NA 04.043.245SRecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10886982297808), received between Nov 9, 2021 and Sep 23, 2026 — classified as 1 injury, 18 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (10 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Device-Device Incompatibility

  It was reported that the top of the TFNA nail wouldn't mate with the TNA insertion handle. A new nail was opened and it worked fine. Cutout seemed to be holding on the first nail. There was no patient harm and no surgical delay is reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50869967 ↗
• MalfunctionAug 21, 2026Device-Device Incompatibility

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50380404 ↗
• MalfunctionJan 20, 2026Device-Device Incompatibility

  IT WAS REPORTED ON (B)(6) 2026, THAT TNA NAIL WOULDN'T ALLOW THE 2.5 MM BALL TIP GUIDE WIRE (STANDARD PART OF PROCEDURE) TO PASS. SEEMED TO BE ISSUES WITH POLY INLAY IN THE NAIL. SURGERY WAS DELAYED BY 1 HOUR DUE TO THE REPORTED EVENT. NEW NAIL WAS USED TO COMPLETE THE PROCEDURE. NO, PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24122141 ↗
• MalfunctionNov 12, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED DURING A TIBIAL NAIL SURGERY, NAIL INSERTION STEP, THE REGISTRAR SLID THE NAIL OVER THE SYNREAM WIRE TO PUSH THE NAIL DOWN THE TIBIAL CANAL, HOWEVER THE NAIL WAS PUSHED OVER THE SYNREAM WIRE AT AN ANGLE, THEREFORE, THE END OF THE SYNREAM WIRE CAUGHT ON THE LOCKING POLYMER THAT IS IN THE PROXIMAL END OF THE TIBIAL NAIL AND THE LOCKING POLYMER GOT DAMAGED. THE NAIL WAS REMOVED, AND A FRESH TIBAIL NAIL WAS OPENED AND INSERTED WITHOUT NO PROBLEMS; THIS TIME THE NAIL FOLLOWED THE SYNREAM WIRE TRAJECTORY WITHOUT ANGLING IT UPWARDS OR DOWNWARDS. THERE WAS NO ALLEGATION AGAINST THE SYNREAM WIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23536050 ↗
• MalfunctionSep 10, 2025Break; Break

  IT WAS REPORTED THAT WHEN INSERTING THE NAIL OVER A SMOOTH NON-SYNTHES GUIDE ROD, THE ROD GOT STOCK IN THE PROXIMAL PEEK INSERT AND DAMAGED THE PEEK. IT SEEMS TO HAVE SLID IN BEHIND THE PEEK MATERIAL AND DAMAGE THE AVAILABLE HOLE. STAFF HAD TO REMOVE THE NAIL AND OPEN A NEW NAIL. THE EVENT OCCURRED DURING A TIBIA FRACTURE PROCEDURE. NO FRAGMENTS WERE GENERATED. THERE WAS A DELAY OF 3 MINUTES AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT STATUS WAS REPORTED TO BE GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23017121 ↗
• MalfunctionJul 17, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A 2.5MM BALL TIP REAMING ROD WAS USED. THE SURGEON DID NOT OBSERVE THE POLY BEFORE IT WAS INSERTED OVER THE WIRE. THEN HE COULD NOT ADVANCE THE NAIL AND WHEN HE PULLED IT BACK THE DISTAL STATIC HOLE (IN THE PROXIMAL CLUSTER) WAS DEFORMED. THEY TRIED TO CUT IT OUT AND REINSERT BUT THAT DID NOT WORK. THEY GRABBED A NEW NAIL. EVERYTHING LOOKED GREAT AND WENT OVER THE SAME BALL TIP WITH NO TROUBLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22534972 ↗
• MalfunctionMay 20, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PEAK WAS INTERFERING WITH THE CANULATION AND THE SURGEON HAD TO USE A HEMOSTAT BECAUSE THE TIP OF THE NAIL WAS NOT ACCURATELY FUNCTIONING DURING THE PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 22055958 ↗
• MalfunctionOct 23, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, SUPPLIER HAS CONFIRMED THE PACKAGING ISSUE. THERE WAS A PURPLE TAG, INSTEAD OF THE USUAL BLUE TAG.

