NA 04.043.120SRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10886982297600), received between Jan 17, 2024 and May 30, 2025 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 30, 2025Use of Device Problem; Detachment of Device or Device Component; Use of Device Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT AN OSTEOSYNTHESIS FOR THE FRACTURE ON TIBIA WITH THE NAIL IN QUESTION. IN THE SURGERY, THE NAIL WAS STERILE, UNPACKED, AND INSERTED INTO THE BODY. THE NAIL WAS REMOVED BECAUSE THE INSERTION POSITION WITHIN THE MEDULLARY CAVITY WAS INSUFFICIENT, AND THE POLYMER INLAY IN THE DISTAL HOLE OF THE NAIL WAS FOUND TO BE PROTRUDING FROM THE NAIL. THE SURGEON STOPPED USING THE PRODUCT BECAUSE THERE WAS A POSSIBILITY THAT THE FIXATION FORCE WOULD BE AFFECTED, AND SELECTED AND INSERTED A NAIL OF A DIFFERENT SPECIFICATION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22116431 ↗
• MalfunctionMay 2, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A FEMORAL RECON NAIL CASE, THE INFERIOR LOCKING HOLE DID NOT INITIALLY ALIGN WITH THE ARMING ARM. THE WIRE WAS AIMING ANTERIOR TO THE LOCKING HOLE. THE SURGEON WAS ABLE TO INSERT A GUIDE WIRE THROUGH THE SUPERIOR LOCKING HOLE AND CORRECTED THE ALIGNMENT. AFTER A FEW ATTEMPTS, THE WIRE EVENTUALLY PASSED THROUGH THE INFERIOR LOCKING HOLE. WHEN DISTAL LOCKING THE NAIL, THE SHORT RETENTION PIN TIP BROKE OFF INSIDE THE PATIENT AND WAS STILL ATTACHED TO THE SCREW. ONCE THERE FRAGMENT WAS REMOVED THE SURGERY WAS SUCCESSFULLY COMPLETED. THERE WAS A SURGICAL DELAY OF 70 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21952056 ↗
• MalfunctionApr 17, 2025Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING A CASE THE SURGEON BACKSLAPPED OUT A TNA ONCE AND WHEN THE NAIL CAME OUT, THE DISTAL INLAY WAS PARTIALLY OUT OF THE NAIL AND BROKEN IN HALF. THE DISTAL PORTION OF INLAY BROKE WHEN THE SURGEON BACKSLAPPED THE NAIL.

