EVOS 71177733Recalls & reported problems
Smith & Nephew, Inc. · EVOS LARGE TARGETER 3.5MM LINEAR HEX DRIVER SHAFT W/AO QC · Class 1
All models of EVOS (190)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556767719), received between May 24, 2023 and Jan 2, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Fracture” (3 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
- Fracture3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 2, 2024Fracture; Fracture
IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION AN EVOS LARGE TGTR 3.5MM LINEAR HEX DRVR QC BROKE OFF IN A LARGE SCREWDRIVER HANDLE WHILE TIGHTENING A SCREW. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. IT IS UNKNOWN IF PIECES FELL INTO THE PATIENT, BUT NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18428777 ↗MalfunctionJul 20, 2023Fracture; Fracture
IT WAS REPORTED THAT DURING A TRAUMA SURGERY, THE EVOS LARGE TGTR 3.5MM LINEAR HEX DRVR QC DEVICE BROKE OFF INSIDE SCREW HEAD WHILE SURGEON PUT A LOCKING SCREW IN ON POWER. THE TIP OF THE SCREW DRIVER WAS EASILY RETRIEVED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17358224 ↗MalfunctionMay 24, 2023Fracture; Fracture
IT WAS REPORTED THAT DURING SURGERY, THE TIP OF THE EVOS LARGE TGTR 3.5MM LINEAR HEX DRVR QC BROKE OFF IN SCREW HEAD WHILE PUTTING A LOCKING SCREW IN ON POWER. SURGEON DID NOT STOP SOON ENOUGH. THE HEAD WAS EASILY PULLED OUT OF THE SCREW HEAD. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16993301 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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