GLOBAL ADVANTAGE 2128-62-110Recalls & reported problems
Depuy (Ireland) · GLOBAL ADVANTAGE + CUTTING GUIDE RIGHT · Class 1
All models of GLOBAL ADVANTAGE (28)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Global Advantage cutting guide is an instrument that helps guide cuts during surgery. Reports mostly describe pins sticking, jamming or breaking in the guide holes, sometimes so a pin cannot pass through. There are 24 reports, with no deaths and no injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 24
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10603295089810), received between Mar 7, 2018 and Jan 9, 2025 — classified as 24 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (11 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.
Reports received per month
Most reported problems
Device problems
- Device-Device Incompatibility11
- Difficult to Remove3
- Mechanical Jam3
- Physical Resistance/Sticking3
- Appropriate Device Problem Term/Code Not Available2
- Material Deformation2
- Break1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions10
- No Consequences Or Impact To Patient10
- No Code Available4
- Not Applicable2
- Insufficient Information1
Recent adverse event reports
The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 9, 2025Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT THE PIN HOLE IS JAMMED AND WON¿T PIN CORRECTLY. NO FURTHER DETAILS WERE PROVIDED.
Patient problems: Insufficient Information
MAUDE report 21110708 ↗MalfunctionJun 14, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT DURING THE PRIMARY ANATOMIC TOTAL SHOULDER ARTHROPLASTY, THE SURGEON WAS UNABLE TO DRILL A PIN THROUGH ONE OF THE PIN HOLES OF THE RIGHT CUTTING GUIDE BECAUSE THE HOLE WAS BROKEN SUCH THAT A PIN COULD NOT FIT THROUGH. THERE WAS NO DELAY OR COMPLICATION TO THE SURGERY. THERE WERE NO BROKEN PIECES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19536408 ↗MalfunctionFeb 12, 2024Mechanical Jam; Mechanical Jam
ADDITIONAL INFORMATION WAS RECEIVED. A. DID THE EVENT OCCUR, DURING THE SURGERY? IF YES, WAS THERE A SURGICAL DELAY? WHAT IS THE DURATION OF THE DELAY? THIS EVENT DID OCCUR, DURING A SURGERY. HOWEVER, I AM UNSURE WHICH SURGERY IT OCCURRED, DURING. IT WAS DIAGNOSED, DURING A ROUTINE INSPECTION OF INSTRUMENTS. I DO NOT KNOW THE LENGTH OF THE DELAY. LIKELY, 30 SECONDS OR LESS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18684540 ↗MalfunctionMay 24, 2023Device-Device Incompatibility; No Apparent Adverse Event; Device-Device Incompatibility; No Apparent Adverse Event
ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS NO SURGICAL DELAY. THE PROCEDURE COMPLETED. ONE PIN WAS USED INSTEAD OF TWO AND THE CUT WAS COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16994489 ↗MalfunctionMay 5, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE PIN WOULD NOT ADVANCE THROUGH THE CUTTING GUIDE AND BROKE IN THE GUIDE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16876383 ↗MalfunctionMar 29, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE PIN IS STUCK IN CUTTING GUIDE. DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16637583 ↗MalfunctionJun 27, 2022Break; Break
IT WAS REPORTED THAT THE PIN BROKE OFF IN THE PINHOLE OF GUIDE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14831873 ↗MalfunctionSep 16, 2021Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE PIN GOT STUCK IN CUTTING GUIDE WHEN THE SURGEON WAS ATTEMPTING TO REMOVE THE PIN FROM THE GUIDE AFTER MAKING HIS CUT. THE GUIDE WAS ABLE TO BE REMOVED AND THE CASE CONTINUED WITHOUT DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12484551 ↗MalfunctionJul 7, 2021Device-Device Incompatibility; Device-Device Incompatibility
DRILL BIT JAMMED INSIDE CUTTING GUIDE. NO FRAGMENTS GENERATED AND GUIDE STILL USED BUT WILL NEED REPLACING. NO TIME ADDED TO THE CASE. NO PATIENT DETAILS OR X-RAYS AVAILABLE. NO SURGERY DELAY. NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12129597 ↗MalfunctionMay 19, 2021Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE CUT GUIDE HAD A PIN GET STUCK FROM A METAL BURR MOST LIKELY. FIXATION PIN WOULDN¿T COME OUT EASY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11849026 ↗MalfunctionMay 10, 2021Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE DRILL BIT IS STUCK IN RESECTION GUIDE. UNABLE TO REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11796347 ↗MalfunctionSep 29, 2020Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT THE PIN WAS STUCK IN THE GUIDE HOLE. THE POLY TRIAL IS CUT AND GOUGED.
