NA 04.043.150SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982297662), received between Jan 27, 2022 and Jul 23, 2024 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 23, 2024Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2024, THE POLY INLAY IN THE TIBIAL NAIL WAS DISLODGED AND CAUSED A BLOCKAGE WITHIN THE NAIL. THIS MADE IT UNABLE TO PASS THE BALL TO GUIDE WIRE DOWN THE CANNULATION OF THE NAIL. SURGERY WAS SUCCESSFUL COMPLETED WITH NO DELAY. THIS REPORT IS FOR A TIBIAL NAIL-ADVANCED / 9MM 390MM / STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19806528 ↗
• InjuryMay 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT (B)(6). AE1: POSTOPERATIVE ADVERSE EVENT: " NONUNION". IS THE AE RELATED TO THE TREATMENT OF FRACTURE? "YES".. IS THE AE RELATED TO THE DEVICE? "YES". DPS IMPLANT WAS USED. PATIENT UNDERWENT REVISION SURGERY. PATIENT IS RECOVERING. THIS REPORT IS FOR A TIBIAL NAIL-ADVANCED / 9MM 390MM / STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 19253886 ↗
• InjurySep 29, 2022Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT REVISION SURGERY FOR A BROKEN TIBIAL NAIL THAT HAD BEEN IMPLANTED THREE MONTHS PRIOR. THE PATIENT HAD HYPERTROPHIC NONUNION, AND THE NAIL WAS BROKEN THROUGH THE DISTAL/PROXIMAL SCREW HOLE OF THE ANS TIBIAL NAIL 9-390MM. THE SURGEON REMOVED ALL THE SCREWS INTACT AND UTILIZED AN EXTRACTION HOOK TO REMOVE THE ENTIRE NAIL INCLUDING THE DISTAL PORTION BELOW THE NAIL BREAKAGE. IT WAS A DIFFICULT PROCEDURE. THE NAIL WAS REPLACED WITH A TIBIAL NAIL EX10X390MM WITH MULTIPLE SCREWS AND BLOCKING SCREWS. IT WAS REPORTED THAT THE PATIENT WEIGHED 300 POUNDS AND HAD MULTIPLE COMORBIDITIES. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE TIBIAL NAIL-ADVANCED / 9MM 390MM / STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 15501499 ↗
• MalfunctionJan 27, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021 DURING A TIBIA PROCEDURE, THE SURGEON IMPLANTED THE TIBIAL NAIL IN QUESTION. THE NAIL WAS INSERTED PER NORMAL TECHNIQUE AND WAS THEN SUBSEQUENTLY REMOVED TO PERFORM ADDITIONAL INTRAMEDULLARY REAMING. UPON REMOVAL, WE NOTICED THE DISTAL POLY INLAY HAD PARTIALLY POPPED OUT OF THE END OF THE NAIL. THE SURGEON WAS ABLE TO PUSH IT BACK IN MANUALLY AND RE-INSERT THE NAIL AND COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS AN UNSPECIFIC AMOUNT OF SURGICAL DELAY. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) TIBIAL NAIL-ADVANCED / 9MM 390MM / STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13366780 ↗

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