NA 03.043.021Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10886982297204), received between Sep 21, 2021 and Apr 24, 2026 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (16 reports).

2 other recalls cover devices cleared under the same FDA submission (K201336); 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 24, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT INSERT-HANDLE RADIOLUC MED AND UNK - NAILS WERE INVOLVED IN AN INTRAOPERATIVE EVENT. THE REPORTED FAILURE WAS THE INABILITY TO PROPERLY CONNECT THE NAIL TO THE AIMING ARM, REQUIRING A SECOND SET TO BE OPENED AND RESULTING IN A FIVE-MINUTE SURGICAL DELAY. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT, AND NO SIGNS, SYMPTOMS, OR PATIENT INVOLVEMENT WERE OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24984132 ↗
• MalfunctionMar 30, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT INSERTION HANDLE/ RADIOLUCENT MEDIUM AND AIM-ARM RADIOLUC WERE INVOLVED IN AN EVENT DURING A PARAPATELLAR TIBIA NAIL INSERTION PROCEDURE. WHILE PLACING PROXIMAL INTERLOCKING SCREWS USING THE AIMING ARM, THE DRILL BIT STRUCK THE NAIL, RESULTING IN A SLIGHT PROCEDURAL DELAY OF 3-5 MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WAS NO REPORTED PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24726980 ↗
• MalfunctionFeb 19, 2026Device-Device Incompatibility; Material Deformation

  THE TNA TARGETING JIG BENT INTRAOPERATIVELY AND COULD NO LONGER BE CONNECTED TO THE NAIL. THE SECOND INSTRUMENT SET HAD TO BE OPENED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A TEN-MINUTE DELAY. THERE WERE NO FRAGMENTS. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24393758 ↗
• MalfunctionFeb 18, 2026Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2026, THE PATIENT UNDERWENT AN UNKNOWN SURGERY. DURING SURGERY, THE SURGEON TRIED TO REMOVE THE INSERTION HANDLE, BUT IT WAS TOO STIFF TO TURN, SO HE CHECKED THE IMAGE OF THE CONNECTING PART, AND IT LOOKED DEFORMED. THE SURGEON REMOVED ONE OF THE LOCKING SCREWS, INSERTED METAL INTO THAT HOLE AND SET IT COUNTER-CLOCKWISE. AFTER APPLYING VIBRATION TO THE HANDLE, THE SURGEON WAS ABLE TO TURN AND REMOVE IT. THE REMOVED SCREW WAS REINSERTED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24380933 ↗
• MalfunctionOct 30, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A PROCEDURE ON AN UNKNOWN DATE, SEVERAL TIBIAL NAIL PRODUCTS HAD BEEN EXPERIENCING ONGOING ISSUES, SPECIFICALLY, THE INFRA, PARA, AND SUPRAPATELLAR HANDLES, AS WELL AS ALL ASSOCIATED JIGS AND CONNECTING SCREWS. THE JIG AND INSERTION DID NOT MATCH UP WITH THE NAIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23427432 ↗
• MalfunctionOct 30, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A PROCEDURE ON AN UNKNOWN DATE, SEVERAL TIBIAL NAIL PRODUCTS HAD BEEN EXPERIENCING ONGOING ISSUES, SPECIFICALLY, THE INFRA, PARA, AND SUPRAPATELLAR HANDLES, AS WELL AS ALL ASSOCIATED JIGS AND CONNECTING SCREWS. THE JIG AND INSERTION DID NOT MATCH UP WITH THE NAIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23427416 ↗
• MalfunctionOct 30, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A PROCEDURE ON AN UNKNOWN DATE, SEVERAL TIBIAL NAIL PRODUCTS HAD BEEN EXPERIENCING ONGOING ISSUES, SPECIFICALLY, THE INFRA, PARA, AND SUPRAPATELLAR HANDLES, AS WELL AS ALL ASSOCIATED JIGS AND CONNECTING SCREWS. THE JIG AND INSERTION DID NOT MATCH UP WITH THE NAIL. THE SOFT TISSUE SLEEVE WAS DEFORMED. LOT NUMBERS ON CONNECTING SCREWS ARE WORN OFF AND NOT LEGIBLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23425544 ↗
• MalfunctionAug 1, 2025Break; No Apparent Adverse Event; Break; No Apparent Adverse Event

