Biosteon 234-020-234Recalls & reported problems
Stryker Corporation · 23MM BIOSTEON SCREW DRIVER · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613154111190), received between May 30, 2018 and Jun 26, 2026 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Break” (4 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
- Break4
- Fracture2
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information1
- No Information1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 26, 2026Break; Fracture
IT WAS REPORTED THAT THE SCREWDRIVER BROKE DURING PROCEDURE. ALL BROKEN PIECES WERE REMOVED FROM THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25638793 ↗MalfunctionMay 17, 2024Break; Fracture; Break; Fracture
IT WAS REPORTED THAT THE TIP OF THE DEVICE BROKE DURING THE PROCEDURE. THE TIP WAS ABLE TO BE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19347142 ↗MalfunctionNov 18, 2021Break
IT WAS REPORTED THAT THE TIP OF THE DEVICE BROKE DURING THE PROCEDURE. THE TIP WAS RETRIEVED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 12838154 ↗InjuryMay 30, 2018Break
IT WAS REPORTED THE SCREW DRIVER BROKE INSIDE PATIENT.
Patient problems: No Information
MAUDE report 7555472 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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