GLOBAL ADVANTAGE 2128-61-012Recalls & reported problems
Depuy (Ireland) · GLOBAL ADVANTAGE STRAIGHT DRILL DRIVER W/CELCON SLEEVE · Class 1
All models of GLOBAL ADVANTAGE (28)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295089346), received between Oct 26, 2018 and Jan 14, 2025 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Break” (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.
Reports received per month
Most reported problems
Device problems
- Break3
- Mechanical Jam3
- Material Twisted/Bent1
Patient problems
- No Consequences Or Impact To Patient3
- No Code Available2
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 14, 2025Break; Break
IT WAS REPORTED THAT THE PERIPHERAL DRILL BIT BROKE OFF IN THE DRIVER SHAFT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21150013 ↗MalfunctionOct 14, 2020Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT DURING A TOTAL SHOULDER REPLACEMENT, THE ANTERIOR PEG PERIPHERAL BIT ((B)(4)) BROKE OFF MIDWAY DOWN THE THREADS OF THE DRILL BIT, TWICE/ A DIFFERENT BITS. THE BREAK LEFT HALF OF THE THREADS IN THE GLOBAL ADVANTAGE AT DRILL DRIVER. WE CHANGED APG INSTRUMENTS. A SURGICAL DELAY OF FIVE MINUTES.
Patient problems: No Code Available
MAUDE report 10676961 ↗MalfunctionOct 14, 2020Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT DURING A TOTAL SHOULDER REPLACEMENT, THE ANTERIOR PEG PERIPHERAL BIT ((B)(4)) BROKE OFF MIDWAY DOWN THE THREADS OF THE DRILL BIT, TWICE/ A DIFFERENT BITS. THE BREAK LEFT HALF OF THE THREADS IN THE GLOBAL ADVANTAGE AT DRILL DRIVER. WE CHANGED APG INSTRUMENTS. A SURGICAL DELAY OF FIVE MINUTES.
Patient problems: No Code Available
MAUDE report 10676960 ↗MalfunctionAug 27, 2020Break; Break
IT WAS REPORTED THAT THE INSTRUMENT FROM OUT OF OFFICE SET HAS A BROKEN TIP. NO SURGERY AFFECTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10462547 ↗MalfunctionJul 15, 2020Material Twisted/Bent; Mechanical Jam; Material Twisted/Bent; Mechanical Jam
PERIPHERAL DRILL BIT BROKE AND THREADED PART REMAINED IN THE DRILL SHAFT. ALL PIECES WERE RETRIEVED AND THERE WAS NO DELAY IN SURGERY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10278217 ↗MalfunctionOct 26, 2018Break; Break
Other DRIVER, PROSTHESIS devices
- ATTUNE 2544-01-005Depuy (Ireland) · DRIVER, PROSTHESIS1,383 reports
- EXPEDIUM VERSE 299704230Medos International Sàrl · DRIVER, PROSTHESIS875 reports
- NA 9200-10-029Depuy (Ireland) · DRIVER, PROSTHESIS745 reports
- MOSS 279712600Depuy Spine, LLC · DRIVER, PROSTHESIS706 reports
- NA 2598-07-440Depuy (Ireland) · DRIVER, PROSTHESIS665 reports
- NA 2598-07-570Depuy (Ireland) · DRIVER, PROSTHESIS505 reports
- VIPER 286745550Depuy Spine, LLC · DRIVER, PROSTHESIS263 reports
- SUMMIT 2570-05-100Depuy (Ireland) · DRIVER, PROSTHESIS225 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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