EVOS 71175066Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885556635841), received between Jun 29, 2020 and Jan 17, 2024 — classified as 4 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.

• MalfunctionJan 17, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A PLATING CASE, THE EVOS SMALL 2.7MM DEPTH GAUGE LONG HAS BROKEN OFF. ALL PARTS RETRIEVED AND ACCOUNTED FOR, UNSURE WITH WHAT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18526971 ↗
• MalfunctionOct 17, 2023Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE HOOK CAME OFF THE EVOS SMALL 2.7MM DEPTH GAUGE LONG DURING USE ON A PATIENT. ALL PARTS WERE ACCOUNTED FOR. THE PROCEDURE WAS RESUMED WITHOUT ANY DELAY, USING A S+N BACKUP DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17949963 ↗
• MalfunctionDec 29, 2020Break; Break

  IT WAS REPORTED THAT DURING SET UP THE DEVICE SNAPPED AND BROKE OFF. THE PROCEDURE FINISHED WITH A SMITH AND NEPHEW BACKUP DEVICE. NO SURGICAL DELAY. PATIENT INJURIES WERE NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11086908 ↗
• MalfunctionJun 29, 2020Break; Break

  IT WAS REPORTED THAT DURING SURGERY THE TIP BROKE OFF THE GAUGE OUTSIDE OF THE PATIENT. EVOS SMALL CASE. THERE WAS NO DELAY NOR INJURY REPORTED. A S&N BACKUP DEVICE WAS AVAILABLE TO FINISH THE SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10205187 ↗

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.