NA 03.037.010Recalls & reported problems

Summary

The FDA's MAUDE database contains 168 adverse event reports that list this exact device (DI 10886982070265), received between Jan 23, 2017 and Sep 21, 2026 — classified as 6 injuries, 162 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (136 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 168 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 50841721 ↗
• 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 50841677 ↗
• 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 50841651 ↗
• 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 50755264 ↗
• 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 50753714 ↗
• MalfunctionApr 29, 2026Device-Device Incompatibility

  IT WAS REPORTED DURING A TFNA PROCEDURE, SURGEON USED THE TORQUE SCREWDRIVER TO LOCK THE SET SCREW IN THE NAIL, BUT ONLY AFTER A FEW TURNS THE CLICK SOUND FROM THE TORQUE WAS HEARD. CHECKED THROUGH I/I TO SEE IF THE SET SCREW WAS LOCKED IN PLACE BUT THE SET SCREW CAN BE SEEN THAT IT WAS STUCK AT THE TOP OF THE NAIL. TRIED USING BOTH THE FLEXIBLE SCREWDRIVER AND TORQUE SCREWDRIVER BUT UNABLE TO LOCK DOWN THE SET SCREW. IT REMAINED STUCK AT THE TOP OF THE NAIL. HAD TO TAKE OUT THE BLADE AND THEN THE NAIL OUT OF THE PATIENT BEFORE TRYING TO UNLOCK/LOCK THE SET SCREW FROM THE STERILE FIELD USING BOTH SCREWDRIVER BUT STILL FAILED. AND THE AIMING ARM AND CONNECTING SCREW WAS STUCK WITH THE NAIL, UNABLE TO REMOVE. SURGEONS DECIDED TO CHANGE TO A DIFFERENT NAIL. SURGERY WAS DELAYED FOR 30MINS, ANOTHER SET OF IMPLANT WAS AVAILABLE. PATIENT WAS WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25028183 ↗
• MalfunctionApr 3, 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 24774747 ↗
• MalfunctionApr 3, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A TFNA PROCEDURE, THE HELICAL BLADE MISSED THE NAIL. NOT ENTIRELY SURE WHAT HAPPENED BUT DOCTOR ASKED TO REPLACE BOTH HYBRID TFNA HANDLES, FOUR (4) CONNECTING SCREWS, TWO (2) AIMING ARMS , AND TWO (2) WRENCHES. THIS COMPLAINT IS RELATED TO PC-(B)(4) WHICH CAPTURES ADDITIONAL REPORTED DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24774577 ↗
• MalfunctionApr 1, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A TFNA PROCEDURE, THE HELICAL BLADE MISSED THE NAIL. NOT ENTIRELY SURE WHAT HAPPENED BUT DOCTOR ASKED TO REPLACE BOTH HYBRID TFNA HANDLES, FOUR (4) CONNECTING SCREWS, TWO (2) AIMING ARMS, AND TWO (2) WRENCHES. THIS COMPLAINT IS RELATED TO (B)(4) WHICH CAPTURES ADDITIONAL REPORTED DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24755551 ↗
• MalfunctionApr 1, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A TFNA PROCEDURE, THE HELICAL BLADE MISSED THE NAIL. NOT ENTIRELY SURE WHAT HAPPENED BUT DOCTOR ASKED TO REPLACE BOTH HYBRID TFNA HANDLES, FOUR (4) CONNECTING SCREWS, TWO (2) AIMING ARMS, AND TWO (2) WRENCHES. THIS COMPLAINT IS RELATED TO (B)(4) WHICH CAPTURES ADDITIONAL REPORTED DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24755545 ↗
• MalfunctionJan 13, 2026Device-Device Incompatibility

