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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

All TAPE, MEASURING, RULERS AND CALIPERS devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.