LARGE CANNULATED SCREWS 71177158Recalls & reported problems
Smith & Nephew, Inc. · 4.7MM HEXDRIVER SHAFT WITH QUICK CONNECT · Class 1
All models of LARGE CANNULATED SCREWS (21)
Data updated Oct 18, 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 03596010601582), received between Oct 21, 2020 and Apr 5, 2022 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Break” (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 18, 2026.
Most reported problems
Device problems
- Break1
- Material Deformation1
- Unclear Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Injury1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 5, 2022Break; Break
IT WAS REPORTED THAT, DURING SURGERY, A 4.7MM HEXDRIVER SHAFT W/ QC BROKE. THE PROCEDURE WAS COMPLETED, WITH DELAY LESS THAN 30 MIN, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14018461 ↗InjuryOct 21, 2020Material Deformation; Unclear Information; Material Deformation; Unclear Information
IT WAS REPORTED THAT THE PATIENT WAS INJURED BUT THE SURGEON SAYS THAT THE PATIENT SEEMS STABLE. NO FURTHER INFORMATION IS AVAILABLE AT THE MOMENT.
Patient problems: Injury; No Clinical Signs, Symptoms or Conditions
MAUDE report 10715307 ↗
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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