GLOBAL ADVANTAGE 2128-61-070Recalls & reported problems
Depuy (Ireland) · GLOBAL ADVANTAGE T-HANDLE · 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 T-handle is a hand tool used by orthopedic surgeons to drive reamers and other implants. The 58 reports mostly describe the handle wearing out or breaking — cracking, the rubber grip or coating peeling off, and the ratchet mechanism jamming or failing to lock onto the reamer, sometimes forcing the case to be delayed or a backup handle used. Reports describe 1 injury and no deaths, and 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
- 59
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 59 adverse event reports that list this exact device (DI 10603295089728), received between Jul 21, 2017 and Sep 21, 2026 — classified as 1 injury, 58 malfunctions.
The most frequently reported specific device problem is “Crack” (14 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
- Crack14
- Break13
- Naturally Worn13
- Peeled/Delaminated9
- Mechanical Jam5
- Appropriate Device Problem Term/Code Not Available4
- Scratched Material4
- Detachment of Device or Device Component3
Patient problems
- No Clinical Signs, Symptoms or Conditions29
- No Consequences Or Impact To Patient25
- No Information3
- Insufficient Information1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 59 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 21, 2026Break
It was reported that the T-HANDLE instrument was worn out and was flaking. ¿CSP¿ deemed it a bioburden hazard. All available information has been disclosed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50840499 ↗MalfunctionJun 5, 2026Mechanical Jam
IT WAS REPORTED THAT IMPACTED PRODUCT WAS NOT RATCHETING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25412746 ↗MalfunctionNov 19, 2024Break; Break
IT WAS REPORTED THAT THE SALES REPRESENTATIVE NOTICED THAT THE RUBBER ON TOP OF THE HANDLE WAS SHREDDING. IT WAS REMOVED FROM USE. THE EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20724708 ↗MalfunctionJun 12, 2024Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT THE T HANDLE WAS NOT WORKING PROPERLY DURING CASE. ITEM WAS NOT RATCHETING. USED BACK UP SET T HANDLE. ONLY SLIGHT DELAY TO CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19519190 ↗MalfunctionApr 17, 2024Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT FORWARD WRATCHET WAS NOT WORKING.
Patient problems: Insufficient Information
MAUDE report 19123935 ↗MalfunctionMar 8, 2024Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility
IT WAS REPORTED THAT THE RATCHET HANDLE WOULD NOT LOCK ONTO STRAIGHT REAMER. IT APPEARS ONE OF THE BALL BEARINGS INSIDE THE HANDLE IS MISSING. THIS WAS OBSERVED WHILE SETTING UP THE CASE SO NO ISSUES TO PATIENT. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18869456 ↗MalfunctionFeb 16, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE RUBBER WAS COMING OFF THE T-HANDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18721121 ↗MalfunctionFeb 16, 2024Naturally Worn; Naturally Worn
IT WAS REPORTED THAT T HANDLE RUBBER HAS TORN OFF. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18720103 ↗MalfunctionDec 22, 2023Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE TOP COATING OF THE HANDLE WAS FLAKING. NOTHING WAS LEFT IN THE PATIENT AND THE SURGERY WAS NOT DELAYED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18388537 ↗MalfunctionDec 22, 2023Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE TOP COATING OF THE HANDLE WAS FLAKING. NOTHING WAS LEFT IN THE PATIENT AND THE SURGERY WAS NOT DELAYED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18382350 ↗InjuryJul 13, 2023Naturally Worn; Unintended Movement; Naturally Worn; Unintended Movement
ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE REAMER JUST SPINS AS OPPOSED TO FORWARD AND BACKWARD REAMING ACTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17315124 ↗MalfunctionJul 5, 2023Naturally Worn; Naturally Worn
IT WAS REPORTED THAT STANDARD HUDSON T HANDLE IS QUITE WORN ON THE PLASTIC / RUBBER AND IT IS THROUGH TO THE METAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17258887 ↗MalfunctionJun 5, 2023Crack; Contamination /Decontamination Problem; Crack; Contamination /Decontamination Problem
IT WAS REPORTED THAT THE DEVICE IS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17063815 ↗MalfunctionMay 31, 2023Naturally Worn; Naturally Worn
DEVICE WAS REPORTED FOR GENERAL WEAR AND TEAR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17032440 ↗MalfunctionMay 1, 2023Crack; Crack
IT WAS REPORTED THAT THE PLASTIC IS CRACKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16843028 ↗MalfunctionDec 27, 2022Break; Break
CSSD NOTIFIED REP THAT THERE IS A SMALL SPLIT PRESENT ON THE T HANDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16053036 ↗MalfunctionDec 15, 2022Break; Break
IT WAS REPORTED THAT THE BLUE SCREW DRIVER IS STRIPPED AND WILL NOT HOLD METAGLENE PIN GUIDE. T-HANDLE RUBBER IS TORN AND SPD WILL NOT PROCESS. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15987853 ↗MalfunctionDec 8, 2022Break; Break
T-WRENCH WAS SHIPPED BROKEN. THE SURGERY WAS PERFORMED WITH A BROKEN KEY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15941827 ↗MalfunctionAug 25, 2022Break; Break
IT WAS REPORTED THAT THE HANDLE HAS RUBBER FALLING OFF IT. NOTIFIED BY CSSD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15296886 ↗MalfunctionJun 9, 2022Crack; Contamination /Decontamination Problem; Crack; Contamination /Decontamination Problem
IT WAS REPORTED THAT AFTER THE PANS WENT THROUGH THE WASH, IT WAS NOTIFIED BY SPD THAT THE RUBBER ON THE T-HANDLE WAS RIPPED AND THAT THEY COULD NO LONGER USE IT. THE T-HANDLE IS STILL USEABLE BUT THEY ARE UNABLE TO CLEAN IT AND KEEP IT STERILE. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14647329 ↗MalfunctionApr 26, 2022Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE BLACK RUBBER PEELING OFF HANDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14207313 ↗MalfunctionApr 25, 2022Naturally Worn; Naturally Worn
IT WAS REPORTED THAT BLACK RUBBER PEELING OFF HANDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14194450 ↗MalfunctionApr 25, 2022Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE BLACK RUBBER PEELING OFF ON HANDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14194357 ↗MalfunctionMar 19, 2022Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT THE T-HANDLE HAS FAILED TO RATCHET. COULD NOT SEE THE ISSUE, INTERNAL MECHANISM MUST HAVE FAILED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13823587 ↗MalfunctionDec 3, 2021Break; Break
IT WAS REPORTED THAT THE RATCHETING T-HANDLE RUBBER IS TORN AND IS NOT APPROVED FOR STERILIZATION. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12923511 ↗
Other Orthopedic manual surgical instrument devices
- AML EXCEL 2001-42-000Depuy (Ireland) · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2,009 reports
- NA 03.010.523Synthes GmbH · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,208 reports
- EXPRESSEW 214141Medos International Sàrl · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,166 reports
- N/A 9560524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT866 reports
- INHANCE 6500-11-104Depuy (Ireland) · Orthopedic manual surgical instrument831 reports
- INHANCE 6500-11-102Depuy (Ireland) · Orthopedic manual surgical instrument567 reports
- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
- N/A 9561524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT494 reports
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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