NA 04.043.435SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982298089), received between Jul 18, 2022 and Aug 15, 2023 — classified as 1 injury, 3 malfunctions.

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

• MalfunctionAug 15, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023, THE PIN HAD FALLEN OUT OF THE TNA DRIVING CAP. DURING THE PROCEDURE, A TNA NAIL WAS INSERTED, BUT THEN REMOVED TO DIAL IN THE REDUCTION. WHEN THE NAIL WAS EXTRACTED, IT WAS NOTICED THAT THE POLY INSERTED DISTALLY HAD MOVED OUTSIDE OF THE NAIL, THE SURGICAL TECH WAS NOT ABLE TO PUT BACK INTO THE NAIL, AND A NEW NAIL WAS SELECTED. THIS NAIL WAS ALSO EXTRACTED FOR REPOSITIONING AND THE SLEEVE HAD MOVED AS WELL, BUT SURGEON DECIDED TO MOVE FORWARD AND DRILL THROUGH THE POLY INSERT. ADDITIONALLY, THE SURGEON WAS HAVING ISSUES INSERTING THE NAIL THROUGH THE SUPRAPATELLAR PROTECTION SLEEVE, SO IT WAS REMOVED AND THE NAIL WAS INSERTED WITHOUT THE SLEEVE. DURING THE SURGERY, THE SURGEON USED A DRILL BIT IN A ¿BLOCKING¿ FASHION TO REDIRECT THE NAIL, BUT THE DRILL BIT WAS UNABLE TO REMAIN STABLE BECAUSE OF THE COMMINUTION. THEN A BLOCKING SCREW WAS USED. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A TIBIAL NAIL-ADVANCED / 12MM 345MM / STERILE. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17548591 ↗
• MalfunctionAug 15, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023, THE PIN HAD FALLEN OUT OF THE TNA DRIVING CAP. DURING THE PROCEDURE, A TNA NAIL WAS INSERTED, BUT THEN REMOVED TO DIAL IN THE REDUCTION. WHEN THE NAIL WAS EXTRACTED, IT WAS NOTICED THAT THE POLY INSERTED DISTALLY HAD MOVED OUTSIDE OF THE NAIL, THE SURGICAL TECH WAS NOT ABLE TO PUT BACK INTO THE NAIL, AND A NEW NAIL WAS SELECTED. THIS NAIL WAS ALSO EXTRACTED FOR REPOSITIONING AND THE SLEEVE HAD MOVED AS WELL, BUT SURGEON DECIDED TO MOVE FORWARD AND DRILL THROUGH THE POLY INSERT. ADDITIONALLY, THE SURGEON WAS HAVING ISSUES INSERTING THE NAIL THROUGH THE SUPRAPATELLAR PROTECTION SLEEVE, SO IT WAS REMOVED AND THE NAIL WAS INSERTED WITHOUT THE SLEEVE. DURING THE SURGERY, THE SURGEON USED A DRILL BIT IN A ¿BLOCKING¿ FASHION TO REDIRECT THE NAIL, BUT THE DRILL BIT WAS UNABLE TO REMAIN STABLE BECAUSE OF THE COMMINUTION. THEN A BLOCKING SCREW WAS USED. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A TIBIAL NAIL-ADVANCED / 12MM 345MM / STERILE. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17548589 ↗
• InjuryJul 19, 2022Break; Break

  IT WAS REPORTED ON (B)(6) 2022 THAT A PATIENT WAS INVOLVED, ONE OF THE TIBIAL NAIL TNA, THE DISTAL POLYMER INLAY CAME OUT INSIDE THE PATIENT. THEY WERE ABLE TO RETRIEVED THE INLAY. THIS REPORT IS FOR ONE (1) TIBIAL NAIL-ADVANCED / 12 345 / STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 15056181 ↗
• 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 / 12MM 345MM / STERILE. THIS IS REPORT 2 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15042727 ↗

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