  IT WAS REPORTED ON (B)(6) 2025 THE PATIENT UNDERWENT AN ORIF FOR ATYPICAL FEMORAL FRACTURE USING TFNA. A FINAL POST-OPERATIVE X-RAY REVEALED THE PROXIMAL FENESTRATED BLADE HAD NOT PASSED THROUGH THE NAIL; THE SURGEON REMOVED THE BLADE AND INSERTED IT INTO THE NAIL. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN A SIXTY (60) MINUTE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24055467 ↗
• MalfunctionJan 12, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE CONNECSCR F/INSERTION HANDLE AND AIM-ARM 125° F/STAT+DYN DIST LOCK WERE UNABLE TO BE ASSEMBLED OR DISASSEMBLED DURING A PRESENTATION. SPECIFICALLY, THE CONNECSCR F/INSERTION HANDLE COULD NOT CONNECT TO A BALL SCREWDRIVER, AND THE AIM-ARM 125° F/STAT+DYN DIST LOCK COULD NOT LOCK A PROTECTIVE SLEEVE ON THE VIEWFINDER. THERE WAS NO PATIENT INVOLVEMENT OR CLINICAL IMPACT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24043889 ↗
• MalfunctionDec 24, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THE SURGEON EXPERIENCED DIFFICULTY TIGHTENING THE LOCKING MECHANISM ONTO THE BLADE SURFACE. THE STATIS LOCKING SCREWDRIVER ASSEMBLY WAS PASSED THROUGH THE INSERTION HANDLE, BUT IT WAS UNCERTAIN WHETHER IT HAD FULLY ENGAGED THROUGH THE CANNULATED CONNECTING SCREW. THE SURGEON SUSPECTED IT WAS NOT PROPERLY SEATED IN THE HEXAGONAL RECESS OF THE LOCK DRIVE, AS CLOCKWISE ADVANCEMENT WAS NOT POSSIBLE. MULTIPLE ATTEMPTS WERE MADE USING BOTH THE FLEXIBLE SCREWDRIVER (03.037.028) AND THE 5 MM HEXAGONAL SCREWDRIVER SHAFT (03.027.029), BUT WITHOUT SUCCESS. THE SURGEON THEN ATTEMPTED A FEW LIGHT MALLET TAPS TO HELP ENGAGE THE LOCK DRIVE, WHICH ALSO FAILED. THE SURGEON DECIDED TO REMOVE THE NAIL FOR INSPECTION. HOWEVER, WHEN ATTEMPTING TO DETACH THE HEXAGONAL SCREWDRIVER SHAFT, IT COULD NOT BE DISCONNECTED FROM THE INSERTION HANDLE. AS A RESULT, THE ENTIRE CONSTRUCT (HEXAGONAL SCREWDRIVER SHAFT, INSERTION HANDLE, AND NAIL) HAD TO BE REMOVED AS ONE PIECE. THE SURGEON PROCEEDED WITH A SECOND INSTRUMENT SET AND A NEW NAIL. USING THE SAME STEPS, THE SURGEON WAS ABLE TO ADVANCE THE LOCKING MECHANISM SUCCESSFULLY WITH THE 5 MM FLEXIBLE SCREWDRIVER PASSED THROUGH THE CONNECTING SCREW A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23889300 ↗
• MalfunctionDec 4, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON UNKNOWN DATE, THE PATIENT UNDERWENT ORIF SURGERY. IT WAS DIFFICULT TO GET THE TFNA CONNECTING SCREW TO FIT. THE SCREW WAS USED IN THE SURGERY AND DID NOT CAUSE ANY PROBLEMS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23720221 ↗
• MalfunctionDec 4, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON UNKNOWN DATE, THE PATIENT UNDERWENT ORIF SURGERY. IT WAS DIFFICULT TO GET THE TFNA CONNECTING SCREW TO FIT. THE SCREW WAS USED IN THE SURGERY AND DID NOT CAUSE ANY PROBLEMS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23720220 ↗
• 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 23639026 ↗
• 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 23639023 ↗
• MalfunctionOct 22, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON (B)(6) 2025 THAT THE CONNECTING BOLT BELIEVED TO BE COLD WELDED ON THE NAIL AND WAS UNABLE TO REMOVE THE NAIL FROM THE AIMING ARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23358325 ↗
• MalfunctionSep 2, 2025Break; Break

  IT WAS REPORTED ON AN UNKNOWN DATE, THE CONNECTING SCREWS BROKE. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22939638 ↗
• MalfunctionSep 2, 2025Break; Break

  IT WAS REPORTED ON AN UNKNOWN DATE, THE CONNECTING SCREWS BROKE. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22939105 ↗
• MalfunctionSep 2, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE CONNECTING SCREW WAS FULL AND DID NOT CONNECT TFNA IMPLANT TO THE AIMING ARM PROPERLY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22938935 ↗
• MalfunctionJun 24, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE CONNECTING SCREW FAILED TO CONNECT TFNA TO AIMING ARM SUCCESSFULLY. THERE WERE MULTIPLE ATTEMPTS TO REFIT BUT IT WOULDN'T WORK. A SECOND DEVICE FROM THE SET WAS USED WITH NO ISSUE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A FIVE MINUTE DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22318262 ↗
• InjuryMay 2, 2025Device-Device Incompatibility; Scratched Material; Device-Device Incompatibility; Scratched Material

  IT WAS REPORTED THAT DURING THE PROCEDURE THE IMPLANTS WERE DAMAGED AND WHEN SURGEON TRIED TO REMOVE THE INSTRUMENT, IT WAS IMPOSSIBLE TO RELEASE THE NAIL FROM THE INSTRUMENT, SO HE HAD TO REMOVE ALL THE IMPLANTS AND LEAVE THE PATIENT WITH THE INITIAL INJURY. SURGEON PLANNED TO REOPERATE PATIENT ON (B)(6) 2025. ADDITIONALLY, WHEN REVIEWING THE NEW PARTS INVOLVED IN THE SURGERY PERFORMED, IT WAS NOTICED THAT THE INSERTION ARCH WAS FUSED TO THE TFNA NAIL BY MEANS OF THE CONNECTION SCREW FOR THE INSERTION ARCH AND HAS INTERNAL SCRATCHES, ALONG WITH THE IMPLANTS THAT WERE REMOVED DUE TO THIS NEW PART. IT WAS IMPOSSIBLE TO DISASSEMBLE THE INSERTION ARCH AND THE NAIL TO SUCH AN EXTENT THAT THE T-HEAD SCREWDRIVER THAT SECURES THE CONNECTING SCREW BROKE.

  Patient problems: Insufficient Information

  MAUDE report 21949085 ↗
• MalfunctionApr 28, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE ANTI ROTATION PINS HIT THE NAIL, THE OPENING REAMER FOR LAG SCREW HIT THE NAIL, AND REAMED PART OF NAIL. THERE WAS NO PATIENT STATUS/ OUTCOME / CONSEQUENCES. ORIGINAL COMPLAINT IN (B)(4) INVOLVES 27 PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21919714 ↗
• MalfunctionApr 28, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE ANTI ROTATION PINS HIT THE NAIL, THE OPENING REAMER FOR LAG SCREW HIT THE NAIL, AND REAMED PART OF NAIL. THERE WAS NO PATIENT STATUS/ OUTCOME / CONSEQUENCES. ORIGINAL COMPLAINT IN (B)(4) INVOLVES 27 PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21919659 ↗

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-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