NA 1806-0150Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 04546540196088), received between Mar 28, 2019 and Nov 18, 2025 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Break” (13 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 18, 2025Device Difficult to Setup or Prepare; Material Deformation; Device Difficult to Setup or Prepare; Material Deformation

  AS REPORTED: "DURING PRIMARY ORIF (T2) FOR RIGHT FEMORAL SHAFT FRACTURE. THE T2 STRIKE PLATE WAS FITTED TO THE TARGET DEVICE AND INSERTED WHILST STRIKING WITH A HAMMER. AS THE T2 STRIKE PLATE WAS NOT SEATED CORRECTLY WHEN STRUCK, THE THREADED CONNECTION POINT ON THE DEVICE BECAME STRIPPED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23581812 ↗
• MalfunctionNov 13, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  AS REPORTED: "THE UNIVERSAL ROD AND THE T-PIN CAN NO LONGER BE CONNECTED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23550397 ↗
• MalfunctionAug 22, 2025Break; Material Deformation; Break; Material Deformation

  AS REPORTED: "ON MONDAY MORNING THE 28/07 A NURSE REACHED OUT TO REP TO ADVISE HER THAT SEVERAL INSTRUMENTS HAD BROKEN THREADS. THE INSTRUMENTS HAD BEEN USED DURING CASES OVER THE WEEKEND AND NOW LOOKED DAMAGED. THE REP WENT TO INSPECT ALL THE INSTRUMENTS THAT ARE CONSIGNED AND NOTICED SEVERAL BEING BROKEN. NO ISSUES WERE NOTED DURING THESE CASES AND NO IMPACT ON SURGICAL TIME OR OUTCOMES HAVE BEEN REPORTED. ISSUE WAS NOTED AFTER PROCEDURES. IT'S UNCERTAIN WHEN THE DAMAGE OCCURRED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22872690 ↗
• MalfunctionAug 22, 2025Break; Material Deformation; Break; Material Deformation

  AS REPORTED: "ON MONDAY MORNING THE (B)(6) A NURSE REACHED OUT TO REP TO ADVISE HER THAT SEVERAL INSTRUMENTS HAD BROKEN THREADS. THE INSTRUMENTS HAD BEEN USED DURING CASES OVER THE WEEKEND AND NOW LOOKED DAMAGED. THE REP WENT TO INSPECT ALL THE INSTRUMENTS THAT ARE CONSIGNED AND NOTICED SEVERAL BEING BROKEN. NO ISSUES WERE NOTED DURING THESE CASES AND NO IMPACT ON SURGICAL TIME OR OUTCOMES HAVE BEEN REPORTED. ISSUE WAS NOTED AFTER PROCEDURES. IT'S UNCERTAIN WHEN THE DAMAGE OCCURRED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22872687 ↗
• MalfunctionMar 31, 2025Break; Fracture; Break; Fracture

  AS REPORTED: "THE SURGEON HAD PARTIALLY INSERTED THE NAIL (ATTACHED TO JIG). HE THEN DECIDED TO REMOVE THE NAIL - STRIKE PLATE ATTACHED TO JIG AND UNIVERSAL ROD ATTACHED TO STRIKE PLATE, USING SLOTTED HAMMER TO BACKSLAP. THE STRIKE PLATE AND UNIVERSAL ROD CONSTRUCT BECAME DETACHED, WITH THE THREADS OF THE STRIKE PLATE REMAINING IN THE JIG. OUTCOME: THE SURGEON REMOVED THE STRIKE PLATE THREADS FROM THE JIG, I BELIEVE USING A GENERIC 3MM WIRE. HE THEN INSERTED THE UNIVERSAL ROD DIRECTLY INTO THE JIG TO ACT AS A STRIKE PLATE TO REINSERT THE NAIL. ESTIMATED DELAY: LESS THAN 1 MINUTE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21734862 ↗
• MalfunctionFeb 16, 2024Break; Fracture; Break; Fracture

  AS REPORTED BY REP: "STRIKE PLATE SNAPPED FROM THE TARGETING ADAPTER WHILE INSERTING THE NAIL (HITTING THE STRIKE PLATE USING THE HAMMER)".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18727691 ↗
• MalfunctionMay 25, 2023Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THERE WAS A BREAKAGE OF THE STANDARD STRIKE PLATE IMPACTOR THREAD.

