NA 03.037.114Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10886982344380), received between May 10, 2017 and Jan 13, 2026 — classified as 3 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (10 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• 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 24055325 ↗
• 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 24043990 ↗
• MalfunctionDec 12, 2024Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE ARE NO PIECES IN THE PATIENT. THE SURGEON CONFIRMED BY X-RAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20914644 ↗
• MalfunctionJul 17, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT AN ORIF SURGERY FOR A FEMORAL TROCHANTERIC FRACTURE. THE SURGEON INSERTED THE NAIL IN QUESTION BY HAMMERING BUT GAVE UP HALFWAY THROUGH ITS INSERTION. THE SURGEON REMOVED THE NAIL AND DONE REAMING UNTIL 11 MM. THE DRILL BIT FOR LOCKING SCREWS INTERFERED WITH THE NAIL, BUT THE SURGEON CONTINUED THE SURGERY. AFTER INSERTION OF THE END CAP, THE LOCKING SCREW WAS FOUND TO BE INSERTED OUT OF THE HOLE TOWARD THE ANTERIOR FEMUR. THE SURGEON REMOVED THE LOCKING SCREW AND END CAP, REATTACHED THE INSERTION HANDLE, DRILLED AT THE DYNAMIC HOLE, AND SUCCEEDED IN INSERTING THE LOCKING SCREW WITHOUT INTERFERENCE. THE ASSISTANT SURGEON PRESUMED THAT THE HAMMERING DURING NAIL INSERTION LOOSENED THE SCREWS ON THE AIMING ARM, WHICH MAY HAVE CAUSED THE LOCKING SCREW TO BE INSERTED OUT OF THE HOLE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. THIS REPORT INVOLVES ONE (1) 125 DEG AIMING ARM STATIC+DYNAMIC. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19766341 ↗
• MalfunctionJul 10, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT OSTEOSYNTHESIS FOR TROCHANTERIC FRACTURE. TO ADOPT TO CENTER POSITION, A SURGEON ATTEMPTED TO INSERT A GUIDEWIRE INTO THE AIMED POSITION OF BONEHEAD, HE ALSO ATTEMPTED TO INSERT A BLADE AS WELL. IMAGE INTENSIFIER DISCOVERED THAT THE GUIDE WIRE AS WELL AS THE BLADE WERE LOCATED AT FRONT POSITION AND THEY WERE MISALIGNED FROM MORE THAN 1CM FORWARD, INSTEAD OF STAYING CENTER LOCATION WHERE WAS THE TARGETED POSITION. EVEN THOUGH THE SURGEON REPEATEDLY CHECKED CONDITION TO MAKE SURE THE INSERTED GUIDEWIRE WAS ON CENTER POSITION OF BONEHEAD BEFORE HE INSERTED THE BLADE, FOR SOME REASON THE BLADE WAS POSITIONED AT NONINTENTIONAL PLACE. SINCE THE SITUATION WAS NOT ALLOWED, THE BLADE WAS DETACHED ONCE, AND IT WAS REINSERTED. AS FOR THE SECOND TRY, THE SURGEON INSERTED SLOWLY CAREFULLY WHILE HE WAS CONSTANTLY VIEWING TRUE-LATERAL SIDE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH MORE THAN EXTRA 30 MINUTES. THE REASON WHY EXTRA SURGICAL TIME OCCURRED WAS TO RAMP UP FIXATION CAPACITY FOR REINSERTION, AN UNEXPECTED VOLUME OF CEMENT WAS NEEDED AND IT WAS ADDED. THE PATIENT WAS REPORTED AS STABLE. THIS REPORT INVOLVES ONE 125 DEG AIMING A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19713193 ↗
• MalfunctionSep 19, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2022, THAT THE PROXIMAL LOCKING GUIDE IS RELEASED. FAILED TO PERFORM ANTI-ROTATIONAL LOCK THE PROCEDURE WAS NOT DELAY DUE TO THE EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) AIM-ARM 125° F/STAT+DYN DIST LOCK THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15447019 ↗
• MalfunctionAug 30, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT THE ORIF SURGERY FOR TROCHANTERIC FRACTURE OF FEMUR. A GUIDE WIRE FOR HEAD ELEMENTS SEEMED TO INTERFERE WITH THE NAIL WHEN THE SURGEON WAS INSERTING THE GUIDE WIRE USING THE INSERTION HANDLE AND AIMING ARM. THE SURGEON TRIED INSERTING THE GUIDE WIRE BY PUSHING IT A LITTLE STRONGER, THEN THE GUIDE WIRE GOT STUCK AND COULD NOT BE REMOVED. BUT THE SURGEON MANAGED TO REMOVE THE GUIDE WIRE AND TRIED TO INSERT ANOTHER NEW GUIDE WIRE AFTER CHECKING THE CONNECTION BETWEEN THE INSTRUMENTS AND REVERSED THE LOCKING MECHANISM OF THE NAIL TO REDUCE THE RISK OF INTERFERENCE. THE SURGEON MANAGED TO SUCCEED IN INSERTING THE GUIDE WIRE. AFTER THAT, THE SURGEON ALSO HAD A DIFFICULTY IN USING A REAMER WITH THE INSERTION HANDLE AND AIMING ARM. ALTHOUGH THE REAMER WENT FORWARD ONLY A LITTLE, IT STILL WENT FORWARD TO SOME EXTENT, SO THE SURGEON TRIED TO INSERT A BLADE. HOWEVER, EVEN WHEN THE SURGEON MANUALLY PUSHED THE BLADE, IT DID NOT REACH THE NAIL, SO THE SURGEON ADJUSTED THE OPERATION BY LIFTING THE INSERTION HANDLE A LITTLE AND PROCEEDED REAMING AGAIN. THE SURGEON SUCCEEDED IN REAMING,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15322695 ↗
• MalfunctionSep 2, 2021Device-Device Incompatibility; Device-Device Incompatibility