  Patient problems: Insufficient Information

  MAUDE report 21853857 ↗
• MalfunctionMar 28, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A TIBIAL NAIL WAS DISASSEMBLED OUT OF THE PACKAGING. THE ISSUE WAS NOTED INTRAOPERATIVELY. THERE WERE NO ISSUES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21722096 ↗
• InjuryFeb 24, 2025Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2025, THE SURGEON RETURNED FOR AN IM NAIL REMOVAL AFTER DISCOVERING OF A NONUNION. UPON REMOVAL OF THE NAIL IT WAS DISCOVERED THAT A MECHANICAL FAILURE HAD OCCURRED. THE NAIL FAILED AT THE DISTAL LOCKING HOLE AND A NEW IM NAIL WAS INSERTED. THERE WAS NONUNION AND A REVISION OF BROKEN TIBIA. THERE WAS PATIENT CONSEQUENCES.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 21445894 ↗
• MalfunctionSep 4, 2024Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, IN A RECENT TIBIAL NAIL FRACTURE CASE, THE SURGEON EXPERIENCED SOME CHALLENGES WITH THE TNA NAIL. AFTER THE REAMING ROD WAS FULLY INSERTED, THE SURGEON NEEDED TO RE-SEAT THE NAIL. THE DISTAL PORTION OF THE PEEK INLAY IN THE NAIL ENDED UP COMING INTO CONTACT WITH THE REAMING ROD, AND SPLITTING INTO PIECES. THEY REMOVED THAT FIRST TNA NAIL, AND INSERTED A SECOND, NEW TNA NAIL. THE REAMING ROD WAS FULLY INSERTED AT THIS POINT. THEY WERE ABLE TO INSERT THE NAIL OVER THE DISTAL PORTION OF THE PEEK INLAY, BUT ONCE THEY HAD INSERTED IT TO THE POINT WHERE THE REAMING ROD WAS COMING INTO CONTACT WITH THE PROXIMAL PORTION, THE ROD WAS ¿STUCK¿ ON THE INLAY (MEANING THEY COULD NOT GET THE REAMING ROD CENTERED WITHIN THE ID OF THE PEEK INLAY). THEY WERE ABLE TO USE A HEMOSTAT THROUGH THE INSTRUMENTED END OF THE TNA NAIL TO ¿CENTER¿ THE REAMING ROD AND EVENTUALLY GET THE NAIL FULLY INSERTED. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT INVOLVES ONE TIBIAL NAIL-ADVANCED / 9MM 300MM / STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20135057 ↗
• MalfunctionSep 4, 2024Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, IN A RECENT TIBIAL NAIL FRACTURE CASE, THE SURGEON EXPERIENCED SOME CHALLENGES WITH THE TNA NAIL. AFTER THE REAMING ROD WAS FULLY INSERTED, THE SURGEON NEEDED TO RE-SEAT THE NAIL. THE DISTAL PORTION OF THE PEEK INLAY IN THE NAIL ENDED UP COMING INTO CONTACT WITH THE REAMING ROD, AND SPLITTING INTO PIECES. THEY REMOVED THAT FIRST TNA NAIL, AND INSERTED A SECOND, NEW TNA NAIL. THE REAMING ROD WAS FULLY INSERTED AT THIS POINT. THEY WERE ABLE TO INSERT THE NAIL OVER THE DISTAL PORTION OF THE PEEK INLAY, BUT ONCE THEY HAD INSERTED IT TO THE POINT WHERE THE REAMING ROD WAS COMING INTO CONTACT WITH THE PROXIMAL PORTION, THE ROD WAS ¿STUCK¿ ON THE INLAY (MEANING THEY COULD NOT GET THE REAMING ROD CENTERED WITHIN THE ID OF THE PEEK INLAY). THEY WERE ABLE TO USE A HEMOSTAT THROUGH THE INSTRUMENTED END OF THE TNA NAIL TO ¿CENTER¿ THE REAMING ROD AND EVENTUALLY GET THE NAIL FULLY INSERTED. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT INVOLVES ONE TIBIAL NAIL-ADVANCED / 9MM 300MM / STERILE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20135052 ↗
• MalfunctionFeb 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THERE WAS A 10-MINUTE DELAY IN THE SURGERY. THE PATIENT OUTCOME WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18711156 ↗
• MalfunctionJan 17, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023, DURING INTRAOPERATIVE PLACEMENT OF A TIBIAL NAIL, THE TNA WAS INSERTED, BUT THE SURGEON WANTED TO SINK THE NAIL FURTHER. SURGEON REMOVED THE NAIL SO THAT HE COULD REAM THE CANAL DEEPER. UPON TRYING TO REAM THE CANAL FURTHER, SURGEON WAS UNABLE TO SECONDARY TO DISLODGED PEEK INLAY FROM THE TIBIAL NAIL. THIS RENDERED THE NAIL USELESS. THE SURGEON THEN HAD TO USE A NAIL THAT WAS ONE SIZE LONGER SECONDARY TO THIS ISSUE. SALES REP HAD TO GET ANOTHER LONGER NAIL TO USE WHICH CAUSED SURGICAL DELAY. THE CASE WAS ABLE TO BE SUCCESSFULLY COMPLETED. THE FRAGMENTS FROM THE POLY INLAY WERE REMOVED. THIS REPORT IS FOR ONE (1) TIBIAL NAIL-ADVANCED / 9MM 300MM / STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18529398 ↗

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