GLOBAL ADVANTAGE 2128-62-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10603295089803), received between Aug 10, 2017 and Apr 19, 2022 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (5 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 19, 2022Device-Device Incompatibility; Device-Device Incompatibility

  PIN WAS COLD WELDED INTO HUMERAL CUTTING GUIDE. NO SURGICAL DELAY. NO ADVERSE AFFECTS ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14140836 ↗
• MalfunctionJul 28, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED AS "PRODUCT CODE: 212862100, LOT# NW164287 RECEIVED JUNE 14, 2021. SALESMAN WAS CONTACTED THOUGH A FOLLOW UP, DUE TO THE PRODUCT CODE NOT MATCHING WHAT WAS RECEIVED FOR (B)(4). SALESMAN DID NOT RESPOND. DATABASE WAS SEARCHED AND COULD NOT FIND A MATCH. PLEASE CREATE A NEW COMPLAINT TO ACCOMMODATE THIS DEVICE. ALL FOLLOW-UP SHOULD BE DIRECTED TO T-239. FAILURE: FIXATION PIN STUCK IN THE GUIDE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12242514 ↗
• MalfunctionJul 8, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE LEGEND FIXATION PIN IS STUCK IN CUT GUIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12135992 ↗
• MalfunctionDec 3, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE CUTTING GUIDE NO LONGER ALLOWS SMOOTH PINS FROM ANATOMIC TRAY TO SMOOTHLY GO THROUGH HOLES ON CUTTING GUIDE FOR PIN PLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10937915 ↗
• MalfunctionOct 1, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE LEGEND 2 FIXATION PIN GOT STUCK ON THE CUTTING BLACK WHILE TRYING TO PIN TO THE HUMERAL HEAD. NO SURGICAL DELAY

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10613075 ↗
• MalfunctionJun 30, 2020Break; Break

  IT WAS REPORTED THAT THE PIN SHEERED OFF IN CUTTING GUIDE, UNABLE TO REMOVE. UNABLE TO DETECT LOT NUMBER. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10214279 ↗
• MalfunctionSep 23, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE SURGEON PRE DRILLED PINS WITH A 3.2 MM DRILL BIT. THE DRILL BIT GOT STUCK IN THE SECOND HOLE. WE USED THE CUTTING GUIDE AS PLANNED AND THERE WAS NO DELAY TO THE CASE. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9106629 ↗
• MalfunctionJan 21, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PIN STUCK IN CUT GUIDE HOLE.

  Patient problems: Not Applicable

  MAUDE report 8265763 ↗
• MalfunctionSep 21, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE DRILL BIT STUCK IN CUTTING GUIDE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7897444 ↗
• MalfunctionSep 5, 2018Device-Device Incompatibility; Device-Device Incompatibility

  DAMAGE TO THE FIXATION PIN HOLE. UNABLE TO ASSEMBLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7846384 ↗
• MalfunctionAug 8, 2018Failure to Disconnect; Failure to Disconnect

  IT WAS REPORTED THAT THE PIN BECAME LODGED IN THE RESECTION GUIDE DURING PIN REMOVAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7761346 ↗
• MalfunctionOct 19, 2017Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE FIXATION PIN JAMMED IN THE CUTTING GUIDE WHILE SECURING IT.

  Patient problems: No Information

  MAUDE report 6961523 ↗
• MalfunctionAug 10, 2017Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE DRILL BIT BROKE INSIDE THE ANATOMIC RESECTION GUIDE. IT WAS BROKE DURING SURGERY.

  Patient problems: No Information

  MAUDE report 6784217 ↗