GLOBAL ADVANTAGE 2128-62-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295089742), received between Oct 13, 2017 and Feb 20, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (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 18, 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 20, 2019Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT WHILE PINNING THE CUTTING GUIDE, A FIXATION PIN BECAME LODGED IN THE GUIDE PREVENTING THE USE OF THE JIG.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8354447 ↗
• MalfunctionDec 18, 2018Entrapment of Device; Entrapment of Device

  THE CUTTING GUIDE WAS WITH A METAL PIECE INSIDE THE HOLE WHERE THE PINS ARE PLACED FOR THE FASTENING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8175096 ↗
• MalfunctionOct 13, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE GUIDE PIN WAS CAUGHT IN THE HOLE OF CUTTING GUIDE IN QUESTION, AND WAS BENT WHEN THE SALESFORCE TRIED TO PASS THE 3.2 GUIDE PIN THROUGH THE HOLE OF THE CUTTING GUIDE IN QUESTION DURING THE WORKSHOP. AND IT WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED.

  Patient problems: No Information

  MAUDE report 6949248 ↗