  Patient problems: Insufficient Information

  MAUDE report 17003039 ↗
• MalfunctionMay 1, 2023Material Fragmentation; Mechanical Jam; Material Fragmentation; Mechanical Jam

  AS REPORTED: "THE IMPACT TOOL (REF# (B)(6) ) WOULD NOT SCREW INTO THE BRAND NEW T2ALPHA FEMUR TARGETING DEVICE (REF# (B)(6) ) EVEN AFTER SEVERAL ATTEMPTS. EVERYONE INVOLVED AT THE TABLE TRIED. RATHER, METAL SHAVINGS WERE THEN ABRADED, BUT NONE OF THEM DID GET INTO THE PATIENT. HOWEVER, IN ORDER TO THEN DRIVE THE NAIL IN SO AS TO BE ABLE TO PERFORM THE SURGERY, THE SURGEON HAD TO MAKE DO AND HAMMERED THE IMPACTOR INTO THE TARGETING DEVICE.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16849252 ↗
• MalfunctionApr 21, 2023Break; Fracture; Break; Fracture

  AS REPORTED: "AN ALPHA FEMUR ANTEGRADE TARGETER BROKE DURING A CASE. WHEN THE DOCTOR WAS STRIKING THE STRIKE PLATE FROM THE BOTTOM PORTION OF THE TARGETER, WHERE THE WHEEL WAS FLEW OFF. THE STRIKE PLATE AND TARGETER BOTH BROKE. EXCESS FORCE WAS USED. REP HAD ANOTHER STRIKE PLATE AND THE WHEEL DID NOT INTERFERE WITH THE HOLES AT THE BOTTOM OF THE TARGETER. THIS TOOK PLACE DURING A PRIMARY SURGICAL EVENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A 20 MINUTE DELAY. HAD TO MODIFY THE INSTRUMENTATION BECAUSE THE BREAKAGE THREW OFF THE TRAJECTORY OF THE HOLES. NO IMPACT TO THE PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16786907 ↗
• MalfunctionJul 7, 2021Break; Break

  AS REPORTED: "WHEN THE NAIL WAS DRIVEN BACK, THE STRIKE PLATE, THAT WAS SCREWED INTO THE NAIL HOLDING BOLT, BROKE OFF. I COULD OBSERVE THAT THE STRIKE PLATE HAD BEEN SCREWED IN/TIGHTENED FIRMLY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12127041 ↗
• MalfunctionFeb 4, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE SURGEON HIT THE STRIKE PLATE ATTACHED TO THE TARGETING ARM AND AS HE DID SO THE STRIKE PLATE THREADS BROKE INSIDE THE TARGETING ARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11278327 ↗
• MalfunctionOct 8, 2020Positioning Failure; Positioning Failure

  FEMUR TARGET DEVICE 1806-1008/1806-1006, MISSDRILLING. STRIKE PLATE 1806-0150 COULD NOT BE SCREWED IN REPLACEMENT WAS AVAILABLE. SURGICAL DELAY OF 30MIN. NOT LONGER. NO OTHER CONSEQUENCES REPORTED. ADDITIONAL INFORMATION RECEIVED FROM THE OP LEAD: THE MISDRILLING OCCURRED AT THE PROXIMAL END THE ISSUE WAS RESOLVED BY USING SECOND TARGETING ARM AND LATER ORDERED NO PATIENT IMPACT, ONLY 30MIN OP TIME INCREASE THE THREADING OF STRIKE PLATE IMPACTED IN A WAY THAT IT CANNOT BE THREADED INTO THE TARGETING ARM ANYMORE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10653194 ↗
• MalfunctionMar 27, 2020Material Fragmentation; Material Fragmentation

