ACUFEX 72203450Recalls & reported problems
Smith & Nephew, Inc. · ACUFEX PINPOINT 4-POINT BULLET, 6.5 INCH · 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885554026917), received between May 18, 2020 and May 18, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Illegible Information” (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.
Most reported problems
Device problems
- Illegible Information1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 18, 2020Illegible Information; Illegible Information
IT WAS REPORTED THAT DURING ACL REPAIR WHEN USING THE INSTRUMENT TO MAKE THE TIBIA TUNNEL, IT WAS FOUND THAT THE NUMBERS COULD NOT BE SEEN, THEY ARE BLURRED. NO SIGNIFICANT DELAY AND THE PROCEDURE WAS FINISHED WITH THE SAME DEVICE. NO OTHER COMPLICATION WERE REPORTED. RESULTS OF INVESTIGATION SHOWED THAT BOTH PIN POINT BULLETS HAD BROKEN DISTAL TIPS. THIS MEANS THAT THE EVENT MAY NECESSITATE MEDICAL OR SURGICAL INTERVENTION, SUCH AS RETRIEVAL OF DEVICE FRAGMENTS FROM THE OPERATIVE FIELD WHICH MAKES IT A REPORTABLE EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10068405 ↗
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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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