ACUFEX 72204050Recalls & reported problems
Smith & Nephew, Inc. · ACUFEX TRUNAV RETROGRADE DRILL 12 MM · Class 1
All models of ACUFEX (86)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885554037791), received between Aug 21, 2020 and Aug 30, 2022 — classified as 2 injuries, 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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Break1
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryAug 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON LITERATURE REVIEW "CLINICAL OUTCOMES OF THE ACUFEX TRUNAV RETROCUTTER DRILL FOR TUNNEL CREATION FOR ACL RECONSTRUCTION", AFTER AN ACL RECONSTRUCTION PROCEDURE, WHERE A TRUNAV DRILL WAS USED TO CREATE THE FITTED BONE TUNNELS, 4 PATIENTS REQUIRED A REVISION SURGERY FOR A MENISCAL DEBRIDEMENT AND 1 OTHER PATIENT REQUIRED A REVISION SURGERY FOR A MENISCAL REPAIR. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15324842 ↗MalfunctionDec 13, 2021Break; Break
IT WAS REPORTED THAT, DURING SURGERY, AN ACUFEX TRUNAV RETROGRADE DRILL WAS USED, THE CUTTER BROKE INSIDE THE TUNNEL. ALL THE PIECES WERE REMOVED USING SUCTION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12985094 ↗InjuryAug 21, 2020Material Separation; Material Separation
IT WAS REPORTED THAT DURING ARTHROSCOPY PROCEDURE, THE PRODUCT BROKE INSIDE THE PATIENT. NO DELAY AND A BACK UP WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Information
MAUDE report 10439296 ↗
Other BIT, SURGICAL devices
- Tornier Perform MWJ127Tornier, Inc. · BIT, SURGICAL114 reports
- NA 310.534Synthes GmbH · BIT, SURGICAL64 reports
- NA 4200355042Stryker Corporation · BIT, SURGICAL34 reports
- ACUFEX 72204044Smith & Nephew, Inc. · BIT, SURGICAL25 reports
- NA 03.168.011Synthes GmbH · BIT, SURGICAL20 reports
- ACUFEX 72204042Smith & Nephew, Inc. · BIT, SURGICAL19 reports
- ACUFEX 72204046Smith & Nephew, Inc. · BIT, SURGICAL16 reports
- ACUFEX 72204045Smith & Nephew, Inc. · BIT, SURGICAL14 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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