NA 04.043.240SRecalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10886982297792), received between Jun 9, 2022 and Sep 29, 2026 — classified as 6 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (8 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Material Twisted/Bent

  It was reported during the operation, while inserting the TNA nail, it was observed that the proximal nail tip was damaged. Due to the condition of the nail, surgeon rejected the nail due to patient safety concerns. No patient harm. No surgical delay. Procedure was completed successfully through use of a new nail.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50930288 ↗
• MalfunctionJun 29, 2026Difficult to Advance

  IT WAS REPORTED THAT THE TIBIAL NAIL WAS MEASURED ON TWO OCCASIONS: FIRST BY THE RESIDENT AND THEN BY THE INSTITUTIONAL DOCTOR, USING CALIBRATED RULE AND SYREAM MILLING GUIDE, DIAMETER 2.5 MM AND LENGTH 9.50 MM, REFERENCE 352.032. FOR A TOTAL LENGTH OF 370 MM IT WAS DETERMINED TO USE A NAIL OF 360 MM. AFTER IMPLANTATION IT WAS VERIFIED THAT THE NAIL PROTRUDED 3 CM. GIVEN THIS, IT WAS DECIDED TO USE A 330 MM NAIL. THE SURGEON CLAIMS THAT THE GUIDE WAS UNCALIBRATED, SO THE SYSTEM WAS CHECKED ON THE SURGICAL TABLE. WE PROCEEDED TO CHANGE THE NAIL FOR ONE OF 330 MM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25650069 ↗
• MalfunctionApr 1, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE REAMING ROD MAY HAVE CAUSED THE INLAY TO BUCKLE UP WHICH PREVENTED IT ADVANCING THROUGH THE NAIL. THE NAIL WAS THE TRIED TO PASS OVER THE REAMING ROD A FEW TIMES, IT DIDN¿T PASS. THEY TRIED TO STRAIGHTEN THE POLY OUT BUT WERE NOT ABLE. EVENTUALLY THE PASSED THE NAIL WITHOUT THE REAMING ROD AND PROCEEDED WITH THE CASE. IT ADDED ABOUT 10 MINUTES TO THE PROCEDURE. THE OUTCOME WAS STILL GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24754058 ↗
• MalfunctionNov 21, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, UNABLE TO TIBIAL NAIL ADVANCED 10 X 360 NAIL OVER REAMING ROD 351.708S. REAMING ROD GOT STUCK. THEY REMOVED NAIL AND REAMING ROD. PUT BOTH INTO TIBIA TOGETHER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH 10MINS OF SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23619815 ↗
• InjuryNov 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO NON-UNION AND MAL-UNION.

  Patient problems: Malunion of Bone; Nonunion/Delayed-union Bone Fracture

  MAUDE report 23619791 ↗
• MalfunctionNov 5, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED ON (B)(6) 2025, DURING A PROCEDURE WHEN THE TIBIAL NAIL WAS INSERTED INTO THE PATIENT INTRAMEDULLARY CANAL, THE PEEK INLAY IN THE DISTAL INTERLOCKING PORTION OF THE NAIL BECAME DISLODGED AND PROTRUDED FROM THE DISTAL END. THE INLAY WAS UNABLE TO BE REINSERTED AND ULTIMATELY THE NAIL HAD TO BE REMOVED AND ANOTHER NAIL HAD TO BE USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23477426 ↗
• MalfunctionMay 14, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6)2025, WHERE THE INSERTION HANDLE AND THE NAIL CONNECT SEEMED TO HAVE GOTTEN TWISTED OR MISALIGNED SOMEHOW. AFTER NAIL INSERTION THE HANDLE AND THE NAIL WERE NOT MOVING AS A UNIT. NAIL WAS EXTRACTED AND A NEW NAIL AND INSERTION HANDLE WAS USED TO COMPLETE THE CASE. IT HAPPENED DURING SUPRA PATELLAR TIBIAL NAILING. THERE WAS A SURGICAL DELAY OF 3-4 MINS. CASE WAS SUCCESSFULLY COMPLETED AND THERE WAS NO PATIENT STATUS/ OUTCOME / CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22020843 ↗
• MalfunctionJan 24, 2025Break; Break

