NA 04.043.335SRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886982298232), received between Apr 6, 2022 and Mar 11, 2026 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 11, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PEEK INLAY OF THE TIBIAL NAIL ADVANCED (TNA) CAME OUT OF THE NAIL DISTALLY WHEN BACKSLAPPING THE NAIL OUT OF THE CANAL. THIS RESULTED IN A SURGERY DELAY OF 20 MINUTES, AS THE SURGEON HAD TO CUT OFF THE INLAY TO REMOVE IT INSTEAD OF REMOVING THE BALL TIP ROD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24571328 ↗
• MalfunctionMar 24, 2023Break; Break

  THIS REPORT IS AGAINST USER FACILITY MEDWATCH NUMBER MW5115253. A COPY IS ATTACHED. THE ONLY INFORMATION CONTAINED IN THIS REPORT IS CORRECTION OR ADDITIONAL INFORMATION. IT WAS REPORTED THAT THERE WAS NO SURGICAL DELAY IN RELATION TO THE EVENT. A NEW NAIL WAS IMPLANTED DURING THE SURGICAL TIME, AND THERE WERE NO ISSUES NOTED POST-OPERATIVELY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16611978 ↗
• InjuryMar 20, 2023Use of Device Problem; Use of Device Problem

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE 34-YEAR-OLD MALE PATIENT UNDERWENT THE UNKNOWN SURGERY FOR TIBIA WITH TNA. THIS IS A REPORT OF A NAIL TOP PROTRUSION THAT RESULTED IN THE REMOVAL SURGERY TO REPLACE IT. ALTHOUGH THERE WAS SOME HESITATION IN NAIL SIZING DUE TO THE DEEP DISTAL NATURE OF THE CASE, THE NAIL IN QUESTION WAS FIXED WITH THE NAIL TOP PROTRUDING APPROXIMATELY 5 MM. THE NAIL WAS INSERTED JUST TO THE DISTAL TIBIAL ARTICULAR SURFACE, AND THE SURGEON DETERMINED THAT FURTHER INSERTION WOULD BE DIFFICULT, SO THE WOUND WAS CLOSED IN ANTICIPATION OF EARLY REMOVAL. THE NAIL REPLACEMENT WAS SCHEDULED TO BE PERFORMED ON (B)(6) 2023. ACCORDING TO THE SURGEON, THE DECISION TO REPLACE THE NAIL WAS BASED ON CONCERNS ABOUT KNEE CONTRACTURE. THIS REPORT IS FOR A TIBIAL NAIL-ADVANCED / 11MM 345MM / STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Joint Contracture

  MAUDE report 16574090 ↗
• MalfunctionFeb 14, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023, A 11X345MM TNA WAS INSERTED OVER A BALL TIPPED REAMING ROD. THE SURGEON ATTEMPTED TO REMOVE THE GUIDE ROD AND THE BALL TIP GOT STUCK JUST INSIDE THE DISTAL TIP OF THE NAIL. AFTER MULTIPLE ATTEMPTS, THE NAIL AND GUIDE ROD WERE REMOVED. UPON INITIAL INSPECTION, THE DISTAL PEEK SLEEVE APPEARS TO HAVE BEEN PULLED PROXIMAL INTO THE NAIL BY THE BALL TIP, THE SLEEVE WAS TWISTED AND BLOCKING THE HOLES IN THE NAIL, AND THE MOST DISTAL PIECE OF THE SLEEVE APPEARED TO BE BROKEN OFF. AFTER SEVERAL ATTEMPTS TO REMOVE THE BALL TIPPED GUIDE ROD, A SECOND NAIL WAS OPENED AND INSERTED. ORIGINAL 11X345MM TNA WAS REMOVED AND STUCK ON THE 351.706S GUIDE WIRE. A 10X345MM TNA WAS IMPLANTED SUCCESSFULLY. THERE WAS A SURGICAL DELAY OF 30 MINUTES. THERE WAS NO PATIENT CONSEQUENCES. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) TIBIAL NAIL-ADVANCED/11 345/STERILE. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16375843 ↗
• InjuryJan 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT SURGERY FOR HARDWARE REMOVAL AND REVISION NAILING DUE TO NON-UNION OF THE TIBIA. THE DATE OF ORIGINAL IMPLANT IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE TIBIAL NAIL-ADVANCED / 11MM 345MM / STERILE. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 16224119 ↗
• MalfunctionJan 9, 2023Device-Device Incompatibility; Device-Device Incompatibility

  THE SURGERY TIME WAS EXTENDED BY TWO HOURS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY PROBLEMS WITH IMPLANT FIXATION DUE TO THE USE OF AN ALTERNATIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16124315 ↗
• MalfunctionJul 18, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON UNKNOWN DATE THAT, THE PATIENT HAD AN EXISTING 4.5MM LCP PROXIMAL TIBIA PLATE. THE INTENT WAS TO TENSION THE LATERAL SIDE TO REDUCE THE MALUNION/NON UNION THEN NAIL THE TIBIA AND AUGMENT THE MEDIAL SIDE WITH A BUTTRESS PLATE. UPON PLACEMENT OF THE ATD ON THE EXISTING LATER PLATE, THE HOOK FROM THE ATD SWIVEL BROKE OFF. WE RETRIEVED THE ITEM FROM THE PATIENT, NO RESIDUAL FRAGMENTS WERE LEFT IN THE PATIENTS. WE USED A NEW ATD AND IT WORKED FINE. WHEN NAILING THE TIBIA THE POLY INSIDE THE TNA NAIL BECAME DAMAGED WHEN TRYING TO REMOVE THE GOLD "TEAR DROP" ZIMMER GUIDE ROD (47-2490-097-00) AFTER INSERTION OF THE NAIL. WE REALIZED IT WHEN WE WERE ROTATING THE TNA SUPRAPATELLAR HANDLE ATTACHED TO THE NAIL BUT THE HOLES IN THE NAIL ON X RAY WERE NOT MOVING. SO WE REMOVED THE NAIL AND HAD TO REAM UP AND USE THE NEXT SIZE DIAMETER NAIL. WE ONLY HAD ONE EACH OF THE TNA SIZES. THERE WERE A SURGICAL DELAY OF 20 MINUTES. PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME IS STABLE. THIS REPORT IS FOR A TIBIAL NAIL-ADVANCED / 11MM 345MM / STERILE. THIS IS REPORT 1 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15042829 ↗
• MalfunctionApr 6, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE USA AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2022, THAT THE INSERT CAME OUT OF THE END OF THE TIBIAL NAIL ADVANCE. THE NAIL WAS IMPLANTED AND REMOVED SEVERAL TIMES PRIOR TO THIS HAPPENING. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS COMPLAINT INVOLVES ONE (1) DEVICE TIBIAL NAIL-ADVANCED / 11 345 / STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14022300 ↗

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