EVOS 71177735Recalls & reported problems
Smith & Nephew, Inc. · EVOS LARGE TARGETER 3.7MM DRILL W/AO QC · Class 1
All models of EVOS (190)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556767733), received between Jun 30, 2023 and Jun 12, 2024 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Fracture” (1 report).
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
- Fracture1
- Material Fragmentation1
- Mechanical Jam1
- Separation Failure1
Patient problems
- Device Embedded In Tissue or Plaque1
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 12, 2024Material Fragmentation; Separation Failure; Mechanical Jam; Material Fragmentation; Separation Failure; Mechanical Jam
IT WAS REPORTED THAT, DURING EVOS LARGE PP INTERNAL FIXATION SURGERY, ONE (1) EVOS LARGE TGTR 3.7MM R DRILL GOT JAMMED IN THE DRILL SLEEVE, AFTER PENETRATING THE NEAR CORTEX. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING A S+N BACK-UP DEVICE. AFTER THE PROCEDURE, THE PARTS WERE SEPARATED EXHIBITING SMALL AMOUNTS OF METAL DEBRIS PRESUMABLY COMING FROM THE DRILL FLUTES. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19520912 ↗InjuryJun 30, 2023Fracture; Fracture
IT WAS REPORTED THAT, DURING SURGERY, IT WAS NOTICED THAT, TWO (2) EVOS LARGE TGTR 3.7MM R DRILL BROKE EVEN WITH USE OF TARGETED DRILL GUIDE. DRILL BIT BROKE WHEN WAS BEING USED TO DRILL PILOT HOLE IN DISTAL FEMUR OF PATIENT. PATIENT RECEIVED A RETRO NAIL SIZE 13X22 AND A 14HOLE PERI PROS DISTAL FEMUR PLATE. ONLY ONE OF THE TWO DRILL BITS WAS SUCCESSFULLY RETRIEVED. THE OTHER WAS RETAINED IN THE PATIENT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.
Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient
MAUDE report 17240468 ↗
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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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