ACUMED 80-4244Recalls & reported problems
Acumed LLC · T8 Stick Fit Hexalobe Driver · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10806378126598), received between Feb 16, 2026 and May 21, 2026 — classified as 4 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break3
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 21, 2026Break
IT WAS REPORTED: " A DRIVER TIP BROKE DURING A CASE. DOCTOR HAD EXPLAINED TO THE REP HE MAY HAVE OVER TORQUED THE SCREW DUE TO THE SCREW HEAD NOT SEATING IN PLATE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25249876 ↗MalfunctionApr 3, 2026Break
IT WAS REPORTED: 1 X T8 DRIVER TIP BROKE DURING FINIAL TIGHTENING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24781957 ↗MalfunctionMar 13, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED: BILATERAL DISTAL RADIUS FRACTURES THAT EXTEND INTO THE PROXIMAL RADIUS. PT. IS A RATHER LARGE MALE. WE USED A WIDE RIGHT PLATE WITH THE MEDIUM EXTENSION PLATE AND A STANDARD LONG LEFT PLATE WITH THE NEUTRAL EXTENSION. IN BOTH THE LEFT AND RIGHT, AS DR. (B)(6) WAS FINISHING IS PROXIMAL FIXATION, HE WAS FULLY SEATING HIS SCREWS AND THE SCREWS BROKE. THEY BROKE RIGHT AT THE NECK OF THE SCREW WHERE THE HEAD AND BODY MEET. HE DID NOT USE AN EXCESSIVE AMOUNT OF TORQUE AS HE WAS FULLY SEATING THESE SCREWS. I BELIEVE HE BROKE THE 2.7 X 16 IN THE RIGHT RADIUS AND 2.7 X 14 IN THE LEFT RADIUS BUT I'M NOT 100% ON THAT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24594485 ↗MalfunctionFeb 16, 2026Break
IT WAS REORTED THAT THE DRIVER BROKE DURING USE. THE PROCEDURE WAS COMPLETED USING ANOTHER DRIVER. THERE WAS NO REPORTED DELAY OR ADVERSE CONSEQUENCE TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24351742 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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