CHISEL 7209645Recalls & reported problems
Smith & Nephew, Inc. · CHISEL MICRO VULCAN ANGLED INTEGRATED · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010470461), received between Dec 11, 2017 and Jan 18, 2021 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Device Markings/Labelling Problem” (3 reports).
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
- Device Markings/Labelling Problem3
- Failure to Deliver Energy1
Patient problems
- No Known Impact Or Consequence To Patient3
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 18, 2021Failure to Deliver Energy; Failure to Deliver Energy
IT WAS REPORTED THAT DURING SURGERY, UPON ACTIVATION BY FOOT PEDAL, ONLY SOUND WAS HEARD FROM THE CONSOLE. NO RF WAS SEEN TRANSFERRED TO TARGETED TISSUE FROM THE CHISEL MICRO VULCAN ANGLED INTEGRATED. NOTHING HAPPEN EXCEPT FOR THE SOUND OF ¿ACTIVATION¿ ON CONSOLE. SALINE WAS CHECKED AND CABLES WERE REPLUG IN TO TRY AGAIN, BUT SAME RESULT AS PREVIOUS. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO SIGNIFICANT DELAY OR PATIENT INJURIES. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11183939 ↗MalfunctionDec 11, 2017Device Markings/Labelling Problem
IT WAS REPORTED THAT THE PRODUCT WAS MISLABELED. THE CURVED MICRO LIGAMENT CHISEL WAS IN THE ANGLED CHISEL BOX. NO PATIENT INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7104691 ↗MalfunctionDec 11, 2017Device Markings/Labelling Problem
IT WAS REPORTED THAT THE PRODUCT WAS MISLABELED. THE CURVED MICRO LIGAMENT CHISEL WAS IN THE ANGLED CHISEL BOX. NO PATIENT INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7104690 ↗MalfunctionDec 11, 2017Device Markings/Labelling Problem
IT WAS REPORTED THAT THE PRODUCT WAS MISLABELED. THE CURVED MICRO LIGAMENT CHISEL WAS IN THE ANGLED CHISEL BOX. NO PATIENT INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7104682 ↗
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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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