Patient problems: No Code Available; No Consequences Or Impact To Patient
MAUDE report 10600610 ↗MalfunctionSep 11, 2020Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE PINS COULD NOT BE INSERTED THROUGH THE RIGHT CUT GUIDE TO FIXATE GUIDE TO HUMERUS.
Patient problems: No Code Available; No Consequences Or Impact To Patient
MAUDE report 10524451 ↗MalfunctionMar 26, 2020Material Deformation; Material Deformation
IT WAS REPORTED THAT THE RIGHT RESECTION GUIDE PIN HOLE WOULD NOT ALLOW A 3.2 FIXATION PIN THROUGH DUE TO EITHER A METAL SPUR OR SOME OTHER REASON. A SURGICAL DELAY OF FIVE MINUTES.
Patient problems: No Code Available; Not Applicable
MAUDE report 9883813 ↗MalfunctionNov 8, 2019Physical Resistance/Sticking; Physical Resistance/Sticking
PIN GETS STUCK IN PIN HOLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9298189 ↗MalfunctionOct 25, 2019Material Deformation; Material Deformation
IT WAS REPORTED THAT UPON CLEANING THEY FOUND THE INSTRUMENT HAVE BURRS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9240523 ↗MalfunctionAug 26, 2019Difficult to Remove; Physical Resistance/Sticking; Difficult to Remove; Physical Resistance/Sticking
IT WAS REPORTED THAT WHILE PRE-DRILLING PIN HOLES THE DRILL BIT GOT STUCK IN THE CUTTING GUIDE AND COULD NOT BE REMOVED. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8932654 ↗MalfunctionFeb 4, 2019Physical Resistance/Sticking; Physical Resistance/Sticking
FIXATION PIN FROM THE GLOBAL UNITE ANATOMICAL PAN BECAME STUCK IN THE HUMERAL CUTTING JIG (RIGHT).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8301074 ↗MalfunctionJan 7, 2019Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE UNITE CUTTING GUIDE ONE OF THE FIXATION HOLES WILL NOT ALLOW THE 3.2 FIXATION PIN THROUGH.
Patient problems: Not Applicable
MAUDE report 8223477 ↗MalfunctionSep 13, 2018Device-Device Incompatibility; Device-Device Incompatibility
FIXATION PIN BECAME LODGED IN CUT GUIDE. PATIENT CONSEQUENCE? :NO.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7872182 ↗MalfunctionSep 12, 2018Device-Device Incompatibility; Appropriate Device Problem Term/Code Not Available; Device-Device Incompatibility; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE REPORTED DRILL COULD NOT DRILL TO FIT THE CUTTING GUIDE TO THE PATIENT¿S BONE DURING ARTIFICIAL SHOULDER JOINT REPLACEMENT SURGERY ON (B)(6) 2018. ALSO, THE DRILL COULD NOT BE DETACHED FROM THE CUTTING GUIDE. THE SURGERY WAS FINISHED WITHOUT ANY OTHER PROBLEM ALTHOUGH IT WAS NOT REPORTED HOW THE SURGERY WAS COMPLETED. IT WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED. THERE WAS LESS THAN 30MIN. SURGICAL DELAY AND NO HARM TO THE PATIENT.
Patient problems: No Code Available
MAUDE report 7869065 ↗MalfunctionSep 11, 2018Difficult to Remove; Difficult to Remove
THE REPORTED DEVICE WAS USED FOR THE DRILLING WITH 3.2MM DRILL (P/N AND LOT NUMBER WERE UNKNOWN) DURING THE SURGERY (DATE OF THE SURGERY WAS UNKNOWN). IT WAS REPORTED THAT THE DRILL WAS STUCK WITH REPORTED CUTTING GUIDE, SO THAT THE DRILL COULD NOT BE COME OFF. THE SURGEON REMOVED THE CUTTING GUIDE TOGETHER WITH STUCK DRILL TO COMPLETE THE SURGERY. IT WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED. THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7863864 ↗MalfunctionAug 13, 2018Difficult to Remove; Difficult to Remove
FIXATION PIN BECAME LODGED IN ANATOMIC RESECTION GUIDE. NO USER ERROR, UNABLE TO ADVANCE OR BACK UP PIN. SURGEON HAD TO CUT PIN IN ORDER TO CONTINUE USING CUT GUIDE. PATIENT CONSEQUENCE? :NO. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? : YES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7776219 ↗MalfunctionMar 7, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THERE WAS A SMALL BUR IN THE FIRST HOLE OF THE CUTTING GUIDE AND THE PIN CANNOT PASSED THROUGH. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7319921 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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