T2 1806-3025Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04546540414588), received between Jun 25, 2018 and Jan 8, 2025 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJan 8, 2025Break; Fracture; Break; Fracture

  AS REPORTED: "THE SURGEON WAS DRILLING TO POSITION THE SECOND CERVICAL SCREW OF A RECONSTRUCTION NAIL WHEN THE DRILL BIT BROKE, LEAVING THE END OF THE DEVICE IN THE FEMORAL NECK. INCREASED ANESTHESIA TIME, WHILE A SOLUTION WAS FOUND TO REMOVE THE BROKEN END. REMOVAL OF DEVICE." THE PROCEDURE WAS DELAYED BY BETWEEN 30 AND 45 MINUTES. THE ALIGNMENT OF THE DRILL IN THE NAIL HOLE WAS CHECKED BEFORE THE NAIL WAS PLACED. FREEHAND EXTRACTION: THE BROKEN BIT FOLLOWED THE GUIDE PIN WHEN THE OPERATOR REMOVED IT BY HAND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21100495 ↗
• InjuryOct 27, 2023Break; Fracture; Break; Fracture

  AS REPORTED: "STEPDRILL 1806-3025 BREAKS DURING SURGICAL PROCEDURE, LEAVING THE TIP INSIDE THE PATIENT."

  Patient problems: Foreign Body In Patient

  MAUDE report 18022655 ↗
• MalfunctionSep 18, 2020Fracture; Fracture

  THE CUSTOMER REPORTED THE FOLLOWING: INCIDENT DESCRIPTION : DURING A FEMORAL OSTEOSYNTHESIS, DURING A CHANGE OF T2 RECON NAIL, THE DRILL BIT BROKE IN THE PATIENT'S FEMUR. DIFFERENT SOLUTIONS SEARCHED TO EXTRACT THIS , BLOCKED IN THE COLLAR PATIENT'S FEMUR. DRILL BIT FINALLY EXTRACTED, THANKS TO A PREHENSIVE FORCEPS ARTHROSCOPY. THE OPERATION COULD THEN BE CONTINUED WITHOUT INCIDENT. THE DRILLING HAVING BEEN DONE, NO FURTHER DEVICE USED [...] DELAY : 1H30, ANESTHESIA DELAYED NO IMMEDIATE CONSEQUENCES ON THE PATIENT".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10553955 ↗
• InjurySep 14, 2020Fracture; Fracture

  SALES REP REPORTED THAT : "FITTING A T2 RECON NAIL, DRILL FOR CEPHALIC SCREW. THE DRILL BIT BROKE INTO SEVERAL PIECES IN THE PATIENT'S FEMUR. THE LARGEST PARTS WERE REMOVED. OTHER BOXES OPENED. DELAY: 2HOURS".

  Patient problems: Foreign Body In Patient

  MAUDE report 10532177 ↗
• MalfunctionFeb 7, 2020Fracture; Fracture

  IT WAS REPORTED: DURING FEMORAL INTRAMEDULLARY NAIL SURGERY THE TOP OF STEPDRILL FOR LAG SCREW WAS FRACTURE. SURGEON TRIED DIFFERENT WAYS TO REMOVE BROKEN PIECE. FINALLY, OPERATION WAS FAILURE. THE BROKEN PIECE REMAINED IN PATIENT BODY. AS OPERATIVE PLAN, THERE TWO SCREWS SHOULD IMPLANT. BECAUSE, THE BROKEN PIECE TOOK SCREW POSITION. FINALLY, ONLY ONE SCREW IMPLANTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9684864 ↗
• InjuryFeb 13, 2019Break

  BREAKAGE OF THE CEPHALIC REAMER DURING REAMING OF THE FEMORAL NECK. THE SURGEON MADE SECTION ON THE SPOT TO RECOVER THE PIECE. SURGICAL DELAY: 90 MIN.

  Patient problems: No Code Available

  MAUDE report 8337606 ↗
• MalfunctionJun 25, 2018Break

  PRIMARY PROCEDURE, RIGHT FEMUR. IT WAS REPORTED THAT IN USING A CANNULATED LAG SCREW STEP DRILL WITH GUIDE WIRE, THE DRILL BIT BROKE OFF IN PATIENT'S BONE. SURGEON WAS ABLE TO REMOVE THE PIECE AND VERIFY REMOVAL BY USE OF C-ARM. A SURGICAL DELAY OF APPROXIMATELY 20 MINUTES WAS REPORTED. PATIENT'S BONE QUALITY WAS NOT REPORTED TO THE REP.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7636389 ↗