GLOBAL ADVANTAGE 2128-11-006Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295088318), received between Sep 22, 2017 and Oct 4, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 4, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT SIZE 6 BULLET TIP REAMER WAS DULL.

  Patient problems: Insufficient Information

  MAUDE report 20374165 ↗
• MalfunctionOct 2, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT SIZE 6 BULLET TIP REAMER IS DULL. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20353535 ↗
• MalfunctionNov 23, 2022Failure to Cut; Illegible Information; Failure to Cut; Illegible Information

  IT WAS REPORTED THAT BY THE SURGEON THE REAMERS SZ 6/8/10/12 UNITE COMMON TRAY NEEDS SHARPENING / REPLACE, LOT NUMBERS WORN OFF AND UNABLE TO READ. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15852341 ↗
• MalfunctionSep 22, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING REAMING, THE TIP OF THE REAMER THAT CHUCKS TO THE HANDLE WAS NOT ENGAGING PROPERLY.

  Patient problems: No Information

  MAUDE report 6886499 ↗