NA 04.043.250SRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886982297815), received between Mar 20, 2022 and Nov 13, 2025 — classified as 2 injuries, 5 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. 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.

• MalfunctionNov 13, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SURGEON WAS ATTEMPTING TO PUT A TNA OVER THE BALL TIPPED GUIDEWIRE, BUT THE NAIL WOULD NOT FULLY PASS OVER THE WIRE TO GO INTO THE PATIENT. THE BALL TIPPED WIRE WAS CATCHING ON THE POLYMER PEEK INLAY JUST PROXIMAL TO THE PROXIMAL BEND IN THE NAIL. WE TRIED ROTATING THE HANDLE 180 DEGREES, BUT IT WOULD NOT GO THROUGH AS THE POLYMER WAS MOVING AND TRANSLATING UP. ALTHOUGH THE POLYMER IS OPTIONAL AND MAY BE REMOVED IF NOT DESIRED BY THE SURGEON, IF NOT REMOVED IT SHOULD STILL PASS OVER THE WIRE WHEN USING. SURGEON STRUGGLED AND THEN DECIDED TO OPEN A NEW NAIL GOING FROM 10X390MM TO A 10X375MM NAIL. THE NAIL WAS TESTED WITH A NEW BALL TIPPED WIRE THE NEXT DAY AND WAS HAVING THE SAME RESULT OF THE NAIL NOT BEING ABLE TO PASS OVER THE NAIL. THERE WAS ABOUT A 5-MINUTE DELAY IN THE SURGERY. SURGERY WAS COMPLETED SUCCESSFULLY, AND ALL PIECES WERE ACCOUNTED FOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23543373 ↗
• InjuryApr 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT THE INITIAL PROCEDURE ON (B)(6) 2022, WITH TIBIAL ADVANCED NAIL AND SCREWS TO TREAT RIGHT TIBIAL SHAFT FRACTURE. SIX MONTHS POSTOP PATIENT HAD NONUNION. THIS REPORT IS FOR ONE (1) TIBIAL NAIL-ADVANCED / 10MM 390MM / STERILE. THIS IS REPORT 1 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 19028830 ↗
• MalfunctionFeb 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2023, THE POLY IN A TIBIAL NAIL ADVANCED (TNA) NAIL CAME OUT WHILE INSERTING THE NAIL. PROCEDURE WAS COMPLETED WITH A TEN TO FIFTEEN MINUTE DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A TIBIAL NAIL-ADVANCED / 10MM 390MM / STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18711888 ↗
• InjurySep 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  POSTOPERATIVE ADVERSE EVENT: "FRACTURE-RELATED INFECTION (FRI)". IS THE AE RELATED TO THE TIBIAL FRACTURE AND/OR TREATMENT OF TIBIAL FRACTURE? "YES". IS THE AE RELATED TO THE DEVICE? "POSSIBLE". DPS IMPLANT WAS USED. THIS REPORT IS FOR A TIBIAL NAIL-ADVANCED / 10MM 390MM / STERILE. THIS IS REPORT 1 OF 6 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture; Unspecified Infection

  MAUDE report 17817202 ↗
• MalfunctionOct 4, 2022Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED THAT ON (B)(6) 2022 PATIENT UNDERWENT IM INTRAMEDULLARY NAILING. WHEN THE NAIL WAS INSERTED FULLY, THE NAIL WAS LOCKED PROXIMALLY. DURING DRILLING STATIC 1, IT HIT THE NAIL. PERFECT CIRCLES PROXIMALLY TO COMPENSATE FOR THE DRILL MISSING THE NAIL WAS DONE. WHILE TIGHTENING SCREW: SCREW DRIVER HEAD WAS WARPED FROM OVER TORQUEING. A SECOND SET WAS OPEN AND THE SECOND SCREWDRIVER WAS WARPED AS WELL. THERE WAS 5 MINUTES SURGICAL DELAY. THERE WAS NO PATIENT STATUS, OUTCOME AND CONSEQUENCES. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR ONE (1) TIBIAL NAIL-ADVANCED / 10 390 / STERILE. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15540629 ↗
• MalfunctionSep 6, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2022 AT THE TIME OF USING A TIBIAL NAIL AND ONE OF THE LOCKING SCREWS MISSED THE NAIL THROUGH AIMING JIG. THERE WAS SURGICAL DELAY DUE TO THE REPORTED EVENT BUT THE SURGERY WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS NORMAL. THIS REPORT IS FOR ONE (1)TIBIAL NAIL-ADVANCED / 10 390 / STERILE. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15361182 ↗
• MalfunctionMar 20, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2022, WHILE INSERTING A TIBIAL NAIL, THE REAMING ROD BECAME LODGE IN THE END OF THE NAIL. THE TIBIAL NAIL WAS EXTRACTED, AND THE BALL TIP OF THE REAMING ROD WAS CUT AND REMOVED FROM THE NAIL. THE NAIL WAS REINSERTED. ADDITIONALLY, A DRILL BIT THAT HAS BEEN USED TO CHANGE THE DIRECTION OF THE NAIL WAS BROKEN WHEN REMOVAL WAS ATTEMPTED. A BONE FRAGMENT OR PART OF THE SLEEVE WAS LODGE IN THE NAIL INHIBITING THE BALL TIP FROM THE REAMING ROD TO BE REMOVED. THE FRAGMENT WAS ABLE TO BE ABLE REMOVED. THERE WAS A TEN (10) MINUTE SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR A TIBIAL NAIL. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13834847 ↗

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 A
• 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