NA 04.043.135SRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10886982297631), received between Dec 22, 2021 and May 13, 2025 — classified as 3 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (7 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 13, 2025Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2025 AFTER REMOVAL, THE POLY SLEEVE WAS DISENGAGED INSIDE THE TIBIA CANAL. UPON ADDITIONAL REAMING, THE REAMERS COULD NOT PASS DUE TO THE LOST POLY SLEEVE WHICH WAS BLOCKING THE CANAL. THE POLY SLEEVE WAS REMOVED THROUGH THE FRACTURE SITE. REAMINMG PROCEEDED, AND A NEW NAIL WAS IMPLANTED. THERE WAS NO PATIENT STATUS/ OUTCOME / CONSEQUENCES. ITEM = 04.043.1355 X1 TIBIAL NAIL-ADVANCED / 9MM 345MM / STERILE, LOT#23453P1.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22011833 ↗
• InjuryApr 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025 THE PATIENT HAD A HARDWARE REMOVAL OF PLATE AND NAIL. THE REVISION PROCEDURE WAS DUE TO MALUNION/NON-UNION.

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

  MAUDE report 21895622 ↗
• InjurySep 4, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024, SALES CONSULTANT REPORTED THAT, REPRESENTATIVE RECEIVED A TEXT FROM THE SURGEON THAT INCLUDED THE ATTACHED PICTURE. IT IS SHOWING A TNA NAIL THAT HAS BROKEN, APPROXIMATELY 3 WEEKS OUT FROM THE INDEX SURGERY. IT APPEARS TO HAVE BROKEN AT THE LOCATION OF A HOLE IN THE DISTAL CLUSTER THAT WAS EMPTY (NO SCREW INSERTED). THIS IS REPORT 1 OF 1 TIBIAL NAIL-ADVANCED / 9 345 / STERILE FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 20142031 ↗
• MalfunctionJun 27, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6)2023, WHILE ATTEMPTING TO DRILL FOR PROXIMAL LOCKING SCREWS FOR A TIBIAL NAIL ADVANCED (TNA) NAIL IN THE S1 HOLE, THE DRILL BIT HIT THE NAIL. THE NAIL WAS NOT ALIGNED PROPERLY. THE SURGEON CHECKED THE NAIL FOR TIGHTNESS AND WAS ABLE TO GET A TURN TO TIGHTEN THE NAIL. SURGEON DETERMINED THAT THE NAIL LIKELY MISALIGNED BECAUSE IT BECAME LOOSE FROM THE HANDLE. THEY WERE ULTIMATELY ABLE TO GET THE DRILL BIT AND SCREW THROUGH THE NAIL. ADDITIONALLY THE T-HANDLE CHUCK SEEMED TO TURN FREELY WHEN IT SHOULD HAVE BEEN TIGHT. THE DRILL TIPPED K-WIRE ALSO WAS DIFFICULT TO REMOVE FROM THE INSIDE OF THE OPENING DRILL BIT. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH A FIFTEEN MINUTE DELAY. THERE WAS NO PATIENT CONSEQUENCE; PATIENT WAS STABLE. THIS REPORT IS FOR A TIBIAL NAIL-ADVANCED / 9MM 345MM / STERILE. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17210398 ↗
• MalfunctionJun 5, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON MAY 20, 2023 WHILE INSERTING A TIBIAL NAIL ADVANCED OVER A REAMING ROD, THE NAIL WOULD NOT ADVANCE OVER THE ROD PAST THE MOST DISTAL PROXIMAL LOCKING HOLE. THE REAMING ROD WAS HOTTING THE PEEK INSIDE THE NAIL AND WOULD NOT PASS OVER THE REAMING ROD. BECAUSE OF THIS, THE PROXIMAL PEEK WAS MOVED OUT OF ALIGNMENT. THEREFORE ANOTHER TIBIAL NAIL ADVANCED OF THE SAME SIZE WAS OPEN. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH OUT ANY SURGICAL DELAY. NO FRAGMENTS GENERATED. THIS REPORT IS FOR ONE (1) TIBIAL NAIL-ADVANCED / 9MM 345MM / STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17062769 ↗
• InjuryFeb 27, 2023Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2023, THE SURGEON WAS TAKING A PATIENT BACK FOR AN I&D NAIL REMOVAL DUE TO INFECTION. PATIENT WAS HAVING REPETITIVE DRAINING AT ONE OF THE DISTAL LOCKING HOLE SITES. UPON CULTURES THE SURGEON DECIDED TO TAKE THE PATIENT BACK TO REMOVE THE NAIL. WHEN OPENING UP AT THE SITE, SURGEON FOUND PART OF THE POLYMER FOR A TIBIAL NAIL ADVANCE OUTSIDE OF THE NAIL EMBEDDED IN THE BONE PRESSING ON THE SKIN. THE SURGEON TOOK PICTURES AND REMOVED THE NAIL. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THIS REPORT IS FOR ONE (1) THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 16447225 ↗
• MalfunctionNov 14, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM THE UNITED KINGDOM REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2022, THE TIBIAL NAIL IN QUESTION WOULD NOT PASS OVER THE REAMING ROD WITHOUT CATCHING. THE NAIL WAS REMOVED FROM THE JIG AND THE POLY INLAY CAME OUT WITH THE CONNECTING SCREW. THE OPERATION CONTINUED USING ANOTHER PRODUCT, THERE WAS NO ADVERSE PATIENT IMPACT REPORTED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A TIBIAL NAIL-ADVANCED / 9MM 345MM / STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15788384 ↗
• MalfunctionAug 16, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON (B)(6) 2022,THAT THEY WERE TRYING TO PUT IN A TFNA TIBIA NAIL AND THE STATIC LOCKING HOLE COULD NOT GO THROUGH FOR SOME REASON. WE WERE ABLE TO DRILL TO OTHER HOLES. THE NAIL IS STILL ON THE PATIENT. PATIENT IS INVOLVED. THIS REPORT IS FOR ONE (1) TIBIAL NAIL-ADVANCED / 9 345 / STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15236785 ↗
• MalfunctionJun 29, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE USA AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE OF (B)(6) 2022, SURGEON IMPLANTED A TIBIA NAIL ADVANCED USING A SUPRAPATELLAR APPROACH WITH THE LEG PARTIALLY EXTENDED ON A BONE FOAM RAMP POSITIONER. 3 INTERLOCK SCREWS WERE IMPLANTED IN THE DISTAL PART OF THE NAIL THEN THE NAIL WAS "BACKSLAPPED" TO REDUCE AND COMPRESS THE FRACTURE. THE PROXIMAL SCREW GUIDE WAS ATTACHED AND THE STATIC PART OF THE OBLONG HOLE WAS DRILLED. THE DRILL HIT THE NAIL SUPERIOR AND POSTERIOR TO THE SCREW HOLE AND SURGEON COULD NOT PASS THE DRILL THROUGH THE NAIL. THE DRILL AND THE DRILL GUIDES WERE REMOVED AND REATTACHED WITH A SECOND ATTEMPT WITH THE SAME RESULT. WE THEN ATTEMPTED TO DRILL THE MORE PROXIMAL TRANSVERSE STATIC HOLE WITH THE SAME RESULT. THE DRILL HIT THE NAIL AND WOULD NOT PASS THROUGH THE SCREW HOLE. AFTER WHICH THE GUIDE WAS REMOVED AND WE USED THE "PERFECT CIRCLES" TECHNIQUE WITH X-RAY TO FIND AND DRILL THE PATH FOR THE SCREWS. IT WAS UNKNOWN WHEN WAS THE ISSUE OBSERVED. PATIENT CONSEQUENCES IS UNKNOWN. CONCOMITANT DEVICES REPORTED: UNK - SCREWS: NAIL PROXIMAL LOCKING (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 3); UNK - DRILL BITS:

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14852722 ↗
• MalfunctionDec 22, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021, THE AIMING ARM OF THE TN-A MISSED THE DISTAL HOLE AND HAD TO FREE HAND DRILL TO INSERT THE SCREW. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH FIFTEEN (15) MINUTES OF SURGICAL DELAY. CONCOMITANT DEVICE REPORTED: LOCKING SCREW FOR MEDULLARY NAILS, LOW PROFILE, 5 MM (PART # 04.045.338; LOT # UNKNOWN; QUANTITY: 1). LOCKING SCREW FOR MEDULLARY NAILS, LOW PROFILE, 5 MM (PART # 04.045.334; LOT # UNKNOWN; QUANTITY: 1). LOCKING SCREW FOR MEDULLARY NAILS, LOW PROFILE, 5 MM (PART # 04.045.340; LOT # UNKNOWN; QUANTITY: 1). UNK - DRILL (PART # UNKNOWN; LOT # UNKNOWN; QUANTITY: UNKNOWN). THIS REPORT IS FOR ONE (1) TIBIAL NAIL-ADVANCED / 9 345 / STERILE. THIS IS REPORT 3 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13060798 ↗
• MalfunctionDec 22, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021, THE AIMING ARM OF THE TN-A MISSED THE DISTAL HOLE AND HAD TO FREE HAND DRILL TO INSERT THE SCREW. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH FIFTEEN (15) MINUTES OF SURGICAL DELAY. CONCOMITANT DEVICE REPORTED: LOCKING SCREW FOR MEDULLARY NAILS, LOW PROFILE, 5 MM (PART # 04.045.338; LOT # UNKNOWN; QUANTITY: 1), LOCKING SCREW FOR MEDULLARY NAILS, LOW PROFILE, 5 MM (PART # 04.045.334; LOT # UNKNOWN; QUANTITY: 1), LOCKING SCREW FOR MEDULLARY NAILS, LOW PROFILE, 5 MM (PART # 04.045.340; LOT # UNKNOWN; QUANTITY: 1) , UNK - DRILL (PART # UNKNOWN; LOT # UNKNOWN; QUANTITY: UNKNOWN). THIS REPORT IS FOR ONE (1) TIBIAL NAIL-ADVANCED / 9 345 / STERILE. THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13060789 ↗

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