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE PATIENT ENDED UP WITH A NEW NAIL OF THE SAME SIZE AS THE ONE THAT HAD THE BROKEN INLAY. THE NAILING PROCEDURE WENT WELL ONCE WE GOT A REPLACEMENT NAIL. NO NOTABLE FRAGMENTS WERE GENERATED. DUE TO THE INLAY BEING PULLED OUT AND BROKEN DURING INSERTION THE NAIL WOULD NOT PROGRESS DOWN THE CANAL EASILY AND WE COULDN'T GET DISTAL INTERLOCKING SCREWS IN, SO WE TOOK MORE X RAYS THAN EXPECTED AND HAD TO DO A NAIL REMOVAL BEFORE GETTING A REPLACEMENT OF THE SAME SIZE. BEYOND THAT NO FURTHER INTERVENTION WAS REQUIRED. THE ONLY PATIENT INVOLVEMENT WAS A SLIGHTLY LONGER PROCEDURE DUE TO HAVING TO REMOVE A NAIL AND THEN GET A REPLACEMENT. THERE WASN'T ANY SIGNIFICANT NOTABLE PATIENT CONSEQUENCE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21232420 ↗
• MalfunctionSep 18, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A CASE, THE PEEK INLAY IN THE DISTAL PORTION OF THE NAIL CAME OUT. THE CASE WAS AN OPEN TIBIAL FRACTURE, WHICH ALLOWED THE DIRECT VISIBILITY. THIS OCCURRED WHEN THE SURGEON HAD BACKED UP THE NAIL, AND THE REAMING ROD WAS ALREADY INSERTED. THE SURGEON REMOVED THE PEEK INLAY AND PROCEEDED WITH THE NAIL CASE, JUST WITHOUT THE INLAY DISTALLY. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20246035 ↗
• MalfunctionJun 13, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, PEEK INSERT IN DISTAL PORTION OF THE NAIL DISENGAGED FROM NAIL UPON REMOVAL. THERE WAS A 2 MINUTE SURGICAL DELAY. A SECOND NAIL WAS OPENED AND USED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCES. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT INVOLVES ONE (1) TIBIAL NAIL-ADVANCED / 10 360 / STERILE THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19533232 ↗
• MalfunctionMay 20, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY TO IMPLANT THE TIBIAL NAIL ADVANCED FOR A LOWER LEG FRACTURE ON (B)(6) 2024. THE NAIL HAD TO BE REMOVED AFTER INSERTION BECAUSE IT WAS FOUND THAT THE PE INLAY WAS TWISTED IN THE DISTAL AREA OF THE NAIL. THE MEDULLARY SPACE WAS TOO NARROW, SO THE IMPLANT WAS REMOVED BEFORE THE MEDULLARY CANAL WAS DRILLED. THE SLIPPED PEEK INLAY WAS DISCOVERED BY CHANCE. THE OPERATION THEN CONTINUED WITH A NEW IMPLANT. SURGICAL DELAY TIME WAS APPROXIMATELY 15-20 MINUTES. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE TIBIAL NAIL-ADVANCED / 10MM 360MM / STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19353697 ↗
• InjuryApr 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON APRIL 3, 2024, THE SUBJECT ID: (B)(6) STUDY NO: (B)(6) WAS REPORTED. THE CLINICAL ADVERSE EVENT RECEIVED WAS FOR A NON UNION ON THE LEFT TIBIA. THERE IS CURRENTLY NO INFORMATION RELATED TO DEVICE OR PROCEDURE RELATEDNESS. DATE OF IMPLANT: (B)(6) 2023. THERE IS NO DATE PROVIDED FOR REVISION. DEPUY SYNTHES PRODUCTS USED: TNA: TIBIAL NAIL, UNKNOWN END CAP, AND UNKNOWN SCREWS (X6). THIS REPORT IS FOR ONE (1) TIBIAL NAIL-ADVANCED / 10 360 / STERILE. THIS IS REPORT 1 OF 8 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 19187891 ↗
• MalfunctionApr 2, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A TIBIAL NAIL IMPLANTATION PROCEDURE ON (B)(6) 2024, THE POLY WAS ON SCREW HOLE AND HAS CAUGHT ON BALL TIP AND WOULD NOT ALLOW NAIL TO GO DOWN. SURGEON TRIED SEVERAL TIME AND THEN TOOK THE WHOLE NAIL AND BALL TIP OUT AND USED A SMALLER NAIL 9/360 INSTEAD. THE SURGERY WAS DELAYED BY TWO (2) HOURS IN ORDER TO GET THE NAIL IN. THIS REPORT IS FOR ONE (1) TIBIAL NAIL-ADVANCED / 10MM 360MM / STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19029037 ↗
• MalfunctionFeb 26, 2024Device Slipped; Device-Device Incompatibility; Device Slipped; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SALES REP INFORMED ABOUT A PATIENT THAT WAS INVOLVED IN A CASE YESTERDAY ON (B)(6) 2024 AROUND 10 PM. THE HOSPITAL CALLED AND THEY WERE TRYING TO PUT IN A TNA NAIL AND AS THEY PUT THE FAULTY NAIL DOWN AND THEN COULDN¿T GET THE BALL TIP OUT AND THEY HAD TO TAKE THE NAIL OUT COMPLETELY AND PUT THE NAIL EX. THE ITEM NUMBER THAT THEY HAVE THE PROBLEM WITH IS 04.043.240S AND THERE WAS BALL TIP REAMING ROD THEY GOT THE NUMBER WHICH WILL BE GIVEN ALL. IT CAUSES INCREDIBLE DELAYS AND THE SALES REP DOESN¿T KNOW ANY OTHER HARM TO THE PATIENT. IT LOOKS THAT THE POLY IN THE NAIL CAME LOOSE AND STUCK ON THE BALL TIP REAMING ROD. THE DEVICE WILL BE RETURNED. THE SALES REP ALSO NEEDS TO HAVE THE COMPANY THE REPLACE THE NAIL AND BALL TIP REAMING ROD PO CHARGE. THIS REPORT IS FOR ONE (1) TIBIAL NAIL-ADVANCED / 10 360 / STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18777530 ↗
• MalfunctionJan 17, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  HOLD FOR RW 1.22. DEVICE REPORT FROM MALAYSIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2023, THE POLYMER INLAY OF THE NAIL IN QUESTION TWISTED, PREVENTING THE SCREWS FROM PASSING THROUGH AS INTENDED. THE TNA WAS REMOVED AND REPLACED WITH ETN, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT IMPACT. THERE WAS A SURGICAL DELAY OF 30 MINUTES, NO FRAGMENTS WERE GENERATED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A TIBIAL NAIL ADVANCED, 10MM 360MM, STERILE. THIS IS REPORT 1 OF 1 FOR PC: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18528998 ↗
• MalfunctionNov 28, 2023Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE ON 21-OCTOBER-2023, THE PEEK INLAY BECAME DISLODGED FROM THE NAIL IN QUESTION. A SECOND NAIL WAS OPENED AND USED TO COMPLETE THE CASE. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT, THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A TIBIAL NAIL-ADVANCED / 10MM 360MM / STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18219669 ↗
• MalfunctionOct 19, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT (B)(6) 2023, DURING TIBIAL NAIL IMPLANTATION THE SURGEON COULD NOT GET PROXIMAL SCREW TO TARGET. WHILE DRILLING ON THE PROXIMAL SCREW OF THE NAIL THE DRILL BIT MISSED CAPTURING THE NAIL ITSELF. THE SURGERY WAS COMPLETED BUT NOT AS THE SURGEON HAD INTENDED. HE HAD TO USE DIFFERENT CONFIGURATION OF LOCKING HOLES TO OBTAIN STABILITY. NO SCREW WAS USED BECAUSE THE DRILL BIT WOULD NOT TARGET THE HOLE. THERE WAS APPROXIMATELY SEVEN (7) MINUTES OF SURGICAL DELAY. THIS REPORT IS FOR ONE (1) TIBIAL NAIL-ADVANCED / 10MM 360MM / STERILE. (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17965854 ↗
• InjuryOct 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY ID: (B)(6). SUBJECT ID: (B)(6). IT WAS REPORTED THAT THE PATIENT EXPERIENCED SYNDESMOTIC FIXATION FAILURE AND NONUNION REQUIRING SURGICAL INTERVENTION. THIS REPORT IS FOR ONE (1) TIBIAL NAIL-ADVANCED / 10 360 / STERILE. THIS IS REPORT 1 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 17896058 ↗
• InjuryAug 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A NON-UNION AND WOUND ISSUE WAS DETECTED THROUGH A POST MARKET STUDY OF A TIBIAL NAIL CONSTRUCT. STUDY ID: DST202103 ID: 00073-008. THE EVENT WAS DETECTED ON (B)(6) 2022 WITH NO EXACT EVENT DATE DETERMINED. NO FURTHER INFORMATION IS KNOWN AT THIS TIME. THIS REPORT IS FOR ONE TIBIAL NAIL-ADVANCED / 10 360 / STERILE FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture; Wound Dehiscence

