NA 2351-3240SRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07613327361698), received between Jan 29, 2021 and Sep 11, 2026 — classified as 4 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Fracture” (10 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. 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50735893 ↗
• MalfunctionNov 13, 2025Fracture; Mechanical Jam; Fracture; Mechanical Jam

  AS REPORTED: "WHEN INSERTING THE GUIDE PIN USING RECON MODE, THE FIRST TIME IT WENT SLIGHTLY FORWARD, SO THE GUIDE PIN WAS PUT BACK, THE DEVICE WAS RAISED AND THE GUIDE PIN WAS INSERTED AGAIN, BUT IT INTERFERED WITH THE NAIL. SO, IT HAD TO BE RE-INSERTED. WHEN THE GUIDE PIN WAS COMPLETELY PULLED OUT AFTERWARDS, THE FRONT END WAS FOUND TO BE BROKEN. IT WAS VERY DIFFICULT TO REMOVE THE TIP, SO THE OPERATION WAS COMPLETED WHILE THE TIP WAS LEFT IN THE PATIENT'S BODY."

  Patient problems: Foreign Body In Patient

  MAUDE report 23541793 ↗
• MalfunctionSep 24, 2025Break; Fracture; Break; Fracture

  AS REPORTED: "THE TIP OF THE DRILL-TIP RECON K-WIRE BROKE OFF. THE BROKEN TIP WAS REMOVED FROM THE PATIENT'S BODY IMMEDIATELY AND THE SURGERY WAS COMPLETED SUCCESSFULLY BY USING ANOTHER GUIDE PIN. IT WAS DETERMINED THAT THIS WAS CAUSED BY MOVING THE K-WIRE BEFORE PULLING IT OUT DURING THE SURGEON'S OPERATION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23137846 ↗
• InjuryMay 9, 2025Break; Fracture; Break; Fracture

  AS REPORTED: "THIS EVENT OCCURRED WHEN THE GUIDE PIN OF THE LAG SCREW WAS INSERTED. THE TIP OF THE GUIDE PIN BROKE INSIDE THE BONE. THE THREAD PART (ABOUT 10MM) OF THE TIP REMAINED INSIDE THE BODY. AFTER THAT DRILLING AND SCREW INSERTION WAS PERFORMED USING A NEW GUIDE PIN".

  Patient problems: Foreign Body In Patient

  MAUDE report 21994546 ↗
• InjuryAug 27, 2024Break; Fracture; Break; Fracture

  THE K-WIRE DRILL BROKE DURING A SURGERY. NEW INFORMATION RECEIVED FROM THE SURGEON/COMPANY REP: EVERYTHING WAS DONE BY THE BOOK, BUT THE K-WIRE WAS NOT IN THE DESIRED POSITION TO PLACE THE RECON SCREW. IT WAS REINSERTED, BUT THEN IT BROKE. FORTUNATELY, A SMALL PIECE WAS STILL PROTRUDING FROM THE BONE, ALLOWING US TO REMOVE THE WIRE, THOUGH IT WAS NOT A QUICK AND EASY PROCESS. THE PATIENT WAS A 76-YEAR-OLD WOMAN OPERATED ON UNDER GENERAL ANESTHESIA.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20073895 ↗
• InjuryJun 27, 2024Break; Fracture; Break; Fracture

  AS REPORTED: ''DURING T2ALPHA SURGERY FOR A FEMORAL FRACTURE, THE TIP OF THE K-WIRE CAME OFF THE HOLE OF THE NAIL AND BROKE OFF DURING REMOVAL. ATTEMPTS WERE MADE TO REMOVE THE BROKEN TIP FROM THE PATIENT BODY, BUT THE SURGEON ULTIMATELY DECIDED TO LEAVE THE TIP INSIDE THE BODY TO COMPLETE THE SURGERY.''

  Patient problems: Foreign Body In Patient

  MAUDE report 19624928 ↗
• MalfunctionApr 7, 2023Break; Fracture; Difficult to Advance; Break; Fracture; Difficult to Advance

  AS REPORTED: "T2ALPHAGT OPERATION WITH RECON MODE. THE PATIENT'S MEDULLARY CAVITY WAS NARROW AND WE REAMED THE DIAPHYSIS 2MM OVER (NAIL USED 10MM LONG 360MM).A DRILL TIP GUIDE WIRE WAS INSERTED DISTAL TO THE RECONTOUR MODE, BUT IT DID NOT GO IN WELL AND HAD TO BE REINSERTED MANY TIMES. IT WAS FOUND THAT THE TIP WAS BROKEN WHEN PULLED OUT THE GUIDE WIRE ALL THE WAY BECAUSE IT MADE A FRICTION SOUND AND CREAKED AGAINST THE METAL. AFTER CHECKING WITH C-ARM, IT TURNED OUT THAT IT WAS STILL INSIDE THE NAIL. WE ATTEMPTED TO REMOVE THE TIP OF GUIDE WIRE BY PULLING OUT THE NAIL HALFWAY, BUT WERE UNABLE TO DO SO, SO WE PULLED OUT THE ENTIRE NAIL. THE SURGEON DECIDED TO LEAVE THE TIP OF GUIDE WIRE INSIDE THE BODY BECAUSE REMOVING THE TIP WOULD DISRUPT THE CURRENT RECONSTRUCTION. WHEN THE NAIL WAS REINSERTED, THE TIP MOVED TO THE DISTAL SIDE AND FINALLY STOPPED A LITTLE MORE PROXIMAL THAN THE DISTAL LATERAL SCREW (THE MOST PROXIMAL POSITION).'

  Patient problems: Foreign Body In Patient

  MAUDE report 16703054 ↗
• MalfunctionFeb 10, 2022Break; Fracture; Break; Fracture

  AS REPORTED: "WHEN INSERTING K-WIRE, THE TIP BROKE OFF ABOUT 3MM AND REMAINED IN THE BONE. THE SURGEON TRIED TO REMOVE IT, BUT COULD NOT."

  Patient problems: Foreign Body In Patient

  MAUDE report 13509864 ↗
• MalfunctionOct 5, 2021Fracture; Fracture

  IT WAS REPORTED APPROXIMATELY 10MM OF K-WIRE BROKE OFF INSIDE THE PATIENT AS THE SURGEON WAS DRILLING IT. THE WIRE WAS LEFT INSIDE THE PATIENT'S BONE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 12579900 ↗
• InjuryJan 29, 2021Difficult or Delayed Positioning; Fracture; Difficult or Delayed Positioning; Fracture

  AS REPORTED: "SURGEON WAS IMPLANTING A T2 ALPHA FEMORAL NAIL-GT (2333-1240S) UTILIZING THE RECON SCREWS. WHILE INSERTING THE DRILL TIP GUIDE WIRE (2351-3240S), IT MISSED THE NAIL. AFTER ATTEMPTING TO RE-INSERT THE GUIDE WIRE, THE TIP BROKE OFF INSIDE THE PATIENT. THE SURGEON WAS UNABLE TO RETRIEVE THE BROKEN PIECE, AND IT REMAINED INSIDE THE PATIENT. ABOUT 5-8MM BROKEN PIECE LEFT INSIDE THE PATIENT. SURGEON DID NOT INSERT RECON SCREWS. INSTEAD IMPLANTED TWO 5.0MM LOCKING SCREWS PROXIMALLY."

  Patient problems: Foreign Body In Patient

  MAUDE report 11250915 ↗