND PREPARE ANOTHER TFNA INSTRUMENT. THE SURGEON EVENTUALLY SCRAPED OFF THE CEMENT, REVEALING A POWDER THAT LOOKED LIKE CEMENT, ALLOWING THE CONNECTING SCREW TO BE INSERTED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THE PRODUCT IN QUESTION IS NOT AN INSTRUMENT THAT USES CEMENT. THE SALES REPRESENTATIVE WILL BE PROVIDING FURTHER GUIDANCE TO ENSURE CAREFUL MANAGEMENT OF CEMENT DURING SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24718521 ↗
• 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 24575593 ↗
• 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 24570198 ↗
• 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 24537070 ↗
• 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 24161897 ↗
• MalfunctionDec 22, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT, MULTIPLE HELICAL BLADE INSERTER HANDLES NO LONGER CONNECT PROPERLY TO THE SHAFT. THEY HAVE ALSO WORN DOWN DUE TO WEAR AND TEAR. IT WAS NOTED THERE WAS UNKNOWN AMOUNT OF TIME OF SURGICAL DELAY. NO PATIENT HARM. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23865021 ↗
• MalfunctionDec 22, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED MULTIPLE HELICAL BLADE INSERTER HANDLES NO LONGER CONNECT PROPERLY TO THE SHAFT. THEY HAVE ALSO WORN DOWN DUE TO WEAR AND TEAR. IT WAS NOTED THERE WAS UNKNOWN AMOUNT OF TIME OF SURGICAL DELAY. NO PATIENT HARM. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23865006 ↗
• MalfunctionDec 22, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED MULTIPLE HELICAL BLADE INSERTER HANDLES NO LONGER CONNECT PROPERLY TO THE SHAFT. THEY HAVE ALSO WORN DOWN DUE TO WEAR AND TEAR. IT WAS NOTED THERE WAS UNKNOWN AMOUNT OF TIME OF SURGICAL DELAY. NO PATIENT HARM. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23864863 ↗
• MalfunctionDec 1, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON NOVEMBER 9, 2025 THAT HELICAL BLADE COUPLING SCREW WILL NOT THREAD INTO HELICAL BLADE INSERTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23679955 ↗
• MalfunctionSep 12, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON (B)(6) 2025 THE HELICAL BLADE INSERTED AND CONNECTING ROD FAILED DURING PROCEDURE AND PATIENT HAD TO BE CANCELLED 60MINS INTO THE PROCEDURE WHILE UNDER ANESTHESIA. THE CONNECTING ROD THREAD WAS DAMAGED AND WOULD NOT PASS THROUGH THE INSERTED TO CONNECT TO THE BLADE FOR INSERTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23042441 ↗
• MalfunctionJun 26, 2025Degraded; Contamination /Decontamination Problem; Degraded; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THERE WAS LOSS OF COLOR CODE ON THE INSTRUMENT. IT IS UNKNOWN WHEN THE ISSUE OCCURRED; IT SEEMED TO HAVE HAPPENED IN THE DISHWASHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22338754 ↗
• MalfunctionMay 13, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PRODUCTS IN QUESTION WERE CHECKED AT THEIR DELIVERED TO THE HOSPITAL. IT WAS CONFIRMED THAT THE DIRT CAME OUT FROM THE PRODUCTS IN QUESTION, WHEN THE PRODUCTS HAD WHAT SEEMED LIKE THE BLOOD CHUNK/DIRT IN THE HOLLOW SECTION, THE PRODUCTS WAS WASHED OF THE DIRT. THE SALES REP WAS INFORMED THAT WERE ABLE TO CLEAN THE PRODUCTS AT THE HOSPITAL. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22013971 ↗
• MalfunctionMay 5, 2025Device-Device Incompatibility; Material Twisted/Bent; Mechanical Jam; Device-Device Incompatibility; Material Twisted/Bent; Mechanical Jam