  MAUDE report 17441300 ↗
• MalfunctionMar 8, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6) 2023, UPON INSERTION OF THE TIBIAL NAIL, THE IMPLANT DID NOT PASS ALL THE WAY DOWN THE IM CANAL OF THE TIBIA TO THE OPTIMAL/EXPECTED LENGTH. IT WAS APPROXIMATELY 1-2CM SHORT OF THE DESIRED LOCATION. THE SURGEON DECIDED TO REMOVE THE NAIL TO REAM A LARGER DIAMETER OF THE CANAL WITH THE PURPOSE BEING TO INSERT THE NAIL MORE EASILY AND TO THE DESIRED LOCATION. UPON REMOVAL OF THE NAIL, THE POLYETHERETHERKETONE (PEEK) INLAY IN THE DISTAL PORTION OF THE NAIL WAS COMING OUT OF THE DISTAL END OF THE NAIL. THE INLAY WAS REMOVED, AND THE NAIL WAS RE-INSERTED SUCCESSFULLY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO OTHER MEDICAL INTERVENTION WAS REQUIRED. THIS REPORT INVOLVES ONE TIBIAL NAIL-ADVANCED / 10MM 360MM / STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16505029 ↗
• InjuryDec 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN ADVERSE EVENT OCCURRED FOR SUBJECT (B)(6) FOR THE DST202103 STUDY. THE PATIENT¿S INITIAL INJURY OCCURRED ON (B)(6) 2022 WITH RIGHT SIDE POLYTRAUMA. TNA WAS IMPLANTED FOR CLOSED DISTAL TIBIA FRACTURE. DATE OF INDEX PROCEDURE WAS (B)(6) 2022. COMPARTMENT SYNDROME WAS NOTED TO HAVE STARTED ON (B)(6) 2022, AND REQUIRED FASCIOTOMIES OF TWO COMPARTMENTS WITH IRRIGATION AND DEBRIDEMENT. THE IMPLANTS WERE NOT REMOVED. THE STATUS OF THE ADVERSE EVENT IS NOW RECOVERING/RESOLVING. THIS REPORT INVOLVES ONE TIBIAL NAIL-ADVANCED / 10MM 360MM / STERILE. THIS IS REPORT 1 OF 7 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15977321 ↗
• InjuryNov 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, SURGICAL INTERVENTION OF SPANNING EXTERNAL FIXATOR WAS PERFORMED BECAUSE OF A NOT PRE-EXISTING FRACTURE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A TIBIAL NAIL-ADVANCED / 10MM 360MM / STERILE. THIS IS REPORT 1 OF 7 FOR (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 15869282 ↗
• MalfunctionAug 9, 2022Material Deformation; Material Deformation

