GLOBAL ADVANTAGE 2128-61-007Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295089292), received between Feb 21, 2019 and Apr 4, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Dull, Blunt” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 4, 2019Dull, Blunt; Material Twisted/Bent; Naturally Worn; Scratched Material; Dull, Blunt; Material Twisted/Bent; Naturally Worn; Scratched Material

  IT WAS REPORTED THAT THE SURGEON RECOGNIZED THAT THE FRILL TIP WAS DULL BECAUSE THE SURGEON COULD NOT PERFORM DRILLING (WITH DRILL GUIDE (P/N AND LOT NUMBER WERE UNKNOWN)) TO OPEN THE BONE HOLE TO IMPLANT THE GLENOID COMPONENT INTO THE PATIENT¿S BODY DURING TSA SURGERY. THE SURGEON TRIED TO OPEN THE BONE HOLE WITHOUT DRILL GUIDE, HOWEVER, THE SURGEON COULD NOT OPEN THE BONE HOLE AGAIN. THE SURGERY WAS COMPLETED BY USING ALTERNATIVE DRILL TIP (P/N AND LOT NUMBER WERE UNKNOWN). THERE WAS LESS THAN 30MI. SURGICAL DELAY AND NO HARM TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL.

  Patient problems: Not Applicable

  MAUDE report 8483865 ↗
• MalfunctionFeb 21, 2019Dull, Blunt; Dull, Blunt

  THE FOLLOWING DRILL BITS FROM THE SET GLOBAL AP ARE REPORTED AS DULL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8358613 ↗