NA 03.037.011Recalls & reported problems

Summary

The FDA's MAUDE database contains 106 adverse event reports that list this exact device (DI 10886982070272), received between Jan 26, 2017 and May 1, 2026 — classified as 3 injuries, 103 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (68 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 106 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 1, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE OUTER DRILL BIT HIT THE NAIL AND METAL SHAVINGS WERE GENERATED. THE INSERTION HANDLE AND OUTER AIMING ARM ARE NOT HOLDING ALIGNMENT CORRECTLY LEADING TO THE DRILL BIT HITTING THE NAIL, AND CAUSING A SURGICAL DELAY. THE ORIGINAL NAIL WAS DISCARDED, A NEW NAIL WAS INSERTED, AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25058212 ↗
• MalfunctionApr 30, 2026Use of Device Problem; Device-Device Incompatibility

  IT WAS REPORTED THAT SURGEON EXPRESSED A PREFERENCE FOR THE TFNA HYBRID HANDLE OVER HYBRID HANDLE DUE TO ITS CARBON METAL EXTENDING HIGHER THAN THE CONNECTION POINT BETWEEN NAIL AND HANDLE AND FOR MORE STABILITY WHILE HOLDING ONTO THE NAIL IN LARGER PATIENTS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25050430 ↗
• MalfunctionApr 30, 2026Use of Device Problem; Device-Device Incompatibility

  IT WAS REPORTED THAT SURGEON EXPRESSED A PREFERENCE FOR THE TFNA HYBRID HANDLE OVER HYBRID HANDLE DUE TO ITS CARBON METAL EXTENDING HIGHER THAN THE CONNECTION POINT BETWEEN NAIL AND HANDLE AND FOR MORE STABILITY WHILE HOLDING ONTO THE NAIL IN LARGER PATIENTS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25049518 ↗
• 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 25028112 ↗
• MalfunctionApr 6, 2026Break

  IT WAS REPORTED THAT THE COMBINED HAMMER 500G AND INSERT-HANDLE HYBRID WERE INVOLVED IN AN INTRA-OPERATIVE EVENT. THE HAMMER BROKE WHILE INSERTING A NAIL, AND A DIFFERENT HAMMER WAS USED, WHICH DID NOT ALLOW BACKSLAPPING. THIS LED TO THE INSERTION HANDLE BEING STRUCK AND SUBSEQUENTLY DAMAGED. THERE WAS NO REPORTED PATIENT HARM OR SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24789326 ↗
• 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) 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 24774686 ↗
• 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 24756465 ↗
• MalfunctionMar 9, 2026Break

  IT WAS REPORTED ON AN UNKNOWN DATE, THE NAIL INSERTION HANDLE AND IMPACTOR WERE BROKEN DURING THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24545282 ↗
• MalfunctionMar 5, 2026Device-Device Incompatibility

  ADDITIONAL INFORMATION RECEIVED: A. DO YOU BELIEVE THIS IS AN INSTRUMENTATION ISSUE OR USER ERROR? - INSTRUMENT ISSUE. B. HOW WAS IT RESOLVED? - OPENED A DIFFERENT SET. C. DID THIS OCCUR DURING SURGERY? - YES. D. WAS THERE ANY SURGICAL DELAY DUE TO THE REPORTED EVENT? IF YES, HOW LONG? - NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24520184 ↗
• MalfunctionFeb 23, 2026Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED DURING ROUTINE MEDICAL DEVICE REPROCESSING, MEDICAL DEVICES REPROCESSING STAFF IDENTIFIED ISSUES WITH 3 INSTRUMENTS: THE THREADS OF INSTRUMENT 03.010.523 WERE FOUND TO BE STRIPPED BADLY, AND UPON TESTING WOULD NO LONGER THREAD INTO INSTRUMENT 03.037.011. IT WAS IDENTIFIED THAT THE INNER THREADS OF COMPLAINED ITEM 03.037.011 WERE STRIPPED AND WOULD NOT ACCEPT THE MATING THREADS OF COMPLAINED INSTRUMENT 03.010.523. IN ADDITION, THE UNDERSIDE OF THE CARBON FIBRE HANDLE OF ITEM 03.037.011 WAS IDENTIFIED TO BE ROUGH, SHARP AND JAGGED. IN ADDITION, IT WAS IDENTIFIED THAT THE INNER BALL BEARING CONTAINED WITHIN COMPLAINED ITEM 03.010.072 WAS MISSING, RENDERING THE INSTRUMENT TO BE NO LONGER FUNCTIONAL. EACH OF THE AFOREMENTIONED COMPLAINED ITEMS WAS DEEMED TO BE NO LONGER FUNCTIONAL AND THEY WERE EACH SUBSEQUENTLY DISCARDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24416227 ↗
• MalfunctionJan 22, 2026Device-Device Incompatibility

