NA 04.043.225SRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10886982297761), received between Nov 4, 2022 and Feb 17, 2026 — classified as 4 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 17, 2026Detachment of Device or Device Component

  IT WAS REPORTED ON (B)(6) 2026, THAT THE NAIL WAS INSERTED AND THEN PULLED BACK OUT IN ORDER TO REDUCE THE FRACTURE BEFORE CONTINUING. WHEN NAIL WAS PULLED OUT, THE DISTAL PEEK INSERT WAS HALFWAY OUT OF THE NAIL. THE SURGEON PULLED THE REMAINING PORTION FULLY OUT OF THE NAIL DUE TO IT COMING OUT ALREADY. PEEK INSERT WAS ATTEMPTED TO BE RE-INSERTED INTO THE NAIL BUT WAS UNSUCCESSFUL. SURGEON DECIDED A NEW NAIL WAS NEEDED. NO PATIENT INVOLVEMENT AND NO DELAY. ITEM IS NOT AVAILABLE FOR RETURN. NO DELAY IN SURGERY DUE TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24365254 ↗
• MalfunctionDec 22, 2025Break; Crack; Device-Device Incompatibility; Break; Crack; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT SURGERY WITH TNA FOR TIBIAL SHAFT FRACTURES. THE SURGEON USED A REAMING ROD BY SLIGHTLY BENDING IT, THEN PERFORMED REAMING, AND INSERTED THE NAIL. FOLLOWING THE NAIL INSERTION, THE SURGEON REMOVED THE NAIL TO REINSERT THE BLOCKER PIN, BUT THE NAIL BECAME STUCK WITH THE REAMING ROD. THE NAIL WAS REMOVED SUCCESSFULLY BY BACKSLIDING, BUT THE DISTAL INLAY OF THE NAIL CRACKED AND BROKE. THE SURGEON REINSERTED ANOTHER NAIL WITH A DIFFERENT LENGTH. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 30 MINUTES OF DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23864448 ↗
• MalfunctionAug 29, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6) 2024 THE TNA NAIL BROKE AT THE HEAD OF THE NAIL WHILE INSERTING INTO THE PATIENT TIBIA. THE PEEK AT THE DISTAL PART OF THE NAIL CAME OUT AS WELL WHEN PULLING OUT. THERE WAS NO PATIENT CONSEQUENCES. THERE WAS A SURGICAL DELAY OF A FEW MINUTES. THERE WERE NO FRAGMENTS RETAINED IN THE PATIENT. THIS REPORT INVOLVES ONE (1) TIBIAL NAIL-ADVANCED / 10MM 315MM / STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20095413 ↗
• InjuryFeb 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS TREATED FOR A LEFT SIDE CLOSED SHAFT FRACTURE WITH A TNA (TIBIAL NAIL ADVANCED) ON (B)(6) 2023. FOUR LOW-PROFILE LOCKING SCREWS WERE USED FOR FIXATION. ON (B)(6) 2023, THE PATIENT EXPERIENCED SEPSIS, WHICH REQUIRED HOSPITALIZATION. THE OUTCOME WAS RECOVERED/RESOLVED AFTER TREATMENT WITH INJECTED MEDICATION AND ORAL/TOPICAL MEDICATION. THIS REPORT INVOLVES ONE TIBIAL NAIL-ADVANCED / 10MM 315MM / STERILE. THIS IS REPORT 1 OF 5 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture; Pain; Sepsis

  MAUDE report 18713889 ↗
• MalfunctionJan 24, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2024 THE SURGEON WAS INSERTING A TIBIAL NAIL. UPON AN X-RAY IMAGE HE WAS UNHAPPY WITH HIS REDUCTION AND BACKSLAPPED THE NAIL OUT IN ORDER TO REVISE HIS REDUCTION. UPON REMOVAL OF THE NAIL IT WAS REALIZED THAT THE PEEK INLAY IN THE DISTAL PORTION OF THE NAIL WAS DISORIENTED. AFTER ATTEMPTING TO REORIENT THE INLAY IT WAS DISCOVERED THAT THE A PORTION OF THE PEEK BROKE OFF AND WAS NEVER LOCATED. THE PEEK IN THE DISTAL PART OF THE NAIL WAS REMOVED BEFORE REINSERTION. THE PEEK WAS REMOVED IN THE DISTAL PORTION. THE MISSING PEEK WAS NEVER LOCATED. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY AND NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) TIBIAL NAIL-ADVANCED / 10 315 / STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18571190 ↗
• InjuryJan 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE PATIENT WITH A TNA EXPERIENCED POSTOP HYPERTROPHIC NON-UNION. THIS REPORT INVOLVES ONE (1) TIBIAL NAIL-ADVANCED / 10MM 315MM / STERILE. THIS IS REPORT 1 OF 7 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture; Pain

  MAUDE report 18467171 ↗
• InjuryNov 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT HAD A NONUNION POST-TIBIAL NAILING. THE NAIL WAS REMOVED ON (B)(6) 2023. THE PATIENT HAD ADVERSE EVENTS SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING, OR OOZING. THIS REPORT IS FOR ONE (1) TIBIAL NAIL-ADVANCED / 10 315 / STERILE. THIS IS REPORT 1 OF 7 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 18142772 ↗
• MalfunctionAug 3, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2023, ONE OF THE NAILS WAS DEFORMED DURING IMPLANTATION ON THE PROXIMAL DRIVING END. ANOTHER NAIL WAS ALSO DEFORMED AT THE DISTAL TIP DURING IMPLANTATION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH THE ONLY DELAY BEING THE TIME NEEDED TO SWITCH OUT THE NAILS. THE PATIENT OUTCOME WAS REPORTED TO BE FINE. THIS REPORT INVOLVES ONE TIBIAL NAIL-ADVANCED / 10MM 315MM / STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17449979 ↗
• MalfunctionAug 3, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2023, ONE OF THE NAILS WAS DEFORMED DURING IMPLANTATION ON THE PROXIMAL DRIVING END. ANOTHER NAIL WAS ALSO DEFORMED AT THE DISTAL TIP DURING IMPLANTATION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH THE ONLY DELAY BEING THE TIME NEEDED TO SWITCH OUT THE NAILS. THE PATIENT OUTCOME WAS REPORTED TO BE FINE. THIS REPORT INVOLVES ONE TIBIAL NAIL-ADVANCED / 10MM 315MM / STERILE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17449978 ↗
• MalfunctionMay 23, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023 THE CONNECTING SCREW WOULD NOT COME DISENGAGED FROM THE TIBIAL NAIL IMPLANT. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A TEN(10) MINUTES OF SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS REPORT IS FOR ONE (1) TIBIAL NAIL-ADVANCED / 10MM 315MM / STERILE. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16982689 ↗
• InjuryNov 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE SITE NAV (NASHVILLE, US) REPORTED AN ADVERSE EVENT IN OUR DATABASE WHICH IS CONSIDERED (POSSIBLY) RELATED TO THE DEVICE. SUBJECT NAV-203. POSTOPERATIVE ADVERSE EVENT: "OTHER AE RELATED TO THE PROCEDURE OR IMPLANT: COMPARTMENT SYNDROME". IS THE AE RELATED TO THE TIBIAL FRACTURE AND/OR TREATMENT OF TIBIAL FRACTURE? YES. IS THE AE RELATED TO THE DEVICE? YES. DPS IMPLANT WAS USED. THIS REPORT IS FOR ONE (1) TIBIAL NAIL-ADVANCED / 10 315 / STERILE. THIS IS REPORT 1 OF 8 FOR COMPLAINT: (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15725291 ↗

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-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
• 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