T2 1806-3100Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04546540654939), received between Dec 19, 2018 and Jul 13, 2026 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Failure to Align” (8 reports).

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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 13, 2026Failure to Align; Material Deformation

  AS REPORTED: "THE TARGET BRACKET IS WARPED, AND THE DRILL BIT HITS THE NAIL RIGHT AWAY.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25803860 ↗
• MalfunctionJul 10, 2026Failure to Align

  Patient problems: Insufficient Information

  MAUDE report 25786884 ↗
• MalfunctionJul 10, 2026Failure to Align

  Patient problems: Insufficient Information

  MAUDE report 25785670 ↗
• MalfunctionApr 1, 2026Device Difficult to Setup or Prepare

  AS REPORTED BY THE SALES REP: "THE RECON VERSION OF THE NAIL HOLDER NO LONGER ALIGNS CORRECTLY IN THE FEMORAL NECK, BOTH DURING SURGERY AND WHEN TESTED WITH THE SLEEVES PRIOR TO NAIL INSERTION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24758844 ↗
• MalfunctionFeb 22, 2023Failure to Align; Material Twisted/Bent; Failure to Align; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A CASE THE TARGETING ARM DID NOT HIT THE HOLE IN THE NAIL UPON FIRST ATTEMPT AND THE SURGEON HAD TO RETRY SEVERAL TIMES AND DRILL UNNECESSARY HOLES RESULTING IN A SURGICAL DELAY OF APPROX 30 MIN. THE CASE WAS COMPLETED SUCCESSFULLY; NO HARDWARE WAS LEFT IN THE PATIENT AND A SECOND SURGERY IS NOT REQUIRED. IT WAS LATER OBSERVED THAT THE DEVICE WAS BENT.

  Patient problems: Perforation

  MAUDE report 16417739 ↗
• MalfunctionOct 7, 2022Failure to Align; Failure to Align

  IT WAS REPORTED THAT THE T2 RECON TARGET DEVICE 1806-3100 WAS USED TO INSERT A RECON NAIL. THE TARGET DEVICE DID NOT LINE UP WITH THE HOLE IN THE NAIL, WHICH WAS DISCOVERED AFTER THE NAIL WAS INSERTED INSIDE THE PATIENT. THE NAIL WAS EXTRACTED AND THE TARGET ARM ASSESSED ON THE BACK TABLE. MULTIPLE NAILS WERE THEN ATTACHED TO THE DEVICE IN ORDER TO TROUBLESHOOT. THE LEFT ANTEGRADE HOLE IN THE TARGET ARM IS OFF AIM BY 1CM DISTAL TO THE HOLE IN THE NAIL. THE RIGHT ANTEGRADE HOLE IN THE TARGET ARM IS OFF BY LESS THAN 1MM, WHICH ALLOWS PASSAGE OF THE DRILL THROUGH THE NAIL BUT ONLY WITH RESISTANCE AND DIFFICULTY. RECON MODE WAS THEN SELECTED WITH SUCCESS, AS THESE HOLES ARE UNAFFECTED. ADDITIONAL INFO: "THE ANTEGRADE NAILING WAS NOT ABLE TO BE COMPLETED SUCCESSFULLY DUE TO THE FAILURE OF THE TARGETING GUIDE. HOWEVER, A RECON NAILING OF THE FEMUR WAS ABLE TO BE PERFORMED SUCCESSFULLY. THIS ALTERNATIVE SURGERY WAS NOT PLAN A, AND DID COMPROMISE THE INTEGRITY OF THE PATIENTS FEMORAL HEAD WHEN NOT INITIALLY REQUIRED TO BE COMPROMISED. BUT THE RESULT IS THAT THE PATIENT WILL NOT NEED TO BE RE-SCHEDULED FOR SURGERY. IN SUMMARY, THE INITIAL SURGERY WAS NOT SUCCESSFUL, BUT THE ALTERNATIVE SURG

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15562521 ↗
• MalfunctionJul 15, 2022Failure to Align; Failure to Align

  IT WAS REPORTED THAT "THE RECON TARGETING ARM CAUSED THE DRILL TO MISS BOTH ANTEGRADE AND RECON MODE SCREWS." SURGEON HAD TO USE RECON SCREWS INSTEAD OF ANTEGRADE ON A YOUNG PATIENT. SURGEON HAD TO FREEHAND LOCK THE RECON SCREWS. THERE WAS A SURGICAL DELAY OF 60 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15034003 ↗
• MalfunctionDec 8, 2021Failure to Align; Failure to Align

  IT WAS REPORTED THE FOLLOWING: "ONE WIRE BROKE AND WE MISS THE JIG THREE TIMES AT THE VERY END AFTER MANY ATTEMPTS THROUGHOUT THE SURGERY. THE BROKEN WIRE INTRA OP THAT WE COULD NOT REMOVE, AND ALSO, A MISSING ATTEMPT TO PASS THE WIRE THROUGH THE NAIL X3. ". UPDATE : ((B)(6) 2021) . THE PROCEDURE WAS COMPLETED SUCCESSFULLY. HOWEVER, ONLY ONE SCREW WAS PLACED ON THE FEMORAL HEAD, AS THE BROKEN WIRE WAS ON THE TRAJECTORY OF THE SECOND SCREW. THE PROCEDURE WAS DELAYED BY 42 MINUTES.

