NA 04.043.235SRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10886982297785), received between Oct 27, 2022 and Sep 25, 2026 — classified as 6 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Break” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Use of Device Problem

  It was reported that during implantation of the tibial nail, the surgeon identified that the PEEK inlay in the distal portion of complained Tibial Nail Advanced ø10 L was missing. The nail was removed and replaced with a new nail. There was no patient harm or surgical delay.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50900386 ↗
• MalfunctionFeb 26, 2026Material Integrity Problem; Migration

  IT WAS REPORTED DURING A COMPLICATED TIBIA NAIL ADVANCED, THE INSERTION AND REMOVAL OF THE IMPLANT MULTIPLE TIMES, WAS REQUIRED. UPON REMOVAL FOR THE THIRD TIME USER NOTICED THE PEEK INLAY THAT WAS BUILT INTO THE DISTAL PART OF THE NAIL WAS SEVERELY DAMAGED AND ROTATED, MAKING IT UNUSABLE. WITH THAT USER HAD TO OPEN ANOTHER IMPLANT TO CONTINUE THE SURGERY TO COMPLETION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24454821 ↗
• InjuryDec 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR DEEP VEIN THROMBOSIS RESULTING IN PULMONARY EMBOLISM DEVICE RELATED: NO INFORMATION PROVIDED. PROCEDURE RELATED: NO INFORMATION PROVIDED. DATE OF EVENT: 08-AUG-2023. DATE OF IMPLANT: (B)(6) 2023. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: LEFT. TREATMENT/IMPACT: REQUIRED IN-PATIENT HOSPITALIZATION OR PROLONGATION OF EXISTING HOSPITALIZATION, ORAL/TOPICAL MEDICATION (ELIQUIS). TREATMENT/IMPACT: OUTCOME: RECOVERED/RESOLVED. DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 04.043.235S. LOT NUMBER: 3743P43. COMPONENT TYPE: TIBIAL NAIL. DESCRIPTION: TIBIAL NAIL-ADVANCED / 10MM 345MM / STERILE. CATALOG NUMBER: NO INFORMATION PROVIDED. LOT NUMBER: NO INFORMATION PROVIDED. COMPONENT TYPE: LOCKING SCREWS. DESCRIPTION: NO INFORMATION PROVIDED. CATALOG NUMBER: NO INFORMATION PROVIDED. LOT NUMBER: NO INFORMATION PROVIDED. COMPONENT TYPE: LOW PROFILE LOCKING SCREWS. DESCRIPTION: NO INFORMATION PROVIDED. CATALOG NUMBER: NO INFORMATION PROVIDED. LOT NUMBER: NO INFORMATION PROVIDED. COMPONENT TYPE: LOW PROFILE LOCKING SCREWS. DESCRIPTION: NO INFORMATION PROVIDED. CATALOG NUMBER: NO INFORMATION PROVIDED. LOT NUMB

  Patient problems: Thrombosis/Thrombus

  MAUDE report 23770920 ↗
• MalfunctionDec 4, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE PROXIMAL POLYMER HAD A DEFECT AND WOULDN'T ALLOW NAIL TO BE PASSED OVER THE GUIDEWIRE DURING A SURGERY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23720402 ↗
• MalfunctionSep 19, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE INLAY OF THE NAIL IS OUT OF LINE, COULD NOT PLACE BALL TIP WIRE THROUGH THE NAIL. NO PATIENT HARM WAS REPORTED. SURGICAL DELAY WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23094318 ↗
• InjuryApr 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY ID: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR PAINFUL HARDWARE, DEVICE AND PROCEDURE (RELATEDNESS), DEVICE RELATED: NO INFORMATION PROVIDED, PROCEDURE RELATED: NO INFORMATION PROVIDED, DATE OF EVENT: 08 NOV 2024, DATE OF IMPLANT: (B)(6) 2023, DATE OF REVISION: (B)(6) 2025, DEVICE LOCATION: LEFT. TREATMENT/IMPACT: SURGICAL INTERVENTION AT THE FRACTURE SITE, REVISION, INVOLVING ADJUSTMENT, MODIFICATION, REMOVAL OR REPLACEMENT OF ANY REGISTRY NAIL SYSTEM COMPONENTS.

  Patient problems: Pain

  MAUDE report 21900455 ↗
• MalfunctionFeb 10, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT ON (B)(6) 2025 WHEN OPENING THE IMPLANT, THE CIRCULATING NURSE QUESTIONED THE PACKAGING STERILITY (PEELED APART TOO EASILY) WHEN OPENING. ANOTHER IMPLANT WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT STATUS/ OUTCOME / CONSEQUENCES. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21343859 ↗
• InjuryApr 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A STUDY WAS CONDUCTED WHERE A SERIOUS INJURY OF NON-UNION WAS NOTED. STUDY ID: DEPUY - DST202103 SUBJECT ID: (B)(6). ORIGINAL INJURY WAS JULY 11, 2023. PATIENT SUSTAINED A HIGH ENERGY TRAUMA TO THE RIGHT SIDE. A TIBIAL NAILING ADVANCED (TNA) WAS USED. FOUR (4) LOCKING SCREWS WERE USED AS WELL AS THREE (3) LOW PROFILE LOCKING SCREWS. THE SURGICAL DATE WAS (B)(6) 2023. DECEMBER 18, 2023 UNION HAD NOT BEEN ACHIEVED. JANUARY 29, 2024 AP/LATERAL X-RAYS TAKEN; UNION HAD NOT BEEN ACHIEVED AND THE PATIENT INDICATED PAIN WITH INFECTION. (B)(6) 2024, DATE OF REVISION SURGERY. THIS REPORT IS FOR ONE UNK - NAILS: TIBIAL THIS IS REPORT 1 OF 8 FOR COMPLAINT (B)(4).

