ACUMED 80-4151Recalls & reported problems
Acumed LLC · T8 Cannulated Hexalobe Driver · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10806378121623), received between Oct 27, 2025 and Jun 10, 2026 — classified as 1 injury, 4 malfunctions.
The most frequently reported specific device problem is “Material Fragmentation” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Material Fragmentation3
- Break2
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information2
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 10, 2026Material Fragmentation
IT WAS REPORTED THAT DURING A CASE, TWO SCREWDRIVERS BROKE AND THE RATCHETING HANDLE WAS NOT FUNCTIONING APPROPRIATELY. THE FACILITY ENDED UP DISPOSING THE 2 BROKEN SCREW DRIVERS.
Patient problems: Insufficient Information
MAUDE report 25463747 ↗MalfunctionJun 10, 2026Material Fragmentation
IT WAS REPORTED THAT DURING A CASE, TWO SCREWDRIVERS BROKE AND THE RATCHETING HANDLE WAS NOT FUNCTIONING APPROPRIATELY. THE FACILITY ENDED UP DISPOSING THE 2 BROKEN SCREW DRIVERS.
Patient problems: Insufficient Information
MAUDE report 25463744 ↗InjuryMay 12, 2026Material Fragmentation
IT WAS REPORTED: CASE WAS FOR A SCAPHOID FRACTURE. USED THE ACUTRAK 3 MINI. THE CANNULATED NON STICK DRIVER TIP FOR THE MINI BROKE AT THE TIP DURING INSERTION. IT WAS ABLE TO REMOVED AND DIDN'T CAUSE AN ISSUE. THEY WERE ABLE TO FINISH THE CASE WITH ANOTHER DRIVER TIP. 15 MINUTE DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25155830 ↗MalfunctionNov 11, 2025Break; Break
IT WAS REPORTED THAT THE ACUTRAK 3 MINI DRIVER TIP BROKE OFF IN MINI SCREW PROCEDURE WAS COMPLETED WITHOUT COMPLICATION, TIP WAS ABLE TO BE REMOVED FROM THE SCREW. NO ADVERSE EVENT OR DELAY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23528151 ↗MalfunctionOct 27, 2025Break; Break
IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, A DRILL TIP BROKE DURING FINAL TIGHTENING. NO PART OF DRILL BIT WAS LEFT IN THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23392353 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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