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PIN THAT IS IN THE HEAD OF THE DRIVING CAP POPPED OUT RENDERING THE ENTIRE INSTRUMENT UNUSABLE. THERE WAS NO PATIENT CONSEQUENCE REPORTED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22686503 ↗
• MalfunctionMay 27, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, WHILE DOING A TIBIA NAIL, THE AIMING ARM GOT STUCK ON THE INSERTION HANDLE. THE SURGEON WANTED TO REMOVE THE AIMING ARM TO INSERT THE NAIL FURTHER BECAUSE THE 4.2 DRILL BIT WAS MISSING THE NAIL WHILE DRILLING THE PROXIMAL STATIC AND DYNAMIC HOLE. HE WAS UNABLE TO REMOVE THE AIMING ARM FROM THE INSERTION HANDLE AFTER TRYING MANY TIMES. SURGEON TAPPED ON THE DRIVING CAP TO INSERT THE NAIL FURTHER. THE AIMING ARM WHERE IT ATTACHES TO THE INSERTION HANDLE BROKE AND TWO CARBON FIBER PIECES FELL OFF THE FIELD. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22086729 ↗
• MalfunctionMay 8, 2025Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2025 THE INSTRUMENT WERE BROKEN. THE PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 21985035 ↗
• MalfunctionFeb 13, 2025Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT: A. WHAT APPROACH WAS USED FOR THE TIBIAL NAIL PROCEDURE (SUPRAPATELLAR, INFRAPATELLAR?) INFRAPATELLAR. B. PLEASE CONFIRM WHICH HOLE WAS BEING TARGETED WHEN THE PROBLEM OF HITTING THE NAIL OCCURRED (PROXIMAL STATIC 1, PROXIMAL STATIC 2, DYNAMIC, PROXIMAL OBLIQUE 1, PROXIMAL OBLIQUE 2). PROXIMAL STATIC 1, DYNAMIC. C. IT WAS REPORTED THAT THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PLEASE EXPLAIN WHAT STEPS WERE TAKEN IN ORDER TO ACHIEVE A SUCCESSFUL OUTCOME. PROXIMAL OBLIQUE HOLES AND FREE HAND LOCKING. D. WHAT WAS THE ANGLE OF KNEE FLEXION, AND DID IT CHANGE DURING SURGERY? FLEXION 45 10, YES. E. WAS THE COMPRESSION SCREW USED? NO F. WAS THE NAIL OVER INSERTED? IF YES, HOW FAR? NO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21373333 ↗
• MalfunctionSep 11, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT AN ORIF WITH TNA FOR THE TIBIAL DIAPHYSEAL FRACTURE. THIS CASE WAS DEPLOYED WITH A LATERAL PARAPATELLAR APPROACH. AFTER CHECKING OUTSIDE OF THE BODY, THE NAIL WAS INSERTED WITH HAMMERING. WHEN DRILLING TO INSERT A SCREW INTO THE PROXIMAL STATIC ML HOLE, THE DRILL BIT INTERFERED WITH THE NAIL. THE SURGEON DECIDED THAT SLIGHT ADJUSTMENT WAS NECESSARY, AND DRILLED TO THE PROXIMAL DYNAMIC ML HOLE. HOWEVER, THE DRILL BIT INTERFERED WITH THE NAIL AGAIN. SINCE THE AIMING ARM WAS NOT WORKING PROPERLY, DRILLING WAS PROCEEDED MANUALLY, AND THE SCREW WAS INSERTED. WHEN THE CONNECTING SCREW WAS REMOVED, THERE WAS A STRANGE SOUND. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE INSERT-HANDLE RADIOLUC MED. THIS IS REPORT 2 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20188961 ↗
• MalfunctionNov 30, 2023Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT ON NOVEMBER 8, 2023, THE STAINLESS STEEL NECK OF THE HANDLE THAT FITS INTO THE NAIL HAD BEEN BENT AND DAMAGED AND WOULD NOT SECURELY HOLD THE NAIL. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH A THREE-MINUTE DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE INSERTION HANDLE/ RADIOLUCENT MEDIUM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18236800 ↗
• MalfunctionJun 8, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT THE OPEN REDUCTION INTERNAL FIXATION WITH THE TIBIAL NAIL ADVANCED (TNA) FOR THE TRANSVERSE FRACTURE OF THE DIAPHYSEAL TIBIA. THE PATIENT HAD GOOD BONE QUALITY. THE SURGEON PLACED THE KNEE IN MILD FLEXION TO AVOID THE RISK OF INTERFERENCE BETWEEN THE NAIL AND THE LOCKING SCREW. WHEN THE SURGEON DETERMINED THE ENTRY POINT OF THE NAIL, HE COULD NOT INSERT THE GUIDE WIRE BECAUSE THE INSERTION ANGLE OF THE GUIDE WIRE WAS 15 TO 20 DEGREES INSTEAD OF THE IDEAL ANGLE 10 DEGREES. AFTER REAMING THE MEDULLARY CANAL, THE SURGEON INSERTED THE NAIL WITH THE HAMMER. THE NAIL MAY HAVE BEEN DEFORMED DUE TO LOAD ON THE NAIL WHILE INSERTING THE NAIL WITH THE HAMMER BECAUSE THE SHAPE OF THE NAIL AND THE SHAPE OF THE BONE IN THE OPEN WOUND WERE DIFFERENT. THE LOCKING SCREW INTERFERED WITH THE NAIL HOLE WHILE INSERTING THE DISTAL LOCKING SCREW. THE SURGEON TIGHTENED THE LOCK ON THE INSERTION HANDLE FIRMLY AGAIN. THE SURGEON COULD INSERT THE LOCKING SCREW IN THE PROXIMAL NAIL HOLE (CENTRAL HOLE) WITHOUT INTERFERENCE. THE SURGEON TRIED TO INSERT THE DISTAL LOCKING SCREW INTO T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14629788 ↗
• MalfunctionMay 12, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: THIS IS REPORT 4 OF 4 FOR PC- (B)(4). IT WAS REPORTED BY THE SALES REP IN JAPAN THAT DURING AN OPEN REDUCTION INTERNAL FIXATION WITH THE TNA FOR THE DIAPHYSEAL FRACTURE OF THE RIGHT TIBIA ON (B)(6) 2022 USING A LATERAL PARAPATELLAR APPROACH, THE SURGEON OBSERVED THAT THE DRILL BIT HIT AND INTERFERED WITH THE NAIL HOLE DURING DRILLING FOR THE DISTAL ML HOLE. ACCORDING TO THE REPORT, THE DRILL BIT WAS SLIGHTLY THROUGH THE HOLE, SO THAT THE SURGEON SLIGHTLY HIT THE DRILL BIT WITH A NYLON HAMMER. IT WAS REPORTED THAT AFTER PASSING THE DRILL BIT THROUGH THE NAIL HOLE, THE SURGEON DRILLED THE CONTRALATERAL CORTEX WITH POWER TOOLS AND INSERTED A SCREW. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. IT WAS FURTHER REPORTED THAT THE SURGEON BELIEVED THAT THERE WERE THREE POSSIBLE CAUSES AS FOLLOWS: THE KNEE FLEXION POSITION MAY HAVE BEEN INSUFFICIENT FOR THE PATIENT¿S FEMORAL CONDYLE.INSUFFICIENT KNEE FLEXION MAY HAVE CAUSED THAT THE ENTRY POINT WAS POSTERIOR, AND THE NAIL WAS INSERTED WHILE INTERFERING WITH THE POSTERIOR CORTEX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14379343 ↗
• MalfunctionApr 14, 2022Device-Device Incompatibility; Device-Device Incompatibility