  IT WAS REPORTED THAT AN (B)(6) 2025, THE COUPLING SCREW FOR THE TFNA WAS STUCK IN THE HELICAL BLADE INSERTER AND THE SCRUB TECH WAS NOT ABLE TO GET THE HELICAL BLADE/SCREW COUPLING SCREW TO THREAD INTO THE HELICAL BLADE INSERTER. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE HELICAL BLADE WAS INSERTED OVER THE GUIDE WIRE WITHOUT THE USE OF THE COUPLING SCREW. NO DELAY IN SURGICAL TIME OR NEGATIVE CONSEQUENCES RESULTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21963463 ↗
• MalfunctionMar 7, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT PRIOR TO A PROCEDURE, THE HELICAL BLADE INSERTION HANDLE DID NOT ASSEMBLE. THE EVENT DID NOT OCCUR DURING STERILE PROCESSING, FIELD INSPECTION AND INTERNAL SERVICE ACTIVITIES SUCH AS CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT NOR PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21549550 ↗
• MalfunctionFeb 26, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, THE CONNECTING SCREW WOULD NOT THREAD INTO THE HELICAL BLADE INSERTER PROPERLY DURING SURGERY. THE IMPLANTED HELICAL BLADE WITHOUT THE COUPLING SCREW ATTACHED. THERE WAS A SURGICAL DELAY OF 5 MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21471293 ↗
• MalfunctionJan 6, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THREADED SLEEVE GOT STUCK IN AIMING ARM. THE COUPLING SCREW WAS CATCHING UPON INSERTING INTO HELICAL BLADE INSERTER. THERE WAS NO PATIENT STATUS/OUTCOME/ONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21086309 ↗
• MalfunctionDec 10, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO ALLEGATION AGAINST THE HELICAL BLADE/LAG SCREW COUPLING SCREW. NO LABORATORY TESTS WERE TAKEN DUE TO THE CLINICAL FINDINGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20892005 ↗
• MalfunctionDec 6, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A TRAUMA PROCEDURE, THE TFNA BLADE WAS CONNECTED TO THE INSERTER. TIGHTENED COUPLING SCREW AND ATTEMPTED TO TEST WITH GUIDE WIRE, BUT GUIDE WIRE WOULD NOT PASS THROUGH. RESET EVERYTHING AND TRIED AGAIN AND STILL FAILED. SURGEON MADE DECISION TO SWAP TO A TFNA SCREW, WHICH USES A DIFFERENT INSERTER, AND COMPLETED THE PROCEDURE. SURGERY WAS DELAYED BY FIVE MINUTES DUE TO THE EVENT, AND WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20869250 ↗
• MalfunctionOct 29, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A TFNA CASE, THE HELICAL BLADE INSERTER AND COUPLING SCREW WOULD NOT DETACH FROM THE HELICAL BLADE. THE SURGEON AND SCRUB TECH USE THE FLEXIBLE SCREWDRIVER AND PIN WRENCH TO UNTHREAD THE COUPLING SCREW, BUT IT WOULD NOT BUDGE. HE THEN TRIED TO UNCOUPLE THE SCREW AND INSERTER FROM THE HELICAL BLADE AFTER THE CASE, AND EVEN HE COULD NOT GET IT OUT. THE CASE WAS DELAYED 5 MINUTES BECAUSE STAFF HAD TO OPEN A SECOND TFNA LOCKING TRAY FOR A SECOND HELICAL BLADE INSERTER AND HAD TO OPEN A SECOND IMPLANT. THERE WERE NO PATIENT CONSEQUENCES, AND THE PROCEDURE PROCEEDED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20561529 ↗
• MalfunctionOct 11, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024. DURING SURGERY, IT BECAME EVIDENT THAT THE CONNECTION SCREW AND THE IMPACTING PIECE OF THE HELICAL BLADE ARE IN POOR CONDITION, PREVENTING THE IMPLANT FROM BEING CONNECTED CORRECTLY. THIS REPORT IS FOR A HELICAL BLADE INSERTER.

  Patient problems: Insufficient Information

  MAUDE report 20433066 ↗
• MalfunctionOct 3, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024 DURING A PROCEDURE USING A TFNA, THERE WAS AN ISSUE WITH THE TRIPLE SLEEVE FOR THE LAG SCREW AND THE HELICAL BLADE INSERTER. AFTER INSERTING THE NAIL, THE AIMING ARM WAS ATTACHED AND THEN THE TRIPLE SLEEVE FOR THE BLADE. THE WIRE WAS INSERTED, MEASURED, DRILLED AND THEN WENT TO INSERT THE BLADE AND IT WOULD NOT PASS THROUGH THE TRIPLE SLEEVE. THE TRIPLE SLEEVE WAS PULLED OUT AND TRIED PASSING THE WIRE GUIDE BACK THROUGH AND IT WOULD ALSO NO LONGER PASS THROUGH THE TRIPLE SLEEVE. NO OTHER INFORMATION WAS PROVIDED AT THIS TIME. THIS REPORT INVOLVES ONE HELICAL BLADE INSERTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20360515 ↗

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-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-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-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