NA 04.043.130SRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886982297624), received between Apr 21, 2022 and Jul 23, 2025 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionJul 23, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A NAIL REMOVAL. THE PEEK SLEEVE DETACHED FROM THE DISTAL SCREW CLUSTER, WHICH WAS NEVER FOUND. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22579323 ↗
• InjurySep 20, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024 THE PROXIMAL TIBIA NAIL WAS BROKEN IN PROXIMAL STATIC INTERLOCK. THERE WERE NO FRAGMENTS GENERATED. THE BROKEN NAIL WAS REMOVED AND REPLACED WITH A 10MM NAIL. IT OCCURRED AFTER THE ORIGINAL SURGERY WHICH WAS ON (B)(6) 2024.

  Patient problems: Insufficient Information

  MAUDE report 20273558 ↗
• MalfunctionSep 3, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6) 2024 THE DISTAL POLY CAME OUT OF TIBIAL NAIL ADVANCED (TNA) WHEN BACKSLAPPING NAIL OUT. IT STAYED IN NAIL BUT WAS OUT BY ABOUT 15MM. SURGEON NO LONGER WANTED TO USE SAME NAIL AS THE TIP OF THE POLY HAD BEEN COMPROMISED. THERE WAS NO PATIENT CONSEQUENCES.THIS REPORT IS FOR ONE (1) TIBIAL NAIL-ADVANCED / 9MM 330MM / STERILE.THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20130394 ↗
• MalfunctionApr 7, 2023Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT ON (B)(6)2023, DURING THE INSERTION OF TIBIAL NAIL ADVANCED(TNA) THE SURGEON NOTICED RESISTANCE AROUND THE AREA OF THE FRACTURE. SURGEON PULLED THE NAIL OUT AND PROCEEDED TO CLEAN OUT THAT AREA PULLING OUT A SMALL PIECE OF BONE. SURGEON THEN REINSERTED THE NAIL AND AGAIN NOTICE RESISTANCE. SURGEON PULLED OUT THE NAIL AGAIN AND FOUND THE POLY SLEEVE FROM OUR NAIL IN THE CANAL WHICH WOULD NOT ALLOW THE NAIL TO BE INSERTED FULLY. SURGEON THEN DISCARDED THAT NAIL AND FORTUNATELY HAD ANOTHER NAIL OF THE SAME SIZE AND WAS THEN ABLE TO FULLY INSERT THE NAIL AND PROCEEDED WITH THE REST OF THE CASE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A TWENTY(20) MINUTES OF SURGICAL DELAY. NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) TIBIAL NAIL-ADVANCED / 9MM 330MM / STERILE THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16702720 ↗
• InjuryJan 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE AE HAS BEEN REPORTED FOR SUBJECT 00073-013 FOR THE DST202103 STUDY: SUBJECT ID: 00073-013. ADVERSE EVENT: NONUNION. SITE AWARENESS DATE: (B)(6) 2022. START DATE: (B)(6) 2022. SERIOUS: NO. RELATIONSHIP TO STUDY DEVICE: POSSIBLE. RELATIONSHIP TO STUDY PROCEDURE: CAUSAL RELATIONSHIP. THIS REPORT IS FOR A TIBIAL NAIL-ADVANCED / 9MM 330MM / STERILE. THIS IS REPORT 1 OF 5 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 16243379 ↗
• MalfunctionNov 21, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TIBIAL NAIL ADVANCED WAS USED DURING INTRA OP. BACK SLAP WAS CROSS THREADED INTO HAMMER GUIDE DUE TO OFF AXIS AND MALLET WAS UNABLE TO BE TAKEN OFF. THREADED PORTION OF CONNECTING ELEMENTS WERE STRIPPED. MULTIPLE WIRE GUIDE WAS BENT WITH WIRE. BENDERS WERE USED TO BEND BACK GUIDE BUT DID NOT WORK. TORQUE LIMITERS INTRA OP DID NOT WORK WITH A QC STRYKER DRILL. NO SURGICAL DELAY WAS REPORTED. NO ADDITIONAL INFORMATION WAS REPORTED. THIS REPORT IS FOR A TIBIAL NAIL-ADVANCED / 9MM 330MM / STERILE. THIS IS REPORT 3 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15833886 ↗
• MalfunctionMay 10, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE USA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022 THE SURGEON WAS DOING AN INTERMEDULLARY TIBIAL NAIL USING THE TIBIA NAIL ADVANCE SYSTEM. DURING THE PROCEDURE PLACED ONE MEDIAL TO LATERAL 5.0 LOCKING SCREW IN THE DISTAL STATIC HOLE. WHILE DRILLING WITH THE 5.0MM DRILL BIT THROUGH AN APPROPRIATELY PLACED TROCAR, AND WAS HITTING THE NAIL WITH THE DRILL BIT. HE TOGGLED THE DRILL BIT AROUND IN A CIRCULAR MOTION AND WAS ABLE TO GET THE DRILL BIT TO PASS THROUGH THE NAIL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCES. THIS COMPLAIN INVOLVES ONE DEVICE TIBIAL NAIL-ADVANCED / 9 330 / STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14347764 ↗
• MalfunctionApr 21, 2022Device-Device Incompatibility; Device-Device Incompatibility

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE TIBIAL NAIL DEVICE DID NOT MATCH UP WITH AN UNKNOWN PROXIMAL LOCKING SCREW DEVICE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT FOR 1 (ONE) TIBIAL NAIL-ADVANCED / 9 330 / STERILE DEVICE. THIS COMPLAINT INVOLVES TWO (2) DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14166953 ↗

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