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EVOS 71174928Recalls & reported problems

Smith & Nephew, Inc. · DEPTH GAUGE FOR 2.4MM AND 2.7MM SCREWS · Class 1

Adverse event reports
9
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00885556387696), received between Sep 17, 2019 and Sep 27, 2022 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (8 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

  • Break8
  • Material Twisted/Bent2
  • Fracture1
  • Material Deformation1

Patient problems

  • No Clinical Signs, Symptoms or Conditions8
  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 27, 2022Fracture; Fracture

    IT WAS REPORTED THAT, DURING A TRAUMA SURGERY THE HOOK OF A DEPTH GAUGE FOR 2.4MM AND 2.7MM SCREWS BROKE OFF. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED AND IF THIS INCIDENT CAUSED A DELAY. NO HARM TO THE PATIENT OR FURTHER COMPLICATIONS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15491726 ↗
  • MalfunctionMay 11, 2022Break; Material Deformation; Break; Material Deformation

    IT WAS REPORTED THAT THE TIP OF A SHORT DEPTH GAUGE 2.4 MM/2.7 MM SCREWS IS BROKEN AND BENT. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14352609 ↗
  • MalfunctionFeb 27, 2022Break; Break

    IT WAS REPORTED THAT THE DEPTH MEASURE OF AN EVOS DEPTH GAUGE FOR 2.4MM AND 2.7MM SCREWS BROKE. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13615275 ↗
  • MalfunctionDec 21, 2021Break; Material Twisted/Bent; Break; Material Twisted/Bent

    IT WAS REPORTED THAT, THE TIP OF THE DEPTH GAUGE FOR 2.4MM AND 2.7MM SCREWS WAS FOUND DURING INSPECTION BENT AND BROKEN, RENDERING IT UNUSABLE. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13056611 ↗
  • MalfunctionAug 12, 2021Break; Break

    IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, A DEPTH GAUGE FOR 2.4MM AND 2.7MM SCREWS BROKE DURING PLATE PROCEDURE. INCIDENT OCCURRED WHILE INSTRUMENT WAS OUTSIDE THE PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12316036 ↗
  • MalfunctionMar 29, 2021Break; Break

    IT WAS REPORTED THAT, THE WIRE PORTION OF DEPTH GAUGE FOR 2.4MM AND 2.7MM SCREWS BROKE. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11586433 ↗
  • MalfunctionMar 8, 2021Break; Material Twisted/Bent; Break; Material Twisted/Bent

    IT WAS REPORTED THAT, THE MEASURING END OF A DEPTH GAUGE FOR 2.4MM AND 2.7MM SCREWS WAS BENT SEVERELY AND WHEN BENT BACK BROKE IN HALF. THIS HAPPENED AFTER PROCEDURE. NO FURTHER COMPLICATIONS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11431019 ↗
  • MalfunctionFeb 28, 2021Break; Break

    IT WAS REPORTED THAT THE DEPTH GAUGE BROKE. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS PATIENT INVOLVEMENT. 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 11391066 ↗
  • MalfunctionSep 17, 2019Break; Break

    IT WAS REPORTED THAT THE TIP OF THE DEPTH GAUGE BROKE OFF AND HAD TO BE EXTRACTED OFF THE PATIENT. NO DELAY REPORTED. NO PATIENT INJURIES REPORTED. AN S&N BACKUP WAS AVAILABLE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9079870 ↗

Other GAUGE, DEPTH devices

All GAUGE, DEPTH devices →

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