  DEVICE REPORT FROM THE UNITED KINGDOM REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, WHILE INSERTING THE NAIL THROUGH THE REAMING ROD, THE ROD HIT THE PROXIMAL POL INLAY ON THE MOST DISTAL PART. IT SEEMS THE REAMING ROD WENT BEHIND BETWEEN THE NAIL INTERNAL WALL AND POLY INLAY, DEFORMING IT. SURGEONS HAVE ATTEMPTED FEW TIMES TO CHANGE ANGULATION OF DIRECTION WHILE INSERTING THE NAIL THROUGH THE REAMING ROD BUT WAS NOT SUCCESSFUL WITH THE RESULT THAT THE POLY INLAY HAD BEEN DEFORMED AROUND THE MOST DISTAL LOCKING HOLE ON THE PROXIMAL SIZE OF THE NAIL. THE SURGEONS WERE NOT HAPPY TO INSERT THAT NAIL. ANOTHER IMPLANT OF THE SAME SIZE WAS AVAILABLE THEREFORE THEY HAD PROCEEDED INSERTING THE NEW NAIL. SURGEONS HAD FOUND THE SAME ISSUE WITH REAMING ROD GETTING STUCK AT THE POLY INLAY BUT THIS TIME THEY HAD SLIGHTLY BENT DISTALLY THE REAMING ROD SO THAT IT WOULD MATCH THE BEND OF THE NAIL PROXIMALLY, ALLOWING THEM TO PASS THE NAIL THROUGH. THIS REPORT IS FOR A TIBIAL NAIL-ADVANCED / 10MM 360MM / STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15190840 ↗
• MalfunctionJun 9, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON UNKNOWN DATE, THE SURGEON WAS INSERTING THE NAIL OVER THE BALL TIP WIRE, THE PROXIMAL POLY INLAY SLEEVE GOT HUNG UP ON THE TOP OF THE WIRE AND WOULD NOT ALLOW THE NAIL TO ADVANCE. AFTER MULTIPLE TRIES THE INLAY SLID UP THE NAIL AND OUT OF PLACE. THE NAIL WAS REMOVED AND REPLACED WITH ANOTHER NAIL OF SAME DIAMETER AND LENGTH, 10X360 TIBIAL NAIL ANS. CONCOMITANT DEVICE REPORTED: UNK - SCREWS: NAIL PROXIMAL LOCKING (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN), UNK - GUIDES/SLEEVES/AIMING: SLEEVE (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS REPORT IS FOR ONE (1)TIBIAL NAIL-ADVANCED / 10 360 / STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14642330 ↗

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