GLOBAL ADVANTAGE 2128-61-011Recalls & reported problems
Depuy (Ireland) · GLOBAL ADVANTAGE ANTI ROTATION PIN GRASPER · Class 1
- 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 10603295089339), received between Jun 22, 2018 and Aug 11, 2021 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Break” (6 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Break6
Patient problems
- No Consequences Or Impact To Patient5
- 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.
MalfunctionAug 11, 2021Break; Break
IT WAS REPORTED THAT THE INSTRUMENT WAS BROKEN AND UNUSABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12307272 ↗MalfunctionOct 12, 2020Break; Break
IT WAS REPORTED THAT ONE OF THE ENDS OF THE GLOBAL ADV ANTI-ROTATION PEG GRASPER BROKE OFF DURING REMOVING ONE OF THE PEGS. THE PIECE WAS FOUND, AND DISPOSED OF. NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10666755 ↗MalfunctionMar 20, 2019Break; Break
IT WAS REPORTED THAT THE PEG INSERTER BROKE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8437167 ↗MalfunctionMar 18, 2019Break; Break
IT WAS REPORTED THAT THE GLOBAL ADVANTAGE CENTRAL DRILL FOR GLENOID AND GLOBAL ADVANTAGE DEROTATIONAL PEG CLAMP BROKE. NO SURGICAL DELAY HAPPEN.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8429137 ↗MalfunctionJul 19, 2018Break; Break
IT WAS REPORTED THAT GRASPER BROKE DURING SURGERY. ALL PIECES WERE RETRIEVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7704533 ↗MalfunctionJun 22, 2018Break; Break
IT WAS REPORTED THAT TIP OF APG PEG HOLDER IS BROKEN OFF. ALL PIECES ARE ACCOUNTED FOR.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7629740 ↗
Other IMPACTOR devices
- PINNACLE 2217-50-041Depuy (Ireland) · IMPACTOR4,295 reports
- ATTUNE 2544-01-006Depuy (Ireland) · IMPACTOR1 recall2,539 reports
- ATTUNE 2544-01-003Depuy (Ireland) · IMPACTOR1 recall1,498 reports
- ATTUNE 2544-01-017Depuy (Ireland) · IMPACTOR1 recall1,456 reports
- ATTUNE 2544-01-004Depuy (Ireland) · IMPACTOR1 recall875 reports
- DURALOC 2360-71-000Depuy Orthopaedics, Inc. · IMPACTOR716 reports
- SPECIALIST 2581-11-000Depuy (Ireland) · IMPACTOR704 reports
- INHANCE 6205-10-103Depuy (Ireland) · IMPACTOR337 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.