NA 1806-0353Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540196446), received between Dec 10, 2018 and Feb 4, 2025 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 4, 2025Break; Fracture; Break; Fracture

  AS REPORTED: "EXTRACTION ROD IS BROKEN OFF AT THE FRONT"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21306908 ↗
• 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 11787190 ↗
• InjuryDec 10, 2018Break

  CUSTOMER REPORTED THAT WHILST USING THE TIMEX LOAN KIT ¿ THE CONICAL EXTRACTION ROD 6MM (1806-0353) BROKE INSIDE OF THE NAIL DURING REMOVAL. PATIENT BOOKED TO UNDERGO FURTHER SURGERY ON (B)(6) 2018. REP WAS NOT PRESENT FOR CASE AND WHEN RECEIVED THE CALL REGARDING THE BREAKAGE THE INSTRUMENT HAD ALREADY BEEN THROWN AWAY.

  Patient problems: No Code Available

  MAUDE report 8148412 ↗