Arsenal 87134Recalls & reported problems
Alphatec Spine, Inc. · T27 SET SCREW DRIVER, STOP · Class 1
All models of Arsenal (18)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This is an Alphatec Spine set screwdriver, a surgical instrument used to tighten and stop bone screw during spine procedures. The 36 reports mostly describe the tool tip breaking, twisting, or stripping, and parts separating from it. Three reports mention injuries and no deaths were reported. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 36
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 00840967197906), received between Feb 27, 2020 and Apr 27, 2026 — classified as 3 injuries, 33 malfunctions.
The most frequently reported specific device problem is “Break” (32 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
- Break32
- Material Separation16
- Fracture4
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions31
- Insufficient Information3
- Device Embedded In Tissue or Plaque1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 36 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 27, 2026Fracture
IT WAS REPORTED THE DRIVER TIP WAS FOUND TO BE TWISTED WITH A PORTION OF THE DISTAL TIP MISSING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25005435 ↗MalfunctionMar 5, 2026Break; Material Separation
IT WAS REPORTED THAT THE DRIVER IS NOT WORKING PROPERLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24523679 ↗MalfunctionDec 30, 2025Break; Material Separation; Break; Material Separation
IT WAS REPORTED THAT THE DRIVER IS DAMAGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23924581 ↗MalfunctionDec 15, 2025Break; Material Separation; Break; Material Separation
IT WAS REPORTED THAT THE TIP OF THE DRIVER IS STRIPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23807230 ↗MalfunctionDec 1, 2025Break; Material Separation; Break; Material Separation
IT WAS REPORTED THAT THE DRIVER HAS A BROKEN TIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23682535 ↗MalfunctionDec 1, 2025Break; Material Separation; Break; Material Separation
IT WAS REPORTED THAT THE DRIVER HAS A BROKEN TIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23682293 ↗MalfunctionDec 1, 2025Break; Material Separation; Break; Material Separation
IT WAS REPORTED THAT THE DRIVER HAS A BROKEN TIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23681889 ↗MalfunctionNov 4, 2025Break; Material Separation; Break; Material Separation
IT WAS REPORTED THAT THE DRIVER WAS NOT FUNCTIONING PROPERLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23466714 ↗MalfunctionOct 15, 2025Break; Material Separation; Break; Material Separation
IT WAS REPORTED THAT THE TIP OF THE DRIVER BROKE OFF DURING A CASE. THE TIP WAS RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23292722 ↗MalfunctionAug 19, 2025Break; Break
IT WAS REPORTED THAT THE TIP OF THE DRIVER BROKE OFF DURING A CASE. THE TIP WAS NOT LEFT IN THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22843783 ↗MalfunctionJun 18, 2025Fracture; Fracture
IT WAS REPORTED THAT THE DRIVER BROKE WHILE TAKING OUT A SCREW FOR AN UNKNOWN REASON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22287600 ↗MalfunctionJun 11, 2025Break; Material Separation; Break; Material Separation
IT WAS REPORTED THAT THE TIP OF THE DRIVER BROKE OFF IN A SET SCREW WHILE FINAL TIGHTENING DURING A CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22187246 ↗MalfunctionApr 16, 2025Break; Material Separation; Break; Material Separation
IT WAS REPORTED THAT THE TIP OF THE DRIVER IS CHIPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21852771 ↗MalfunctionMar 25, 2025Break; Material Separation; Break; Material Separation
IT WAS REPORTED THAT THE TIP OF THE DRIVER BROKE OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21688570 ↗MalfunctionMar 13, 2025Break; Material Separation; Break; Material Separation
IT WAS REPORTED THAT THE DRIVER TWISTED WHILE FINAL TIGHTENING A SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21596969 ↗MalfunctionMar 13, 2025Break; Material Separation; Break; Material Separation
IT WAS REPORTED THE TIP OF THE DRIVER BROKE OFF WHILE TRYING TO REMOVE PREVIOUSLY IMPLANTED HARDWARE. THE TIP WAS RECOVERED AND DISPOSED OF AT THE HOSPITAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21596936 ↗MalfunctionMar 6, 2025Break; Material Separation; Break; Material Separation
IT WAS REPORTED THAT THE TIP OF THE DRIVER BROKE DURING PROVISIONAL TIGHTENING OF A SCREW DURING A CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21542455 ↗MalfunctionJan 9, 2025Break; Material Separation; Break; Material Separation
IT WAS REPORTED THAT THE TIP OF THE DRIVER BROKE OFF DURING A CASE. THE TIP WAS REMOVED FROM THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21119006 ↗MalfunctionNov 19, 2024Break; Material Separation; Break; Material Separation
IT WAS REPORTED THAT THE DRIVER IS BROKEN.
Patient problems: Insufficient Information
MAUDE report 20727530 ↗MalfunctionOct 30, 2024Break; Break
IT WAS REPORTED THAT THE TIP OF THE DRIVER IS TWISTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20567785 ↗MalfunctionOct 17, 2024Break; Break
IT WAS REPORTED THAT THE DRIVER BROKE DURING REMOVAL OF A SCREW. THIS IS REPORT 2 OF 3.
Patient problems: Insufficient Information
MAUDE report 20477216 ↗MalfunctionSep 11, 2024Break; Break
IT WAS REPORTED THAT THE TIP OF THE DRIVER BROKE OFF DURING A CASE. THE TIP WAS REMOVED FROM THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20193018 ↗MalfunctionJul 25, 2024Break; Break
IT WAS REPORTED THAT THE TIP OF THE DRIVER BROKE OFF DURING A CASE. THE TIP WAS REMOVED FROM THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19833661 ↗MalfunctionJun 7, 2024Break; Break
IT WAS REPORTED THAT THE TIP OF THE DRIVER BROKE OFF DURING A CASE. THE TIP WAS RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19484115 ↗MalfunctionMay 2, 2024Break; Break
IT WAS REPORTED THE TIP OF THE DRIVER BROKE WHILE REMOVING HARDWARE DURING A REVISION SURGERY. THE TIP WAS RETRIEVED.
Patient problems: Insufficient Information
MAUDE report 19234845 ↗
Other SCREWDRIVER devices
- DELTA XTEND 2307-92-003Depuy (Ireland) · SCREWDRIVER751 reports
- EXPEDIUM 279712400Medos International Sàrl · SCREWDRIVER551 reports
- NA 314.467Synthes GmbH · SCREWDRIVER498 reports
- N/A 5584111Medtronic Sofamor Danek, Inc. · SCREWDRIVER492 reports
- QUICKSET 2274-47-000Depuy (Ireland) · SCREWDRIVER487 reports
- NA 03.130.010Synthes GmbH · SCREWDRIVER1 recall422 reports
- QUICKSET 2274-63-000Depuy (Ireland) · SCREWDRIVER404 reports
- EVOS 71175072Smith & Nephew, Inc. · SCREWDRIVER336 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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