NA 04.043.230SRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10886982297778), received between May 24, 2022 and Jun 17, 2025 — classified as 6 injuries, 7 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. 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT AN UNKNOWN SURGERY FOR TIBIA SHAFT FRACTURE WITH THE NAIL. THE DISTAL TNA NAIL, POLYMER INLAY DISPLACEMENT, AND PROTRUSION FROM THE NAIL TIP WAS CONFIRMED DURING THE SURGERY. THE SURGEON PROCEEDED WITH THE SURGERY AS PER THE PROCEDURE MANUAL. THE NAIL WAS INSERTED USING A REAMING ROD FROM A KIT. THE INCIDENT OCCURRED WHEN THE NAIL WAS TEMPORARILY REMOVED TO CORRECT IT TO THE INDICATED POSITION. AN ATTEMPT WAS MADE TO REPAIR THE DISPLACED POLYMER INLAY, BUT IT WAS NOT POSSIBLE TO RECOVER THE POLYMER INLAY AND GAVE UP USING IT. A DIFFERENT SIZE NAIL WAS SELECTED AND OPENED, AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30MINS OF DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22236023 ↗
• InjuryFeb 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED POSTOPERATIVE NONUNION AFTER TREATMENT WITH THE TIBIAL NAIL ADVANCED FOR A RIGHT TIBIAL FRACTURE. THE DEVICES HAD BEEN IMPLANTED ON (B)(6) 2023. ON (B)(6) 2023, THE PATIENT UNDERWENT A REMOVAL OF HARDWARE, BONE GRAFTING, AND PLACEMENT OF A NEW INTRAMEDULLARY NAIL. THIS REPORT INVOLVES ONE TIBIAL NAIL-ADVANCED / 10MM 330MM / STERILE. THIS IS REPORT 1 OF 6 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 18623438 ↗
• MalfunctionDec 27, 2023Break; Migration; Break; Migration

  IT WAS REPORTED THAT ON (B)(6) 2023, WHEN THE ADVANCED TIBIAL NAIL WAS INSERTED INTO A NON-UNION TIBIA, THE SURGEON DECIDED TO REAM A HALF SIZE LARGER, SO THEY PROCEEDED TO TAKE THE TIBIAL NAIL OUT. ONCE THE TIBIAL NAIL CAME OUT, THEY NOTICED THE DISTAL PEEK INSERT HAD MIGRATED OUTSIDE THE DISTAL END, AND FRAGMENTS FROM THE PEEK WERE VISIBLE UPON INSPECTION. THEY DID NOT HAVE AN ADDITIONAL NAIL OF THAT SIZE AND LENGTH, SO THEY IMPLANTED A NAIL 1 MM GREATER THAN WAS INTENDED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF 20 MINUTES. THE SURGEON HAD TO DRILL 1MM GREATER TO ACCOMMODATE THE LARGER NAIL. THE PEEK POLY APPEARED TO BE ALL CONTAINED, HOWEVER THE PEEK WAS FRACTURED AND IN PIECES WHEN REMOVED. IT IS UNKNOWN IF ANY FRAGMENTS WERE RETAINED IN THE PATIENT. THIS REPORT INVOLVES ONE TIBIAL NAIL-ADVANCED / 10MM 330MM / STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18401427 ↗
• MalfunctionSep 27, 2023Use of Device Problem; Difficult to Advance; Use of Device Problem; Difficult to Advance

