EVOS 71175067Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885556635858), received between Dec 29, 2020 and Oct 15, 2022 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K162078); they may or may not involve this specific model.

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

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 15, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, THE FRONT PORTION OF THE EVOS SMALL 2.7MM DEPTH GAUGE SHORT WAS SEEN TO BE MISSING. AS THIS WAS NOTICE IN A FIELD INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15612601 ↗
• MalfunctionSep 9, 2022Fracture; Fracture

  IT WAS REPORTED THAT EVOS SMALL 2.7MM DEPTH GAUGE SHORT DEPTH GAUGE WAS STUCK IN THE TRAY AND THE TIP BROKE OFF WHEN THEY TRIED TO FREE IT WHILE CLEANING IT. AS THIS HAPPENED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15395462 ↗
• MalfunctionFeb 5, 2021Break; Break

  IT WAS REPORTED THAT DURING A TRAUMA CASE THE EVOS SMALL 2.7MM DEPTH GAUGE SHORT BROKE. THIS HAPPENED OUTSIDE THE PATIENT. NO INJURY, NO DELAY. S+N BACKUPS TO ALL. 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 11283960 ↗
• InjuryDec 29, 2020Break; Device Markings/Labelling Problem; Break; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING CASE, BLUE TAPE WAS NOTICED TO BE MISSING COMPLETELY TO IDENTIFY EVOS SMALL 2.7MM DEPTH GAUGE SHORT AND IT HAS SLOWLY CHIPPED OFF WHILE BEING USE. NO DELAY OR INJURY OCCURRED DUE TO THIS EVENT. IT IS UNKNOWN WHO THE PROCEDURE WAS CONCLUDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11087495 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K162078. One submission often covers many models, so check the product and lot details in each record.

• Z-0265-2022 · Oct 25, 2021 · Open, Classified
  Smith and Nephew EVOS Self-Tapping Locking Screw SST: (1)REF 72413575, 3.5MM x 75MM, and (2) REF 72413570, 3.5MM X 70MM. Sterile.