NA 1806-0110Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 04546540196019), received between Aug 17, 2018 and Nov 13, 2025 — classified as 2 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• 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 23550396 ↗
• 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 22872689 ↗
• 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 22872688 ↗
• 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 22872524 ↗
• MalfunctionJul 12, 2023Break; Fracture; Difficult to Remove; Break; Fracture; Difficult to Remove

  AS REPORTED: "THE INSTRUMENT BROKE DURING EXPLANTATION. REPLACEMENT WAS AVAILABLE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17312247 ↗
• InjuryMay 6, 2021Difficult to Insert; Difficult to Insert

  AS REPORTED: "THE CUSTOMER CALLED THE SALES REP DURING SURGERY AND COMPLAINED THAT NONE OF THE INSTRUMENTS ON THE METAL EXTRACTION FIT THE PROXIMAL HUMERAL NAIL. ACCORDING TO THE DOCTOR, HE HAD ALREADY REMOVED THE TRANSVERSE SCREWS, BUT NEITHER THE EXTRACTION ROD NOR THE 6MM CONICAL ADAPTER WOULD GRAB THE PROXIMAL END OF THE NAIL. ALL EFFORTS ON THE PART OF THE SALES REP TO PROVIDE A SATISFACTORY SOLUTION WERE UNSUCCESSFUL. SPECIFICALLY, THE PROBLEM WAS PROBABLY THAT THE ADAPTERS ALWAYS CAME LOOSE WHEN TRYING TO DRIVE THE NAIL OUT. THE SALES REP SUSPECTED THAT THE NAIL WOULD ROTATE WITH IT, SINCE THE TRANSVERSE SCREWS HAD ALREADY BEEN REMOVED - BUT ACCORDING TO THE DOCTOR, THIS WAS NOT THE CASE. THE SALES REP RECEIVED A PICTURE OF THE CONTENTS OF THE ME SET AFTER THE SURGERY - ALL INSTRUMENTS WERE PRESENT." ADDITIONAL INFORMATION: PROXIMAL HUMERUS HAD TO BE SPLIT TO LOOSEN THE NAIL. THE SURGERY TOOK 2 HOURS. ACCORDING TO THE DOCTOR, IF THE PROPER INSTRUMENTS WERE PRESENTED, THE PROCEDURE WOULD HAVE BEEN COMPLETED IN ABOUT 30 TO 45 MINUTES.

  Patient problems: Failure of Implant

  MAUDE report 11787199 ↗
• MalfunctionJul 13, 2020Fracture; Fracture

  AFTER REMOVING T2GTN, THE END CAP COULD BE REMOVED BY THE USUAL PROCEDURE, BUT THE SURGEON COULD NOT PULL THE NAIL OUT WITH SOFT TISSUE OR CALLUS, AND TRIED TO REMOVE IT WITH THE CONICAL EXTRACTOR (18066171), BUT THE INSERTED ANGLE SEEMED BAD, AND THE TIP WAS DAMAGED. IN THIS CASE, IT WAS REPLACED WITH T2ALPHAGT AT THE PSEUDO JOINT AFTER T2GTN. AFTER REMOVING THE NAIL, REAMING WAS DONE UP TO 15 MM AND INSERT A 14 MM DIAMETER NAIL. HOWEVER, THE SURGEON ATTEMPTED TO REMOVE IT IN THE MIDDLE BECAUSE THE NAIL COULD NOT BE INSERTED. THE SURGEON TRIED TO ATTACH THE UNIVERSAL ROD AND REMOVE THE NAIL, BUT THE NAIL DID NOT COME OUT AT ALL, AND WHEN THE SURGEON WAS OPERATING IT WITH A HAMMER SEVERAL TIMES, THE SURGEON BROKE THE THREAD PART OF THE UNIVERSAL ROD. THE SURGEON COULDN'T PULL OUT THE NAIL, SO HE COULD EXPAND THE INSIDE OF THE MEDULLARY CANAL WITH K-WIRE, AND MANAGED TO PULL OUT THE NAIL USING THE UNIVERSAL ROD AT THE HOSPITAL. THE, HE WAS ABLE TO REAM UP TO 16 MM AGAIN AND INSERT A NAIL. WHEN THE STRIKE PLATE WAS ATTACHED TO THE TIP OF THE UNIVERSAL ROD, THE TIP OF THE UNIVERSAL ROD WAS DAMAGED AND LEFT INSIDE THE STRIKE PLATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10268028 ↗
• MalfunctionJun 26, 2020Fracture; Fracture

  AS REPORTED: THE THREADED END OF THE UNIVERSAL ROD WAS BROKEN, AND THE BROKEN PART WAS CAUGHT IN THE EXTRACTION ADAPTER. THE NURSE NOTICED BEFORE THE OPERATION. USING OTHER INSTRUMENTS, THE OPERATION ENDED WITHOUT PROBLEMS. IF THE NURSE DIDN'T NOTICE AND THERE WAS NO SUBSTITUTE, IT WAS A BIG PROBLEM. THERE IS A PROBLEM WITH THE INSPECTION METHOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10203068 ↗
• MalfunctionMay 19, 2020Fracture; Fracture

