ACUMED 80-4149Recalls & reported problems
Acumed LLC · T6 Cannulated Hexalobe Driver · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10806378121609), received between Mar 20, 2026 and Mar 20, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Fragmentation” (1 report).
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 Fragmentation1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 20, 2026Material Fragmentation
IT WAS REPORTED VIA A TEXT GENERATED VOICEMAIL: "HEY, AND REMIND NAME IS (B)(6). I AM OUT IN (B)(6) WITH (B)(6). WE HAVE BROKEN 2 OF THE CANNED NANO DRIVER TIPS, 80414 901 BROKE OFF TODAY AND AFFECTED THE CASE. HE WAS DOING A PERK SKATEBOARD, A 2 SCREW SKATEBOARD, AND BROKE IT ON THE SECOND SCREW, AND HAD TO OPEN IT. SO I NEED TO GET AN R TO SEND BACK THIS DRIVER TIP SO YOU GUYS CAN LOOK AT IT. AND I THINK I WILL HAVE A CARD. I WILL CALL THE DR. SO JUST SO YOU KNOW, I NEED TO FILE A REGISTER A COMPLAINT ON A BROKEN DRIVER SLIP AGAIN, THE PART NUMBERS 804149 AND GET AN R TO SEND THAT DRIVER TIP BACK (B)(6). THANKS, (B)(6)."
Patient problems: Insufficient Information
MAUDE report 24653785 ↗
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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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