  Patient problems: Insufficient Information

  MAUDE report 20517046 ↗
• MalfunctionMar 22, 2024Device-Device Incompatibility; Appropriate Device Problem Term/Code Not Available; Device-Device Incompatibility; Appropriate Device Problem Term/Code Not Available

  DEVICE REPORT FROM THE UNITED KINGDOM REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024 DURING INSERTION OF THE NAIL, THE POLY INLAY BECAME STUCK. THE GUIDEWIRE IS IN, THE NAIL WAS INSERTED OVER THE GUIDEWIRE, AND AS THE PROXIMAL END OF THE GUIDEWIRE GETS TO THE HERZOG BEND IT WAS FORCED TO THE BACK OF THE CANNULATION IN THE NAIL. THE GUIDEWIRE GOES BETWEEN THE SLEEVE AND THE NAIL, BUT THE SLEEVE IS DEFORMED AND THE SURGEON CANNOT INSERT THE NAIL. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A TIBIAL NAIL-ADVANCED / 10MM 375MM / STERILE. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18958260 ↗
• MalfunctionAug 25, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT (B)(6) 2023 THE PEEK INLAY IN THE DISTAL END OF THE TIBIAL NAIL ADVANCED IMPLANT BECAME DISLODGED FROM THE NAIL AND PREVENTED REMOVAL OF THE REAMING ROD AFTER INSERTION OF THE NAIL. THE NAIL WAS REMOVED AND DISCOVERED TO BE DEFECTIVE. A DIFFERENT IMPLANT WAS USED TO COMPLETE THE CASE WITHOUT ISSUE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS REPORT IS FOR ONE (1) TIBIAL NAIL-ADVANCED / 10 375 / STERILE THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17624784 ↗
• MalfunctionAug 18, 2023Difficult to Advance; Material Integrity Problem; Difficult to Advance; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, THEY WERE INSERTING THE NAIL AND THE POLY INSIDE THE PROXIMAL PART OF THE NAIL SEEMED TO BE DAMAGED. THEY TRIED INSERTING THE BALL TIP WIRE THROUGH AND IT WOULD NOT ADVANCE. THEY REMOVED THE NAIL AND NOTICED THE POLY WAS DAMAGED. THERE WAS 3 MINUTE DELAY AND GOT A NEW NAIL OFF THE SHELF AND PLACED IT SUCCESSFULLY. NO FRAGMENTS GENERATED AND CASE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR ONE (1) TIBIAL NAIL-ADVANCED / 10 375 / STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17572350 ↗
• InjuryJul 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS FOR A POST MARKET STUDY AND CAPTURES THE RADIOLOGIC ASSESSMENTS AT 6 WEEKS AND 3 MONTHS POST-OP, WHICH SHOW THAT UNION HAS NOT BEEN ACHIEVED. THIS REPORT INVOLVES ONE (1) TIBIAL NAIL-ADVANCED / 10MM 375MM / STERILE. THIS IS REPORT 2 OF 10 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 17407690 ↗
• MalfunctionApr 21, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023 THE TIBIAL NAIL ADVANCED (TNA) FAILED TO PASS OVER 2.5 REAMING ROD DUE TO THE POLY INSERT OF THE PROXIMAL END OF THE NAIL. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH SURGICAL DELAY OF 4 MINUTES. NO PATIENT CONSEQUENCES WAS THERE.THIS REPORT IS FOR ONE (1) TIBIAL NAIL-ADVANCED / 10MM 375MM / STERILETHIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16788569 ↗
• MalfunctionJan 26, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SURGERY ON (B)(6) 2023, THE SURGEON WENT TO PUT IN A TNA, 10X 375, AND IT WASN¿T TO HIS PREFERENCE ONCE INSERTED. THE SURGEON WENT TO BACKSLAP IT OUT, AND THE POLYMER INSERTED FROM THE DISTAL TIP OF THE NAIL ALMOST CAME OUT. IT DELAYED SURGERY TO GRAB ANOTHER NAIL, WHICH WAS THEN INSERTED. THE PATIENT OUTCOME WASN¿T AFFECTED. THIS REPORT INVOLVES ONETIBIAL NAIL-ADVANCED/10MM 375MM/STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16247950 ↗
• MalfunctionDec 30, 2022Break; Break

