EVOS 71174932Recalls & reported problems
Smith & Nephew, Inc. · FIXED HANDLE T8 SCREW DRIVER · Class 1
All models of EVOS (190)
Data updated Oct 16, 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 00885556387894), received between Feb 17, 2021 and Jul 2, 2025 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Break” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
- Material Fragmentation1
- Naturally Worn1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 2, 2025Break; Break
IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, ONE (1) FIXED HANDLE T8 SCREW DRIVER BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22391567 ↗MalfunctionOct 4, 2022Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT A CHIP IN THE HEAD OF A FIXED HANDLE T8 SCREW DRIVER WAS FOUND AND PRODUCT WAS REJECTED. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15538269 ↗InjurySep 24, 2021Break; Break
IT WAS REPORTED DURING A TRAUMA PROCEDURE, THAT THE TIP OF A FIXED HANDLE T8 SCREW DRIVER SHEARED OFF. ALL PIECES WERE RECOVERED, PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE, NO DELAY REPORTED. NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12529914 ↗MalfunctionFeb 17, 2021Naturally Worn; Naturally Worn
IT WAS REPORTED THAT, SCREWDRIVERS ARE WORN DOWN SO THEY DON'T FIT IN THE SCREWS PROPERLY. THIS WAS NOTICED DURING INSPECTION. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11341065 ↗
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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