ACUMED HT-0915Recalls & reported problems
Acumed LLC · 1.5mm Cann. Quick Release Driver Tip · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10806378070198), received between Feb 12, 2026 and Apr 28, 2026 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Material Fragmentation” (2 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
- Material Fragmentation2
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 28, 2026Material Fragmentation
IT WAS REPORTED: AT2 MICRO DRIVER BROKE OFF IN SCREW HEAD. PULLED BROKEN PART OUT AND USED A SECOND DRIVER. 15MINS DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25022927 ↗InjuryFeb 16, 2026Break
IT WAS REORTED THAT A MICRO DRIVER TIP BROKE OFF IN THE SCREW HEAD WHEN PUTTING IN SCREW. THE PIECE WAS EXTRACTED AND ANOTHER DRIVER WAS USED. A REPORTED DELAY OF 20 MINUTES WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24351644 ↗InjuryFeb 12, 2026Material Fragmentation
IT WAS REPORTED THAT THE SURGEON NOTICED THE BROKEN DRIVER ON THE POSTOPERATIVE X-RAY. THE SURGERY TO REMOVE THE BROKEN DRIVER TIP WAS PERFORMED 8 DAYS LATER.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 24328625 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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