ACUFEX 012705Recalls & reported problems
Smith & Nephew, Inc. · RASP CONVEX · Class 2
All models of ACUFEX (86)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010080653), received between Jun 23, 2019 and Dec 28, 2023 — classified as 2 malfunctions.
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
- Material Separation1
Patient problems
- 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.
MalfunctionDec 28, 2023Break; Break
IT WAS REPORTED THAT DURING ACL RECONSTRUCTION SURGERY, THE RASP CONVEX BROKE WHEN THE EDGES OF THE TIBIAL TUNNEL WERE SCRAPED. THE BROKEN PIECE WAS REMOVED FROM THE TUNNEL. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18414017 ↗MalfunctionJun 23, 2019Material Separation; Material Separation
IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY, THE DEVICE BROKE, ALL PIECES WERE REMOVED. IT IS UNKNOWN IF THERE WAS A BACKUP DEVICE AVAILABLE TO COMPLETE THE SURGERY. DELAY OR PATIENT INJURIES WERE NOT REPORTED.
Patient problems: Foreign Body In Patient
MAUDE report 8725689 ↗
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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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