  IT IS REPORTED, METAL ABRASION OCCURRED WHEN CONNECTING THE STRIKE PLATE AND THE NAIL HANDLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9890928 ↗
• MalfunctionNov 6, 2019Break; Fracture; Fracture

  AS REPORTED: "PRIMARY PROCEDURE, RIGHT FEMUR (T2 ALPHA GT). IT WAS REPORTED THAT THE THREADS OF THE T2 STRIKE PLATE (NOT T2 ALPHA) BROKE IN THE T2 ALPHA TARGETING ARM. AS IT WAS NOT KNOWN IF THE THREADED PORTION COULD BE REMOVED, THE TARGETING ARM WAS IMPACTED DIRECTLY. IT WAS FOUND THE THREADED PORTION COULD BE REMOVED, AND A SECOND STRIKE PLATE WAS USED. THERE WAS NO APPARENT DAMAGE TO THE TARGETING ARM." ALSO REPORTED: "SURGERY WAS COMPLETED SUCCESSFULLY WITH AN OVERALL DELAY OF APPROXIMATELY 5 MINUTES." NO ADVERSE CONSEQUENCES REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9288583 ↗
• MalfunctionOct 21, 2019Crack; Fracture; Fracture

  DISTORTION WAS FOUND WHEN THE STRIKE PLATE WAS REMOVED AFTER FIXING THE NAIL. WHEN I WATCHED IT CLOSELY, THERE WAS A CRACK IN THE SCREW HOLE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY OR ADVERSE CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9213370 ↗
• MalfunctionSep 9, 2019Break; Fracture; Fracture

  IT WAS REPORTED THAT THE INSTRUMENT HAS A BROKEN END. NO ASSOCIATED PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8977142 ↗
• MalfunctionSep 3, 2019Break

  AS REPORTED: "DURING AN INTERMEDULLARY NAIL CASE, THE STRIKE PLATE WAS STRIPPED OUT OF THE NAIL ADAPTER COMPLETELY WHILE ATTEMPTING TO BACKSLAP A NAIL OUT. A SECOND STRIKE PLATE WAS THEN USED IN ORDER TO RE-INSERT THE NAIL AND THIS STRIKE PLATE ALSO FAILED. NEITHER THE NAIL ADAPTER OR STRIKE PLATES WERE VIABLE AND WE HAD TO RESORT TO USING THE OLDER T2 SYSTEM. THIS DELAYED THE CASE AND ALSO ENDED UP IN WASTING THE FIRST NAIL".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8958121 ↗
• MalfunctionSep 3, 2019Break; Structural Problem

  AS REPORTED: "DURING AN INTREMEDULLARY NAIL CASE, THE STRIKE PLATE WAS STRIPPED OUT OF THE NAIL ADAPTER COMPLETELY WHILE ATTEMPTING TO BACKSLAP A NAIL OUT. A SECOND STRIKE PLATE WAS THEN USED IN ORDER TO RE-INSERT THE NAIL AND THIS STRIKE PLATE ALSO FAILED. NEITHER THE NAIL ADAPTER OR STRIKE PLATES WERE VIABLE AND WE HAD TO RESORT TO USING THE OLDER T2 SYSTEM. THIS DELAYED THE CASE AND ALSO ENDED UP IN WASTING THE FIRST NAIL".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8958118 ↗
• MalfunctionJul 18, 2019Break; Device Dislodged or Dislocated

  AS REPORTED: "DURING IMPACTION OF THE GTN NAIL, THE STRIKE PLATE BROKE AT THE THREADING INTO TWO PIECES. THE THREADS BECAME LODGED INSIDE OF THE THREADED STRIKE PLATE ATTACHMENT SITE ON THE TARGETER. SLOWED DOWN SURGERY". PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8804974 ↗
• MalfunctionMar 28, 2019Break

  DURING INSERTING THE NAIL, THE STRIKE PLATE BROKE AT THE THREAD. A PART OF THE THREAD REMAINED IN THE TARGET DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8461803 ↗