  IT WAS REPORTED THAT DURING A TIBIAL NAIL PROCEDURE ON (B)(6) 2022, THE SURGEON ATTEMPTED TO PUT IN A SCREW AND BEGAN DRILLING WITH A 4.2 DRILL BIT. IT WAS LIGHTLY OFF AXIS, AND HE BEGAN TO TAP WITH A MALLET. HE THEN FINISHED OFF THE DRILLING TO THE FAR CORTEX. HE THEN ATTEMPTED TO USE X-RAY TO SEE THE POSITIONING, AND FOUND THAT THE DISTAL END OF THE NAIL WAS BROKEN. IT WAS A MORE DISTAL FRACTURE. THE BROKEN NAIL DID NOT DELAY THE SURGERY, BUT IT WAS OBVIOUSLY LESS IDEAL. THE SURGEON THEN PUT IN A SCREW AT THE A/P HOLE. IT WAS MORE DISTAL TO THE FRACTURE. THE NAIL REMAINED IN THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE TIBIAL NAIL-ADVANCED / 10MM 375MM / STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16078629 ↗
• MalfunctionSep 30, 2022Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT ON (B)(6) 2022 REAMING ROD LASER ETCH MARK WAS TOO LIGHT TO SEE DURING SURGERY. THAT RESULTED IN A MISMEASUREMENT OF THE NAILS. THERE WAS 30 MINS OF SURGICAL DELAY. THERE WAS NO PATIENT OUTCOME. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) TIBIAL NAIL-ADVANCED/10 375/STERILE. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15514320 ↗
• MalfunctionSep 8, 2022Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2022, DURING IMPLANTATION OF THE TIBIAL NAIL, THE 2.5MM LONG GUIDE ROD GOT STUCK ON THE DISTAL PORTION OF THE NAIL. NO BEND WAS PUT INTO THE GUIDE ROD BEFORE INSERTION. AFTER NUMEROUS ATTEMPTS, REMOVAL WAS UNSUCCESSFUL, SO THE SURGEON REMOVED THE ENTIRE NAIL. THERE WAS NO SURGICAL DELAY, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE PATIENT OUTCOME. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A TIBIAL NAIL-ADVANCED / 10MM 375MM / STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15378612 ↗
• MalfunctionJun 20, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2022, WHILE IMPLANTING A 10X375 SYNTHES TIBIAL ADVANCE NAIL, THE PIN THAT HELD THE SPRING IN PLACE ON THE IMPACTOR HANDLE HAD BROKEN. THIS ALLOWED FOR THE RELEASE MECHANISM TO MOVE FREELY ON THE IMPACTOR. THE SURGEON NOTED THAT THE AIMING ARM WAS MOVING INDEPENDENTLY OF THE NAIL, AND THEY ATTEMPTED TO RE-TIGHTEN THE CONNECTING SCREW, BUT IT WAS NOT LOOSE. UPON FURTHER INSPECTION OF THE NAIL/AIMING ARM ATTACHMENT POINT, IT LOOKED LIKE THE NAIL WAS BEGINNING TO SPLAY AT ITS PROXIMAL END. THE SURGEON WAS ABLE TO IMPACT THE REST OF THE NAIL UNTIL IT WAS FULLY INSERTED INTO THE PATIENT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY OTHER COMPLICATIONS. THIS REPORT IS FOR A TIBIAL NAIL-ADVANCED / 10MM 375MM / STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14747733 ↗
• MalfunctionNov 9, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING AN UNKNOWN PROCEDURE, THE BALL TIP GUIDEWIRE BECAME STUCK INSIDE THE TIBIAL NAIL ADVENCED (TNA) AND WAS UNABLE TO BE REMOVED. THE WIRE WAS INCARCERATED IN THE TIP OF THE NAIL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A TWENTY (20) MINUTE SURGICAL DELAY. PATIENT STATUS IS UNKNOWN.THIS REPORT IS FOR ONE (1) UNK - NAILS: TIBIAL. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12779624 ↗

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