  IT WAS REPORTED, WHEN THE U-BLADE ADAPTER WAS MANUALLY ATTACHED TO THE UNIVERSAL ROD, THE THREADED PORTION AT THE END OF THE UNIVERSAL ROD WAS DAMAGED, AND THE BROKEN PIECE WAS CAUGHT IN THE U-BLADE ADAPTER, MAKING IT UNUSABLE. INSTRUMENTS IN THE HOSPITAL WERE STERILIZED AND USED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10073175 ↗
• MalfunctionApr 15, 2020Break; Break

  THE SALES REP REPORTED, DURING A PRIMARY PROXIMAL FEMUR FRACTURE, WHILE THE SURGEON WAS BACKSLAPPING THE DEVICE BROKE OFF. THE SURGEON STOPPED BACKSLAPPING AND REMOVED THE ROD AND STRAIGHT PLATE AND HIT THE METAL PORTION OF THE JIG TO COMPLETE THE SURGERY. THERE WAS A 2 MINUTE SURGICAL DELAY. THE SURGEON INSPECTED THE GTN AND UNIVERSAL ROD AND NOTICED THE THREADS WERE STRIPPED. ADDITIONALLY REPORTED: "...HE DIDN'T REMOVE THE UNIVERSAL ROD AS HE DIDN'T HAVE TO SINCE THAT'S WHAT BROKE OFF."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9966013 ↗
• MalfunctionMar 4, 2020Material Fragmentation; Material Fragmentation

  IT WAS REPORTED, DURING THE SURGERY WHEN INSERTING A FEMORAL NAIL, THE ROD WAS PLACED ON THE INSERTION HANDLE IN ORDER TO REPOSITION THE NAIL SOMEWHAT PROXIMALLY. WHEN THE NAIL WAS KNOCKED OUT, THE ENTIRE THREAD WAS TORN OUT. THE SURGERY COULD BE FINISHED WITHOUT ANY PROBLEMS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9787956 ↗
• MalfunctionMar 18, 2019Break; Fracture; Improper or Incorrect Procedure or Method; Fracture

  THE STRYKER REP REPORTED THEY WERE SUPPORTING A CASE WHERE THE SURGEON WAS USING THE UNIVERSAL ROD AND REDUCTION. THE SURGEON APPLIED A LOT OF FORCE THROUGH A HAMMER WHICH CAUSED THE DEVICE TO BREAK. THE SPOON PART OF THE INSTRUMENTS BROKE AWAY FROM THE ROD, LEAVING IT IN THE FEMORAL CANAL. THE SPOON WAS RETRIEVED BY OPENING THE FEMUR AT THE FRACTURE SITE, AND THE REP REPORTED THAT THIS WOULD OF HAD TO BE CARRIED OUT TO REDUCE THE FRACTURE ANYWAY. SLIGHT DELAY, NO MORE THAN 5 MINUTES.

  Patient problems: No Code Available

  MAUDE report 8429110 ↗
• MalfunctionFeb 19, 2019Break; Fracture; Fracture

  AFTER SCREWING IN THE UNIVERSAL ROD AND LIGHT KNOCKING, THE ROD BROKE OFF AT THE TOP OF THE THREAD. IT HAD BEEN COMPLETELY SCREWED IN WITHOUT RESISTANCE. THE NAIL IS VERY FIRMLY GROWN IN THE BONE. SURGICAL DELAY OF 2 HOURS. THE METAL REMOVAL DID NOT TAKE PLACE. THE LOCKING SCREWS WERE REPLACED AND THE NAIL LEFT. RENEWED REVISION IS NECESSARY. THE DATE OF THE REVISION IS STILL UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8351725 ↗
• InjuryDec 17, 2018Break

  THE PHARMACIST AT THE HOSPITAL REPORTED THE FOLLOWING EVENT : "I WOULD LIKE TO CONTACT YOU FOR A DECLARATION OF MATERIOVIGILANCE ON A GUIDE FOR NAIL GUIDE T2 (RESTÉRILISABLE MATERIAL REF 1806-0125K134075 / 1806-0110K537887). DURING AN INTERVENTION ON (B)(6) 2018, THE SCREW THREAD CONNECTING THE TWO PARTS OF THE GUIDE BROKE IN THE FEMORAL SHAFT DURING THE ATTEMPT TO REDUCE A FEMORAL FRACTURE, RESULTING IN AN ADDITIONAL INCISION ON THE LEG TO BE ABLE TO ACCESS THE LOWER END OF THE INSTRUMENT IN ORDER TO BE ABLE TO REMOVE IT. AN ADDITIONAL INCISION HAD TO BE MADE ON THE LEG TO GAIN ACCESS TO THE LOWER END OF THE INSTRUMENT IN ORDER TO REMOVE IT.

  Patient problems: Foreign Body In Patient

  MAUDE report 8171155 ↗
• MalfunctionAug 17, 2018Break; Fitting Problem

  THREAD OF THE UNIVERSAL ROD BROKE APART. AFTER THE THREAD OF THE ROD WAS BROKEN OFF, THE CONICAL ATTACHMENT NO LONGER FITS.

  Patient problems: No Information

  MAUDE report 7792704 ↗