NA 03.043.024Recalls & reported problems

Summary

The FDA's MAUDE database contains 234 adverse event reports that list this exact device (DI 10886982297235), received between Mar 31, 2022 and Sep 29, 2026 — classified as 234 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (217 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 25 most recent of 234 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Device-Device Incompatibility

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50931957 ↗
• MalfunctionSep 8, 2026Device-Device Incompatibility

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50670486 ↗
• MalfunctionJun 5, 2026Break

  IT WAS REPORTED THAT THE TIBIAL NAIL INSERTION HANDLE (LEFT SIDE) BROKE DURING SURGERY. THERE WAS NO REPORTED PATIENT OR USER HARM. THERE WAS NO SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25415849 ↗
• MalfunctionJun 4, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE CURRENT HANDLES WERE HITTING THE NAIL AND NEED TO BE REPLACED. THERE WAS NO REPORTED PATIENT OR USER HARM. IT WAS UNKNOWN IF THERE WAS A DELAY IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25401658 ↗
• MalfunctionJun 4, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE CURRENT HANDLES WERE HITTING THE NAIL AND NEED TO BE REPLACED. THERE WAS NO REPORTED PATIENT OR USER HARM. IT WAS UNKNOWN IF THERE WAS A DELAY IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25401625 ↗
• MalfunctionJun 4, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE CURRENT HANDLES WERE HITTING THE NAIL AND NEED TO BE REPLACED. THERE WAS NO REPORTED PATIENT OR USER HARM. IT WAS UNKNOWN IF THERE WAS A DELAY IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25401600 ↗
• MalfunctionJun 4, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE CURRENT HANDLES WERE HITTING THE NAIL AND NEED TO BE REPLACED. THERE WAS NO REPORTED PATIENT OR USER HARM. IT WAS UNKNOWN IF THERE WAS A DELAY IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25401578 ↗
• MalfunctionJun 1, 2026Break; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2026, A NEW TNA HANDLE BROKE DURING SURGERY. THE FELLOW TRIED TURNING THE NAIL, HEARD A POP, THEN THE JIG STARTED MISSING THE HOLES IN THE NAIL. AS A RESULT, THE SURGEON HAD TO DO PERFECT CIRCLES PROXIMALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25348959 ↗
• MalfunctionMay 20, 2026Break

  IT WAS REPORTED THAT THE DEVICE HAD A BROKEN TAG ON IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25233681 ↗
• MalfunctionMay 18, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT DURING INSERTION OF A SUPRAPATELLAR NAIL WITH A DISTAL THIRD TIBIAL FRACTURE THE PROXIMAL SCREW HOLES MISTARGETED WHEN DRILLING. WHEN THEY TRIED TO REMOVE THE NAIL THEY COULD NOT UNDO THE CONNECTING SCREW. ALL THIS COMBINED TO ADD SIGNIFICANT TIME TO THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25201707 ↗
• MalfunctionMay 13, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE INSERTION HANDLE MAY HAVE BEEN DAMAGED DURING REMOVAL OF THE CONNECTING SCREW AS IT BECAME ALMOST UNABLE TO TURN OUT. EVENTUALLY IT DISCONNECTED AND NO PATIENT SAFETY ISSUE AROSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25160388 ↗
• MalfunctionMay 7, 2026Device-Device Incompatibility

  WHEN DRILLING THE PROXIMAL MEDIAL TO LATERAL HOLES ON THE NAIL, THE CARBON FIBER AIMING ARM WAS MISALIGNED, LEADING TO A FAIL IN DRILLING USING THE INSTRUMENTATION. THIS CAUSED DELAY IN SURGERY TIME. NO COMPLICATIONS FOR PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25112971 ↗
• MalfunctionMay 1, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE AIMING ARM FOR TIBIA NAIL ADVANCED MISSED THE NAIL. THE ISSUE WAS WITH 03.043.024 WHERE THE SURGEON COULD NOT TARGET THE S2 HOLES FOR PROPER SCREW INSERTION IN THE PROXIMAL PORTION OF THE NAIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25056458 ↗
• MalfunctionMay 1, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE AIMING ARM FOR TIBIA NAIL ADVANCED MISSED THE NAIL. THE ISSUE WAS WITH 03.043.024 WHERE THE SURGEON COULD NOT TARGET THE S2 HOLES FOR PROPER SCREW INSERTION IN THE PROXIMAL PORTION OF THE NAIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25056452 ↗
• MalfunctionApr 20, 2026Device-Device Incompatibility

  IT WAS REPORTED THE PROXIMAL SCREWS WERE MIS-TARGETED DUE AN ISSUE WITH THE SUPRAPATELLAR HANDLE. THE SURGEON TRIED TO ADJUST AS HAS DONE BEFORE BUT IT WOULD NOT TARGET CORRECTLY AND HAD TO DO FREE-HAND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24927533 ↗
• MalfunctionApr 20, 2026Device-Device Incompatibility

  IT WAS REPORTED THE PROXIMAL SCREWS MIS-TARGETED DUE TO AN ISSUE WITH THE SUPRAPATELLAR HANDLE. THE SURGEON TRIED TO ADJUST BUT IT WOULD NOT TARGET CORRECTLY AND SURGEON HAD TO DO COMPLETE PROCEDURE FREE-HAND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24926627 ↗
• MalfunctionApr 15, 2026Device-Device Incompatibility