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2023, IT WAS NOT POSSIBLE TO FULLY INSERT A TIBIAL NAIL. A NEW TIBIAL NAIL, A DIAMETER SIZE DOWN, WAS RETRIEVED AND USED INSTEAD. SURGERY WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR A TIBIAL NAIL-ADVANCED / 10MM 330MM / STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17828808 ↗
• InjurySep 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2023 DURING POST-OP THE HARDWARE REMOVAL FROM THE TIBIA NAIL DUE TO INFECTION. (04.043.230S) X1 TIBIA NAIL ADVANCD 10X330MM, LOT #3323P28. THE PATIENT EXPERIENCED AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING. PATIENT CONSEQUENCE WAS INFECTION AND REVISION. THIS REPORT IS FOR ONE (1) TIBIAL NAIL-ADVANCED / 10 330 / STERILE. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 17802612 ↗
• InjuryJun 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY ID: (B)(6). SUBJECT ID: (B)(6). ADVERSE EVENT TERM: NONUNION. IS THIS A WORSENING OF AN EXISTING EVENT? NO. SITE AWARENESS DATE: 05-06-2023. TYPE OF EVENT: LOCAL/FRACTURE SITE. SIDE: LEFT. IS THE ADVERSE EVENT SERIOUS? YES. SEVERITY: MODERATE. THIS REPORT IS FOR A TIBIAL NAIL-ADVANCED / 10MM 330MM / STERILE. THIS IS REPORT 2 OF 10 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 17212962 ↗
• InjuryJun 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY ID: DEPUY - DST202103 SUBJECT ID: (B)(6). ADVERSE EVENT TERM: HETEROTOPIC OSSIFICATION OF LEFT TIBIA. DEVICE: TNA. SEVERITY: MODERATE. TYPE OF EVENT: LOCAL/FRACTURE SITE. IS THIS A WORSENING OF AN EXISTING EVENT? NO. OUTCOME: RECOVERED/RESOLVED. THIS REPORT IS FOR A TIBIAL NAIL-ADVANCED / 10MM 330MM / STERILE. THIS IS REPORT 2 OF 12 FOR (B)(4).

  Patient problems: Extraskeletal ossification

  MAUDE report 17154036 ↗
• InjuryNov 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A POSTOPERATIVE ADVERSE EVENT OF NONUNION OCCURRED AFTER TREATMENT OF TIBIAL NAIL FRACTURE WITH THE IMPLANTS IN QUESTION. THE DEVICES WERE IMPLANTED ON (B)(6) 2021, AND EXPLANTED ON (B)(6) 2022. THE REMOVAL SURGERY WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE TIBIAL NAIL-ADVANCED / 10MM 330MM / STERILE. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 15753145 ↗
• InjuryOct 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A FRACTURE-RELATED INFECTION OCCURRED AFTER IMPLANTING THE PRODUCT. THE ORIGINAL IMPLANTATION SURGERY OCCURRED ON (B)(6) 2021. THIS REPORT INVOLVES ONE TIBIAL NAIL-ADVANCED / 10MM 330MM / STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 15549710 ↗
• MalfunctionSep 30, 2022Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT ON (B)(6) 2022 REAMING ROD LASER ETCH MARK WAS TOO LIGHT TO SEE DURING SURGERY. THAT RESULTED IN A MISMEASUREMENT OF THE NAILS. THERE WAS 30 MINS OF SURGICAL DELAY. THERE WAS NO PATIENT OUTCOME. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) TIBIAL NAIL-ADVANCED / 10 330 / STERILE THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15514225 ↗
• MalfunctionAug 8, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022 DURING AN ORIF SURGERY FOR DISTAL SHAFT FRACTURE OF TIBIA, THE DRILL INTERFERED WITH THE NAIL IN QUESTION IN A PROXIMAL ML STATIC HOLE. A SCREW WAS INSERTED SUCCESSFULLY BY HAMMERING ADJUSTMENT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF UNDER 30 MINUTES. ACCORDING TO THE SALES REP WHO WAS PRESENT, THE INTERFERENCE MAY BE DUE TO DISTORTION OF THE INSERTION HANDLE AND NAIL CONNECTION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A TIBIAL NAIL-ADVANCED / 10MM 330MM / STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15182413 ↗
• MalfunctionJun 6, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2022, THE TIBIAL NAIL INNER POLY LINING STRIPPING FROM PROXIMAL OBLONG SCREW HOLE, PRE INSERTION. STRIPPED POLY WAS NOTICED UPON REMOVAL FROM COMPANY PACKAGING. CONCOMITANT PRODUCT REPORTED: UNK - SCREWS: NAIL PROXIMAL LOCKING (QUANTITY# 1). THIS REPORT IS FOR ONE (1) TIBIAL NAIL-ADVANCED/10 330/STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14603183 ↗
• MalfunctionMay 24, 2022Device-Device Incompatibility; Device-Device Incompatibility

  WHILE REMOVING THE NAIL TO PLACE A BLOCKING SCREW DURING SURGERY ON (B)(6) 2022 THE POLY WITHIN THE NAIL CAME OUT OF THE END, AND THE PROXIMAL POLY ROTATED. NO FRAGMENTS WERE GENERATED. THERE WERE 5 MINUTES OF SURGICAL DELAY. SURGERY WAS SUCCESSFULLY COMPLETED. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14491954 ↗

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