  THIS REPORT IS FOR ONE (1) AIM-ARM 125° F/STAT+DYN DIST LOCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12414566 ↗
• InjuryFeb 18, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT A SURGERY FOR THE FEMORAL TROCHANTERIC FRACTURE WITH THE AIMING ARMS (03.037.114, 03.037.113) AND THE FLEXIBLE SCREWDRIVER IN QUESTION. DURING THE SURGERY, THE SURGEON FELT DIFFICULTY USING THE AIMING ARMS BECAUSE THEY WERE TOO HEAVY. AND HE THOUGHT THAT ONLY THE PART OF THE FLEXIBLE DRIVER AROUND 20 MM FROM THE TIP NEEDED TO BE BENT. HE COULD NOT CONNECT THE DRIVER TO OTHER DEVICES WITHOUT MAKING MORE INCISION OF 10CM AND ADDUCTING THE AFFECTED LEG BECAUSE THE WHOLE SCREWDRIVER BENT. THE SURGERY COMPLETED WITHIN A THIRTY (30) MINUTE SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Tissue Damage

  MAUDE report 9720382 ↗
• MalfunctionJan 24, 2020Device-Device Incompatibility; Device-Device Incompatibility

  UPDATED EVENT DESCRIPTION: A 20 MINUTE SURGICAL DELAY OCCURRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9628594 ↗
• InjuryOct 18, 2018Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN SURGICAL PROCEDURE ON (B)(6) 2018, SURGEON WAS ATTEMPTING TO REMOVE AN UNKNOWN IMPLANT UTILIZING THE 2.4MM STARDRIVE SCREWDRIVER SHAFT WHEN THE SCREWDRIVER SHAFT BECAME DAMAGED AND FAILED TO REMOVE THE IMPLANT. SURGEON REPORTED THE REMOVAL WAS NOT SUCCESSFUL. CONCOMITANT DEVICE: SCREW (PART UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) 2.4MM STARDRIVE SCREWDRIVER SHAFT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7978926 ↗
• MalfunctionMay 16, 2017Failure To Adhere Or Bond; Failure To Adhere Or Bond

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED DURING A FEMORAL TROCHANTERIC FRACTURE PROCEDURE UTILIZING THE PROXIMAL FEMORAL NAILING SYSTEM (TFNA) ON (B)(6) 2017, SURGEON HAD DIFFICULTY INSERTING THE HELICAL BLADE. SURGEON CONTINUED THE INSERTION PROCESS AS IT WAS BELIEVED THE PATIENT BONE QUALITY WAS GOOD. IT WAS THEN NOTED THE 125 DEGREE AIMING ARM HAD BEEN CONNECTED TO THE NAIL INSTEAD OF THE 130 DEGREE AIMING ARM. SURGEON WAS UNABLE TO REMOVE THE HELICAL BLADE BECAUSE THE PROTECTION SLEEVE WAS TENSIONED, SO INSERTION OF THE BLADE CONTINUED. ONCE THE HELICAL BLADE WAS INSERTED, SURGEON WAS NOT ABLE TO REMOVE THE PROTECTION SLEEVE FROM THE AIMING ARM. THE AIMING ARM WAS THEN DETACHED FROM THE NAIL. AS A RESULT OF DETACHING THE AIMING ARM, SURGEON WAS THEN UNABLE TO REATTACH THE AIMING ARM TO THE ALREADY INSERTED NAIL. SURGEON THEN OPTED TO NOT IMPLANT THE SCREW. SURGERY WAS COMPLETED WITH A DELAY OF APPROXIMATELY 40 MINUTES. NO PATIENT HARM OR OTHER MEDICAL INTERVENTION WAS REPORTED. CONCOMITANT DEVICES REPORTED: HAMMER (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1), 130 DEGREE AIMING ARM (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN,

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6570604 ↗
• InjuryMay 10, 2017Fitting Problem; Failure to Align; Fitting Problem; Failure to Align

  SYNTHES (B)(4) REPORTED AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY TO TREAT FRACTURES PROXIMAL FEMUR AND FEMORAL SHAFT ON (B)(6) 2017, THE AIMING ARM AND GUIDE WIRE SLEEVE BECAME STUCK TOGETHER. THE SURGEON HAD FIRST INSERTED THE NAIL THEN THE GUIDE WIRE SLEEVE WAS INSERTED INTO THE AIMING ARM. IN ORDER TO ADJUST NAILING DEPTH, THE SURGEON TRIED TO REMOVE THE BUTTRESS COMPRESSION NUT FROM THE AIMING ARM. THIS IS WHEN THE AIMING ARM AND GUIDE WIRE SLEEVE ENGAGED AND BECAME STUCK. THIS ENGAGEMENT HAPPENED TO GENERATE A GAP BETWEEN THE GUIDE WIRE SLEEVE AND THE OUTER CORTICAL BONE. IN THIS UNSTABLE SURGICAL ATMOSPHERE, TAKING MEASUREMENTS OF THE BLADE LENGTH BECAME INACCURATE. THUS, THE SURGEON REPLACED TWO BLADES AND COMPLETED THE SURGERY WITH A 30 MINUTE DELAY. AFTER THE PROCEDURE, WHILE CLEANING THE ENGAGED AIMING ARM AND GUIDE WIRE SLEEVE, THE NURSE HAMMED THE STUCK SECTION AND WAS ABLE TO DETACH THE GUIDE WIRE SLEEVE. CONCOMITANT DEVICE: 1X UNK NAIL, 1X UNK COMPRESSION NUT, 1X UNK BLADE. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 6557001 ↗

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