NA 03.043.019Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10886982297181), received between Aug 19, 2022 and Apr 21, 2025 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (9 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.

• MalfunctionApr 21, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, WHILE DRILLING THROUGH THE AIMING ARM, THE DRILL IS MISSING THE LOCKING SLOT OF THE NAIL CAUSING DELAYS. THERE WAS 7 MIN SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCES. THIS (B)(4) IS RELATED TO (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21877775 ↗
• MalfunctionApr 21, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2025 WHILE DOING A TIBIAL NAIL, THE LENGTH OF THE NAIL WAS TOO LONG SO SURGEON HAD TO EXTRACT THE OLD NAIL. WHILE EXTRACTING THE PREVIOUS NAIL, THE DRIVE CAP PIN FELL OUT WHILE BACKSLAPPING. THE DRIVE CAP WAS UNABLE TO BE REMOVED FROM THE INFRAPATELLAR HANDLE AND IT WAS COLD WELDED. WHILE PLATING THE FIBULA THE DISTAL FIBULAR PLATE WAS USED AND SURGEON WAS UNABLE TO LOCK A SCREW IN THE SHAFT SO IT WAS NOT USED. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21873227 ↗
• MalfunctionFeb 26, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE SURGEON WAS USING THE TNA SYSTEM (INFRAPATELLAR INSTRUMENTATION) IN A SEMI-EXTENDED SURGICAL APPROACH AND THE AIMING ARM WAS MIS-TARGETED.

  Patient problems: Insufficient Information

  MAUDE report 21470407 ↗
• MalfunctionNov 14, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE SALES REP WAS COVERING A TIBIAL NAIL, USING THE INFRAPATELLAR APPROACH. DURING THE CASE, THE AIMING ARM DID NOT APPROPRIATELY TARGET THE STATIC HOLE. THE SURGEON WAS INSTRUCTED TO MANIPULATE THE HANDLE A BIT, AND TIGHTEN THE CONNECTING SCREW, AFTER WHICH TIME THE DRILL BIT WAS ABLE TO GO THROUGH THE HOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20684018 ↗
• MalfunctionOct 25, 2024Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE NAIL WAS LEFT IN THE PATIENT BECAUSE THERE WAS NO WAY TO REMOVE IT WITHOUT FURTHER DAMAGE TO THE PATIENT'S TIBIA. THE INTEGRITY OF THE SHAFT OF THE NAIL SEEMED INTACT AND THE FRACTURE WAS REDUCED. THIS WAS AN INTRAOPERATIVE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 20536129 ↗
• MalfunctionJul 25, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE CUSTOMER IN STERILE PROCESSING NOTIFIED THE REPRESENTATIVE THAT THEY WERE UNABLE TO DECOUPLE TWO ITEMS FROM TIBIAL NAIL ADVANCED SET POST-SURGERY: CONNECTING SCREW, CANNULATED, SHORT AND THE COMPRESSION SCREW, SHORT. THERE WAS NO PATIENT STATUS/ OUTCOME / CONSEQUENCES. THIS REPORT INVOLVES ONE (1) CONNECTING SCREW/ CANNULATED SHORT. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19826812 ↗
• MalfunctionFeb 28, 2024Break; Crack; Break; Crack

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PRODUCTS IN QUESTION WERE UNABLE TO BE STERILIZED AND ASSEMBLED. THERE WAS ALSO CHIPPING AND CRACKING, THEY WERE UNABLE TO BE USED. THERE WAS NO REPORTED PATIENT OR PROCEDURE INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A CONNECTING SCREW/ CANNULATED SHORT. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18798385 ↗
• MalfunctionDec 13, 2023Device-Device Incompatibility; Device-Device Incompatibility

  THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18317434 ↗
• MalfunctionMay 22, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A TNA INFRA APPROACH WAS DONE. NAIL WAS MALLETED IN, AIMING ARM CRACKED. AFTER COMPRESSING WITH COMPRESSION SCREW AND CONNECTING SCREW THE DRILL BIT HIT S1. SURGEON RE REAMED PROXIMALLY AND REAMER GOT SNAGGED PROXIMALLY. IT IS UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) CONNECTING SCREW/ CANNULATED SHORT THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16976385 ↗
• MalfunctionJan 3, 2023Device-Device Incompatibility; Device-Device Incompatibility

  THE EVENT WAS DISCOVERED DURING SURGERY ON (B)(6) 2022, BUT THE CONNECTING SCREW/COMPRESSION DEVICES WERE NOT BEING USED IN THE PROCEDURE. THE PATIENT WAS NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16086964 ↗
• MalfunctionAug 19, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT ON UNKNOWN DATE,AFTER POST OP INSPECTION THE TREYS IN THIS SPECIFIC WASH CYCLE IN CSPD WERE DAMAGED. TWO GRAPHIC CASES WERE SLIMY & APPEARED COVERED WITH A WHITE CHALK TEXTURE THAT WERE UNABLE TO BE REMOVED. INSERTION HANDLE AND CONNECTING SCREW HAD RESIDUE ALONG WITH THE SUPRAPATELLAR GUIDES. THE SURGERY WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS STABLE. THIS REPORT IS FOR ONE (1) CONNECTING SCREW/ CANNULATED SHORT. THIS IS REPORT 1 OF 1 FOR COMPLAINT: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15259135 ↗

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