Biosteon 234-020-235Recalls & reported problems
Stryker Corporation · 23/28/35MM BIOSTEON SCREW DRIVER · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04546540756350), received between Sep 17, 2018 and Jun 1, 2024 — classified as 1 injury, 6 malfunctions.
The most frequently reported specific device problem is “Break” (6 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
- Break6
- Material Deformation2
- Material Fragmentation1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- No Known Impact Or Consequence To Patient4
- Insufficient Information2
- Foreign Body In Patient1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryJun 1, 2024Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT A SCREWDRIVER BROKE DURING INSTALLATION OF A RESORBABLE LIGAMENTOPLASTY SCREW. A FRAGMENT OF THE SCREWDRIVER GOT STUCK IN THE SCREW THREAD AND THUS REMAINED IN THE PATIENT'S KNEE.
Patient problems: Foreign Body In Patient
MAUDE report 19441831 ↗MalfunctionApr 7, 2021Break; Material Deformation; Material Deformation
IT WAS REPORTED THAT THE DEVICE BROKE DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 11631595 ↗MalfunctionApr 7, 2021Break; Material Deformation; Material Deformation
IT WAS REPORTED THAT THE DEVICE BROKE DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 11631531 ↗MalfunctionSep 28, 2020Break
IT WAS REPORTED THAT THE DEVICE BROKE DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient
MAUDE report 10597302 ↗MalfunctionSep 28, 2020Break
IT WAS REPORTED THAT THE DEVICE BROKE DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient
MAUDE report 10597296 ↗MalfunctionJan 29, 2019Break
IT WAS REPORTED THAT THE SCREW DRIVER BROKE DURING A PROCEDURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8286685 ↗MalfunctionSep 17, 2018Break
IT WAS REPORTED THAT THE BIOSTEON SCREW DRIVER BROKE DURING PROCEDURE. ADDITIONAL INFORMATION CONFIRMED ALL PIECES WERE RETRIEVED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7881204 ↗
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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