ACUFEX 013219DRecalls & reported problems
Smith & Nephew, Inc. · O*REFURB SMALL JOINT GRASPER · Class 1
All models of ACUFEX (86)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556604540), received between Apr 20, 2024 and Apr 20, 2024 — classified as 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 20, 2024Break; Break
IT WAS REPORTED THAT DURING WRIST ARTHROSCOPY, THE SMALL JOINT GRASPER (B)(4) CLAMP BROKE INSIDE THE CAVITY WHEN BEING USED TO REMOVE THE ENTIRE SCREW, WHEN FORCEFULLY USED, THE TIP WAS BROKEN. THE SCREW DID NOT BREAK. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WAS A DELAY GREATER THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19149832 ↗
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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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