  Patient problems: Foreign Body In Patient

  MAUDE report 12959443 ↗
• InjuryJun 9, 2021Failure to Align; Failure to Align

  THE CUSTOMER REPORTED THAT THE PATIENT PRESENTED WITH PAIN 6 WEEKS AFTER IMPLANTATION WITH A T2 NAIL. ON X-RAY IT WAS NOTED THAT THE SCREWS HAD NOT GONE THROUGH THE NAIL. THE SURGEON CHECKED THE TARGET DEVICE PRIOR TO THE CASE AND ALSO AFTER THE CASE. THE CUSTOMER WOULD LIKE THE JIG TO BE INSPECTED. NEW INFORMATION AND CORRECTIONS RECEIVED 27/05/2021. ACCORDING TO THE ADVERSE INCIDENT REPORT: PROXIMAL DISPLACEMENT OF NAIL. PATIENT UNDERWENT RECON NAILING OF HIS RIGHT FEMUR ON (B)(6) 2021. THERE WERE NO NOTICED COMPLICATIONS DURING THE PROCEDURE. CHECK X-RAY WAS TAKEN ON (B)(6) 2021 NO SIGNIFICANT PROBLEM WAS IDENTIFIED. PATIENT REVIEWED AT CLINIC ON (B)(6) 2021. CHECK X-RAY TAKEN SHOWED THAT THERE HAD BEEN PROXIMAL DISPLACEMENT OF THE NAIL WITH SOME COLLAPSE AND ROTATION AT THE FRACTURE SITE. THIS WAS IN KEEPING WITH THE PROXIMAL LOCKING SCREWS NOT BEING THROUGH THE NAIL (ALLOWING PROXIMAL MIGRATION OF THE NAIL). THE PATIENT WAS ALSO SENT FOR AN ADDITIONAL TRUE LATERAL OF THE HIP AT THAT APPOINTMENT. PATIENT EXAMINED AND IT WAS NOTED THAT THE LEG WAS APPROXIMATELY 2CM SHORT WITH SOME SLIGHT EXTERNAL ROTATION OF THE FOOT. PATIENT HAS SUBSEQUENTLY HAD REVISION SURGERY IN RVH.

  Patient problems: Failure of Implant; Implant Pain; Unequal Limb Length

  MAUDE report 11966698 ↗
• MalfunctionFeb 21, 2019Accessory Incompatible; Break; Entrapment of Device

  CUSTOMER REPORTED THAT WHILST USING T2 RECON NAIL, THE REGISTRAR AND SCRUB TESTED TO SEE IF THEY LINED UP WITH THE JIG. THEY TOOK AN X-RAY AND EVERYTHING SEEMED OK, THEREFORE PROCEEDED TO DRILL THROUGH THE CANAL. WHEN LOOKING AT THE LATERAL VIEW X-RAY, THEY REALIZED THE SCREW MISSED THE NAIL. THEY REMOVED THE 2 SCREWS AND ADJUSTED THE NAIL TO TRY AGAIN, BUT THE K-WIRE HIT THE NAIL AND SMALL PIECE OF WIRE BROKE OFF. THIS WAS LEFT IN THE PATIENT AND THEY DECIDED NOT TO CONTINUE THIS METHOD. THEY SUCCESSFULLY COMPLETED THE SURGERY USING ANTEGRADE TECHNIQUE BY PUTTING THE SCREW THROUGH THE LESSER TROCHANTER. THERE WAS A 45 MINUTE DELAY. DELAY OF 45 MINUTES, UNINTENDED METAL (K-WIRE) LEFT IN PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque; Failure of Implant

  MAUDE report 8359171 ↗
• MalfunctionDec 19, 2018Break

  CUSTOMER REPORTED THAT WHILST USING T2 RECON NAIL, THE REGISTRAR AND SCRUB TESTED TO SEE IF THEY LINED UP WITH THE JIG. THEY TOOK AN X-RAY AND EVERYTHING SEEMED OK, THEREFORE PROCEEDED TO DRILL THROUGH THE CANAL. WHEN LOOKING AT THE LATERAL VIEW X-RAY, THEY REALIZED THE SCREW MISSED THE NAIL. THEY REMOVED THE 2 SCREWS AND ADJUSTED THE NAIL TO TRY AGAIN, BUT THE K-WIRE HIT THE NAIL AND SMALL PIECE OF WIRE BROKE OFF. THIS WAS LEFT IN THE PATIENT AND THEY DECIDED NOT TO CONTINUE THIS METHOD. THEY SUCCESSFULLY COMPLETED THE SURGERY USING ANTEGRADE TECHNIQUE BY PUTTING THE SCREW THROUGH THE LESSER TROCHANTER. THERE WAS A 45 MINUTE DELAY. DELAY OF 45 MINUTES, UNINTENDED METAL (K-WIRE) LEFT IN PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 8182755 ↗