  IT WAS REPORTED WHILE USING A TIBIAL NAIL ADVANCED BLACK JIG THE SCREW HOLES WERE NOT LINING UP. WHEN THE NURSE ATTACHED THE NAIL TO THE JIG, WE CHECKED THAT THE AIMING ARM WAS SECURE AND THAT THE SCREW HOLES WERE LINING UP USING THE TRIPLE SLEEVES AND THE LONG DRILL BIT. EVERYTHING WAS IN ORDER. AFTER THE SURGEON INSERTED THE NAIL, HE COMPLETED THE DISTAL LOCKING. WHEN HE WENT TO DO THE PROXIMAL LOCKING, THE DRILL BIT WOULD NOT GO THROUGH THE NAIL. WE CHECKED USING XRAY AND THE SCREW HOLES WERE VERY SLIGHTLY OFF WHAT THE JIG WAS AIMING AT. THIS CAUSED A DELAY TO THE SURGERY, AS THE SURGEON HAD TO FIND THE HOLES HIMSELF, WITHOUT USING THE JIG. THE SURGERY WAS DELAYED BY APPROXIMATELY 10 MINUTES. NEEDED TO BE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24887326 ↗
• MalfunctionApr 9, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2026, DURING A PROCEDURE, SURGEON USED A TIBIAL NAIL AND THE PROXIMAL INTERLOCK "MISSED" THE HOLE IN THE NAIL WHEN INSERTING. SURGEON REMOVED THE SCREW, REPOSITIONED AIMING ARM AND INSERTION HANDLE, REDRILLED, THEN REINSERTED THE SCREW THROUGH THE NAIL. THE SURGERY WAS DELAYED BY 10 MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24832914 ↗
• MalfunctionApr 3, 2026Break

  IT WAS REPORTED THAT CARBON FIBER WAS CHIPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24782625 ↗
• MalfunctionApr 1, 2026Device-Device Incompatibility

  IT WAS REPORTED DURING A PROCEDURE THE S1 HIT WITH SUPRAPATELLAR HANDLE, WEBER CLAMPS BROKE, AND 4 POINT TO POINT AND LOBSTERS DID NOT CLICK ALL THE WAY. SURGERY WAS NOT DELAYED DUE TO THE REPORTED EVENT. NO PATIENT CONSEQUENCES. (B)(4) AND (B)(4) ARE RELATED TO EACH OTHER. (B)(4) HAS BEEN CREATED TO CAPTURE THE ANOTHER EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24757258 ↗
• MalfunctionMar 26, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A SUPRAPATELLAR TIBIAL NAIL PROCEDURE THE SUPRAPATELLAR TIBIAL NAIL REPEATEDLY MISSED THE DISTAL STATIC HOLE, PARTICULARLY ON THE RIGHT SIDE. THE ISSUE WAS RESOLVED INTRAOPERATIVELY BY PULLING UP ON THE INSERTION HANDLE, ALLOWING THE NAIL TO FIND THE HOLE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY, AND THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24705905 ↗
• MalfunctionMar 24, 2026Device-Device Incompatibility

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT: WAS THERE ANY SPECIFIC ALLEGATION AGAINST THE UNK - NAILS: TIBIAL? NO. WERE THERE ANY OTHER DEVICES INVOLVED WITH THIS CASE? IF YES PLEASE PROVIDE THE PRODUCT CODE, LOT NUMBER AND ALLEGATION? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24680086 ↗
• MalfunctionMar 20, 2026Device-Device Incompatibility

  IT WAS REPORTED FOR AN INTRA-OPERATIVE EVENT DURING A SUPRA PATELLAR TIBIAL NAIL PROCEDURE. THE COMPLAINT DESCRIBED THAT THE DISTAL STATIC HOLE HAD MISSED ITS TARGET TWO TO THREE TIMES IN A ROW, SPECIFICALLY ON THE RIGHT SIDE. THERE WAS NO REPORTED PATIENT HARM OR SIGNIFICANT DELAY ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24648687 ↗
• MalfunctionMar 11, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A TIBIAL NAIL ADVANCE PROCEDURE, AFTER USING THE COMPRESSION FEATURE WITHIN THE NAIL HANDLE, AND AFTER THE DYNAMIC PROXIMAL SCREW WAS INSERTED, SURGEON ATTEMPTED TO HOLD THE COMPRESSION WITH THE 2ND PROXIMAL STATIC SCREW, BUT THE DRILL BIT HIT THE NAIL AND WAS NOT GOING THROUGH IN ANY MEANS. SURGEON TRIED MINIMAL MANIPULATION MOVING HIS HAND UP AND DOWN, AND EVENTUALLY THE DRILL WENT THROUGH BUT OUTSIDE THE NAIL. THE SURGEON HAD TO REMOVE THE GUIDE ARM AND DRILLED THE HOLE FREE-HAND UNDER X-RAY GUIDANCE. THE EVENT RESULTED IN A 20-MINUTE SURGICAL DELAY AND REQUIRED ADDITIONAL X-RAY IMAGING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED, AND THERE WERE NO REPORTED PATIENT CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24570646 ↗
• MalfunctionMar 3, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT DRILL WAS HITTING NAIL. NO FURTHER INFORMATION IS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24501069 ↗

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-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
• 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