Tools - WFS CUTRWIR-1.1Recalls & reported problems
Trimed, INC. · Wire Cutter, 1.1mm · Class 1
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 00842188113697), received between Jul 8, 2025 and Jul 8, 2025 — 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
- Oversedation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 8, 2025Break; Break
A SALES REP REPORTED ON 10JUN2025 THAT CUTRWIR-1.1 FROM THE TRIMED WRIST FIXATION SYSTEM BROKE DURING SURGERY. SURGEON REPORTED THIS ISSUE CAUSED A 40 MINUTE DELAY UNTIL THEY FOUND A REPLACEMENT. GIVEN THIS SYSTEM IS USED ONLY ONCE A MONTH, THIS ISSUE WAS NOT DUE TO HEAVY USAGE. IT WAS CONFIRMED THAT THE DEVICE DID NOT COME INTO CONTACT WITH THE PATIENT AND NO BROKEN PARTS OF THE DEVICE WERE LEFT IN THE PATIENT.
Patient problems: Oversedation
MAUDE report 22438775 ↗
Other CUTTER, WIRE devices
- NA 03.607.513Synthes GmbH · CUTTER, WIRE35 reports
- NA 03.221.006Synthes GmbH · CUTTER, WIRE34 reports
- NA 388.72Synthes GmbH · CUTTER, WIRE29 reports
- NA 03.221.008Synthes GmbH · CUTTER, WIRE11 reports
- NA 391.93Synthes GmbH · CUTTER, WIRE9 reports
- NA 391.906Synthes GmbH · CUTTER, WIRE8 reports
- NA 391.771Synthes GmbH · CUTTER, WIRE8 reports
- NA 391.905Synthes GmbH · CUTTER, WIRE7 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.
How reports and recalls are matched · Editorial policy · Report an error on this page