NA 1806-0022Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540195784), received between Dec 12, 2020 and Dec 12, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Residue After Decontamination” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 12, 2020Residue After Decontamination; Residue After Decontamination

  AS REPORTED: "DURING A CASE WHERE A LOAN SET OF T2 HUMERUS WAS BEING USED, IT WAS NOTICED DURING THE CASE THAT THERE WAS AN UNKNOWN SUBSTANCE STUCK TO THE GUIDE WIRE RULER (1806-0022) FROM THE T2 BASIC SHORT TRAY (ITEM: 18069905-T LOT# 4239721). THIS MEANT THE ITEM WAS UNSTERILE AND COULD NOT BE USED. AN ALTERNATIVE MEANS OF MEASURING WAS ADOPTED AND IT CAUSED A SLIGHT DELAY TO SURGERY. THE SURGEON STATED AT THE END OF THE PROCEDURE THAT THE SECONDARY METHOD OF MEASURING WE USED ENDED UP CAUSING AN INACCURATE MEASUREMENT, WHICH MEANT THE T2 HUMERAL NAIL THAT WAS IMPLANTED WAS TOO SHORT. THE IMPLANT WAS NOT CHANGED. NOTICED DURING THE PROCEDURE, JUST BEFORE THE GUIDE WIRE RULER WAS ABOUT TO BE USED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10997119 ↗