  ADDITIONAL INFORMATION RECEIVED: A. KINDLY RE-CONFIRM WHAT IS THE TIMING OF THE REPORTED EVENT? (PRE-OP, INTRA-OP, POST-OP) -POST- OP.

  Patient problems: Insufficient Information

  MAUDE report 24146430 ↗
• MalfunctionJan 13, 2026Contamination /Decontamination Problem; Device-Device Incompatibility

  IT WAS REPORTED THAT THE HYBRID INSERTION HANDLE DID NOT WORK PROPERLY DURING A PROCEDURE. THE INSERTION ARCH WAS NOTED TO BE IN MOTION, AND THE ENGINE WAS DESCRIBED AS LACKING FORCE. UPON COMPLETION OF THE SURGERY, THE RECOMMENDATIONS WERE MADE TO USE AN ANTI-ROTATIONAL GUIDE THROUGH THE ARM TO PREVENT SUCH MOVEMENT DUE TO THE WIDE CANAL, BUT THE REPORTING PHYSICIAN WAS DISSATISFIED WITH THIS SOLUTION. A BIT WITH BONE TISSUE WAS ALSO OBSERVED PRIOR TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24056153 ↗
• MalfunctionJan 13, 2026Contamination /Decontamination Problem; Device-Device Incompatibility

  IT WAS REPORTED THAT THE HYBRID INSERTION HANDLE DID NOT WORK PROPERLY DURING A PROCEDURE. THE INSERTION ARCH WAS NOTED TO BE IN MOTION, AND THE ENGINE WAS DESCRIBED AS LACKING FORCE. UPON COMPLETION OF THE SURGERY, THE RECOMMENDATIONS WERE MADE TO USE AN ANTI-ROTATIONAL GUIDE THROUGH THE ARM TO PREVENT SUCH MOVEMENT DUE TO THE WIDE CANAL, BUT THE REPORTING PHYSICIAN WAS DISSATISFIED WITH THIS SOLUTION. A BIT WITH BONE TISSUE WAS ALSO OBSERVED PRIOR TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24056151 ↗
• 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 24055291 ↗
• MalfunctionJan 12, 2026Device-Device Incompatibility; Material Twisted/Bent

  DURING A PROCEDURE, THE TFNA STRIKE PLATE AND INSERTION HANDLE THREADS CROSSED AND STUCK TOGETHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24037486 ↗
• MalfunctionDec 26, 2025Break; No Apparent Adverse Event; Break; No Apparent Adverse Event

  IT WAS REPORTED WHILE INSERTING A TFNA NAIL THE DRIVING CAP BROKE OFF AND WAS STUCK IN THE HYBRID INSERTION HANDLE. THERE WAS NO SURGICAL DELAY OR HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23897836 ↗
• 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 23887329 ↗
• MalfunctionNov 13, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A FEMORAL NAILING PROCEDURE, THE TFNA AIMING ARM WAS NOT ALIGNED WITH THE SHORT NAIL CAUSING THE 4.2 DRILL BIT TO SKIVE WHEN DRILLING THE DISTAL LOCKING HOLE. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23542918 ↗
• MalfunctionNov 11, 2025Break; Break

