TRIGEN 71631128Recalls & reported problems
Smith & Nephew, Inc. · RULER · Class 1
- 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 03596010419521), received between Apr 21, 2021 and Apr 16, 2022 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Break3
- Corroded1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 16, 2022Corroded; Corroded
IT WAS REPORTED THAT TWO (2) RULERS WERE CORRODED. AS THIS WAS NOTICED UPON CLEANING AND STERILIZATION ACTIVITIES, THERE WAS NOT PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14131674 ↗MalfunctionSep 28, 2021Break; Break
IT WAS REPORTED THAT, A RULER IS BROKEN AT JUNCTION. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT ANY PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12544721 ↗MalfunctionApr 21, 2021Break; Break
IT WAS REPORTED THAT RULERS WERE FOUND BROKEN. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11704290 ↗MalfunctionApr 21, 2021Break; Break
IT WAS REPORTED THAT RULERS WERE FOUND BROKEN. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11704287 ↗
Other TAPE, MEASURING, RULERS AND CALIPERS devices
- TRIGEN 71674079Smith & Nephew, Inc. · TAPE, MEASURING, RULERS AND CALIPERS454 reports
- P.F.C. 86-9188Depuy (Ireland) · TAPE, MEASURING, RULERS AND CALIPERS19 reports
- NA 03.501.065Synthes GmbH · TAPE, MEASURING, RULERS AND CALIPERS2 reports
- TRIGEN MAX 72502005Smith & Nephew, Inc. · TAPE, MEASURING, RULERS AND CALIPERS1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.