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

  MAUDE report 19144857 ↗
• InjuryFeb 15, 2024Adverse 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: INFECTION. IS THIS A WORSENING OF AN EXISTING EVENT? NO. CREATION DATE: (B)(6) 2024. SITE AWARENESS DATE: 29-01-2024. THIS REPORT IS FOR A TIBIAL NAIL-ADVANCED / 10MM 345MM / STERILE. THIS IS REPORT 1 OF 8 FOR (B)(4).

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

  MAUDE report 18715726 ↗
• MalfunctionFeb 5, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024, THE SURGICAL STAFF WERE INSERTING A TIBIAL NAIL ADVANCED USING THE EX SUPRAPATELLAR SLEEVES AND THE ANS REAMING GUIDE WIRE. THE SURGEON STARTED TO INSERT THE NAIL THROUGH THE METAL SLEEVE AND WAS REMINDED TO REMOVE THAT FIRST LEAVING THE SILICON SLEEVE ONLY IN PLACE. WHEN THEY PULLED THE NAIL OUT, THE PEEK LINING IN THE DISTAL PART OF THE NAIL FELL OUT AND REMAINED ON THE GUIDE WIRE. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES/OUTCOME. THIS REPORT IS FOR ONE (1) TIBIAL NAIL-ADVANCED / 10MM 345MM / STERILE THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18641539 ↗
• MalfunctionApr 19, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2023, THE SURGEON DECIDED TO PUT A PLATE ON IN CONJUNCTION WITH THE NAIL, SO THE NAIL WAS REMOVED. WHILE WORKING ON THE PLATE IT WAS FOUND THAT THE "PEEK INLAY" HAD DISLODGED FROM THE NAIL. A NEW NAIL WAS OPENED IN REPLACEMENT TO THE MALFUNCTIONING ONE, WHILE INSERTING THIS NAIL THE GUIDE WIRE KEPT "CATCHING" OR RUNNING INTO A LIP ON THE "PEEK INLAY". SURGEON WAS ABLE TO MANEUVER AROUND THE GUIDE ROD, USING A HEMOSTAT, FREER AND THE REST OF THE NAIL INSERTION WAS COMPLETED SUCCESSFULLY. THE INITIAL NAIL THAT MALFUNCTIONED -WITH THE PEEK INLAY DISLODGING - WAS DISPOSED OF. THERE WERE 10 TO 15 MINS OF SURGICAL DELAY. PATIENT OUTCOME WAS UNKNOWN. THIS REPORT INVOLVES ONE (1) TIBIAL NAIL-ADVANCED / 10MM 345MM / STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16768685 ↗
• MalfunctionMar 27, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2023, WHILE TESTING A TNA TO ENSURE THE HOLES LINED UP, THE TROCARS LINED UP PERFECTLY; HOWEVER, IT WAS NOTICED THAT THE NAIL FLEXED AROUND THE SPOT OF THE PROXIMAL BEND AND WAS POTENTIALLY CAUSING THE DRILL BIT TO MISS THE SCREW HOLES. THIS WAS NOT DONE INTRA-OP, ONLY TESTING THE EQUIPMENT WITH AN IMPLANT MARKETING SENT TO THE CONSULTANT. NO ADVERSE EVENTS OCCURRED AND NO PATIENTS WERE INVOLVED. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. THERE WAS NO PATIENT CONSEQUENCES. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) TIBIAL NAIL-ADVANCED / 10 345 / STERILE THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16622562 ↗
• InjuryMar 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NEW AE HAS BEEN REPORTED FOR SUBJECT (B)(6). ADVERSE EVENT TERM: LEFT THIGH HEMATOMA. SITE AWARENESS DATE: (B)(6) 2023. START DATE: (B)(6) 2023. TYPE OF EVENT: LOCAL/FRACTURE SITE. SIDE: LEFT. DEVICE: RFNA. SERIOUS: YES. THIS REPORT IS FOR A TIBIAL NAIL-ADVANCED / 10MM 345MM / STERILE. THIS IS REPORT 4 OF 12 FOR (B)(4).

  Patient problems: Hematoma; Seroma

  MAUDE report 16462164 ↗
• InjuryNov 29, 2022Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2022 PATIENT WENT FOR REMOVAL OF TIBIAL NAIL THAT WAS ORIGINALLY PUT IN AND LEFT PROMINENT. PATIENT WAS COMPLAINING OF PAIN. THERE WAS NO REVISION SURGERY. NAIL WAS REMOVED WITHOUT INCIDENT. PATIENT STATUS/OUTCOME: OK. THIS REPORT IS FOR ONE (1) TIBIAL NAIL-ADVANCED / 10 345 / STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant; Pain

  MAUDE report 15876626 ↗
• MalfunctionOct 27, 2022Break; Break

  IT WAS REPORTED THAT INTRAOPERATIVELY ON (B)(6) 2022 A LINING OF THE TIBIAL NAIL ADVANCED PRODUCT HAS SHREDDED INSIDE THE NAIL. THERE WAS A PATIENT INVOLVEMENT. ANOTHER TN-A/ 10 345/ STERILE WAS AVAILABLE WHICH WAS USED AFTER REALIZING THE INITIAL NAIL WAS DEFECTED. PATIENT IS RECOVERING POST-OPERATIVELY. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) TIBIAL NAIL-ADVANCED / 10MM 345MM / STERILE THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15686428 ↗

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