  IT WAS REPORTED THAT THE HANDLE WAS BROKEN AND REQUIRED REPAIR/REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23522979 ↗
• MalfunctionOct 15, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON (B)(6) 25 AT 2PM DOCTOR REPORTED DIFFICULTY INSERTION OF IM NAIL WITH INSERTION HANDLE RESULTING IN HAVING TO EXTEND INCISION ON PATIENT. OUR DESIGN HAS SINCE BEEN UPDATED TO A LESS ¿BULKY DESIGN¿ AND BELIEVE THIS SHOULD ALLEVIATE THE ISSUE. SAME SURGERY THE IMPLANT NEED TO BE REMOVED AND REINSERTED; EXTRACTION BOLT APPEARS TO BE STRIPPED AS IT WAS DIFFICULT TO THREAD INTO THE IMPLANT. CUMULATIVE TIME ADDED TO PREFORM THE SURGERY ESTIMATED AT 20-30 MINUTES. NO HARDWARE WAS RETAINED AND NO OTHER ISSUES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23300213 ↗
• MalfunctionOct 15, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE DOCTOR REPORTED THERE WAS DIFFICULTY WITH THE INSERTION OF AN IM NAIL WITH INSERTION HANDLE RESULTING IN HAVING TO EXTEND THE INCISION ON THE PATIENT. THE DESIGN HAD SINCE BEEN UPDATED TO A LESS ¿BULKY DESIGN¿ AND BELIEVED TO HAVE ALLEVIATED THIS ISSUE. IN THE SAME SURGERY, THE IMPLANT NEEDED TO BE REMOVED AND REINSERTED; EXTRACTION BOLT APPEARS TO BE STRIPPED AS IT WAS DIFFICULT TO THREAD INTO THE IMPLANT. CUMULATIVE TIME ADDED TO PERFORM THE SURGERY IS ESTIMATED AT TWENTY TO THIRTY MINUTES. NO HARDWARE WAS RETAINED AND NO OTHER ISSUES REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 23292451 ↗
• MalfunctionOct 15, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT DURING MEDICAL DEVICE REPROCESSING A STAFF NOTICED MULTIPLE ISSUES WITH DEVICES. NO WIRES ARE ABLE TO BE PASSED THROUGH THE WIRE GUIDE SLEEVES. IT SEEMS LIKE THE INNER METAL IS BURRED AND PREVENTING THE PROPER PASSAGE OF WIRES. THE TFNA INSERTION HANDLE HAS BEEN CROSS THREADED AND NO AIMING ARM IS ABLE TO BE THREADED INTO THE ATTACHMENT SLOT. NO DRILL STOPS WILL STAY LOCKED INTO THE CANNULATED STEP DRILL BITS. THERE IS ABNORMALLY LARGE SPACE BETWEEN SEGMENTS OF THE FLEXIBLE DRILL BITS WHICH CAUSES A WOBBLE WHEN USED ON POWER TO OPEN THE FEMUR FOR NAIL INSERTION. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23286539 ↗
• MalfunctionJul 9, 2025Break; Corroded; Material Discolored; Material Deformation; Break; Corroded; Material Discolored; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE ITEMS ARE WARPED, THREADS ARE BROKEN AND ARE RUSTED. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22461416 ↗
• MalfunctionJul 9, 2025Break; Corroded; Material Discolored; Material Deformation; Break; Corroded; Material Discolored; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE ITEMS ARE WARPED, THREADS ARE BROKEN AND ARE RUSTED. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22461396 ↗
• MalfunctionJul 9, 2025Break; Corroded; Material Deformation; Break; Corroded; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE ITEMS ARE WARPED, THREADS ARE BROKEN AND ARE RUSTED. THERE WAS NO PATIENTS CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22459578 ↗

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