NA 04.043.145SRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886982297655), received between Dec 14, 2022 and Dec 4, 2025 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (5 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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryDec 4, 2025Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT THE TIBIAL NAIL IMPLANT REMOVAL PROCEDURE DUE TO BREAKAGE. PER SURGEON THE BREAK WAS LIKELY DUE TO THE +3 MONTH NON-UNION OF A COMPLEX PROXIMAL TIBIAL FRACTURE. THE BROKEN NAIL WAS SUCCESSFULLY REMOVED AND A NEW TIBIAL NAIL WITH ADDITIONAL PLATING AND BONE GRAFT WAS INSERTED INTO THE PATIENT.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 23720711 ↗
• InjurySep 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2025 THAT, THE PATIENT UNDERWENT HARDWARE REMOVAL TNA. ALL AVAILABLE INFORMATION WAS DISCLOSED FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 23069376 ↗
• MalfunctionOct 30, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024 THE REAMING GUIDE ROD KEPT TRYING TO GO POSTERIOR TO THE PROXIMAL PEEK INLAY INSTEAD OF THROUGH THE CANNULATION. AFTER MULTIPLE ATTEMPTS TO GET THE REAMING ROD TO GO THROUGH, IT WAS DECIDED TO PULL THE NAIL OUT, REMOVE THE PEEK INLAY, AND RE-IMPLANT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THERE WAS 15 MINUTES OF SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20567052 ↗
• MalfunctionJun 6, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024 , WHILE IMPLANTING A TIBIAL NAIL ADVANCED 9 X 375MM THE 2.5MM REAMING ROD BECAME STUCK INSIDE THE NAIL WHEN TRYING TO REMOVE THE REAMING ROD. THE NAIL HAD TO BE REMOVED WITH THE REAMING ROD STILL STUCK IN IT. IT WAS REPLACED WITH A REAMING ROD AND NAIL OF THE SAME SIZES. PROLONGED ANESTHESIA, HIGHER AMOUNT OF X-RAYS, AND HIGHER SOFT TISSUE IRRITATION. THERE WAS A SURGICAL DELAY OF 35 MINUTES. THE PROCEDURE COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE (1) TIBIAL NAIL-ADVANCED / 9MM 375MM / STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19475655 ↗
• MalfunctionMay 1, 2024Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, PATIENT HAD A DISTAL TIBIA FRACTURE. AFTER REAMING TO APPROPRIATE DIAMETER, THE SURGEON INSERTED THE TIBIAL NAIL INTO THE CANAL. AFTER THE SURGEON INSERTED THE NAIL, HE DECIDED HE NEEDED TO REMOVE THE NAIL AND REAM AGAIN AFTER PLACING A BLOCKING WIRE. UPON REMOVING, IT WAS DISCOVERED THAT THE POLY INLAY FELL OUT OF THE DISTAL PORTION OF THE TIBIAL NAIL INTO THE PATIENT'S INTER MEDULLARY CANAL. THE DAMAGED POLY INLAY WAS REMOVED SUCCESSFULLY, AND WAS UNABLE TO BE RE-INSERTED INTO THE NAIL. A NEW NAIL OF THE SAME SIZE WAS OPENED, AND INSERTED INTO THE PATIENT. THERE WERE PATIENT STATUS/ OUTCOME / CONSEQUENCES REPORTED. THIS REPORT IS FOR ONE (1) TIBIAL NAIL-ADVANCED / 9MM 375MM / STERILE THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19226768 ↗
• MalfunctionSep 26, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023, DURING A TIBIAL NAIL CASE, THE SURGEON CHANGED TO A SMALLER SUPRAPATELLAR SLEEVE AS THEY WERE HAVING DIFFICULTY GETTING TO THE STARTING POINT. THE SURGEON WAS EVENTUALLY ABLE TO GET TO THE STARTING POINT AND PROCEEDED WITH THE SURGERY. WHEN PUTTING IN THE PROXIMALLY LOCKING SCREWS, THE DRILL BIT IN THE S1 SCREW HOLE HIT THE NAIL. THE SURGEON WAS UNABLE TO GET THE BIT PAST THE NAIL AND SO CHOSE OTHER SCREW HOLES WHERE THE SCREWS WERE SUCCESSFULLY INSERTED. THE SCREW HOLE ALIGNMENTS WERE CHECKED PRIOR TO NAIL INSERTION AND THEY ALL LINED UP, THE SURGEON FELT THAT THE AIMING ARM WAS NOT PROPERLY LATCHED. IT WAS DISCOVERED AT THE END OF THE SURGERY THAT THE SPRING ON THE LATCH OF THE AIMING ARM WAS NOT WORKING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE PATIENT OUTCOME. THERE WAS A SURGICAL DELAY OF 45 MINUTES. NO FRAGMENTS WERE GENERATED. NO ADDITIONAL INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A TIBIAL NAIL-ADVANCED / 9MM 375MM / STERILE. THIS IS REPORT 2 OF 3 FOR PC (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17819662 ↗
• MalfunctionDec 14, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2022 DURING A TRAUMA PROCEDURE, THE PEEK INLAY FROM THE TIBIAL NAIL ADVANCED CAME DISLODGED FROM AN UNUSED SCREW HOLE DURING NAIL INSERTION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THIS REPORT IS FOR A TIBIAL NAIL-ADVANCED / 9MM 375MM / STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15980435 ↗

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 A
• 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 A