  THIS IS REPORT 1 OF 3 FOR (B)(4). IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE WHEN THE DOCTOR WAS DRILLING THE PROXIMAL MEDIAL TO MAKE A LATERAL STATIC HOLE IN AN ANS TIBIA NAIL, HE NOTICED THAT THE DRILL BIT WAS MAKING CONTACT WITH THE IMPLANT. IT WAS FURTHER REPORTED THAT THE DRIVING CAP WAS ALSO STUCK IN THE NAIL INSERTION HANDLE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) INSERTION HANDLE/ RADIOLUCENT MEDIUM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14115642 ↗
• MalfunctionSep 22, 2021Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT, THE PATIENT UNDERWENT A PROCEDURE DURING WHICH THE AIMING ARM HOOKS TO BOTH AND SNAPPED OFF. THE DRILL BIT WAS HITTING THE NAIL THROUGH THE TRIPLE SLEEVES. OUT OF THE 3 CASES PERFORMED WITH THE TNA, 2 OF 3 CASES HIT THE NAIL WITH SEMI-EXTENDED PARA PATELLAR APPROACH. PROCEDURE WAS COMPLETED SUCCESSFULLY. CONCOMITANT DEVICES REPORTED: UNKNOWN TRIPLE SLEEVES (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN). THIS REPORT IS FOR ONE (1) INSERTION HANDLE/ RADIOLUCENT MEDIUM. THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12514476 ↗
• MalfunctionSep 21, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON UNKNOWN DATE, PATIENT UNDERWENT FOR A PROCEDURE. DURING THE PROCEDURE, THE AIMING ARM "HOOKS" BOTH SNAPPED OFF, AND THE DRILL BIT WAS HITTING THE NAIL THROUGH THE TRIPLE SLEEVES. IT IS UNKNOWN IF THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS IS UNKNOWN. THIS COMPLAINT INVOLVES FIVE (5) DEVICES. THIS REPORT IS FOR (1) INSERTION HANDLE/ RADIOLUCENT MEDIUM. THIS REPORT IS 1 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12508994 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K201336. One submission often covers many models, so check the product and lot details in each record.

• Z-0229-2026 · Sep 26, 2025 · Open, Classified
  LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 42MM / XL25/ STER. Product Code: 04.045.342TS. Used in RFN-ADVANCEDTM Retrograde Femoral Nailing (RFNA) System and the Tibial Nail Adva
• Z-0228-2026 · Sep 26, 2025 · Open, Classified
  LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 46MM / XL25/ STER. Product Code: 04.045.346TS. Used in RFN-ADVANCEDTM Retrograde Femoral Nailing (RFNA) System and the Tibial Nail Adva