AUTOFIX 451-1136Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03700586903463), received between Oct 23, 2018 and Oct 23, 2018 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 23, 2018Adverse Event Without Identified Device or Use Problem

  SETTING UP AUTOFIX SCREW 2.0. ONE MONTH AFTER APPEARANCE OF AN INFLAMMATORY PHENOMENON WITH REDNESS AND DIGITAL SWELLING IN TWO PATIENTS. INFLAMMATORY REACTION AND LOCAL DISCOMFORT FOR PATIENTS. THIS PI REPRESENTS THE SECOND PATIENT.

  Patient problems: Discomfort; Erythema; Inflammation; Reaction; Swelling

  MAUDE report 7997916 ↗
• InjuryOct 23, 2018Insufficient Device Problem Information

  SETTING UP AUTOFIX SCREW 2.0. ONE MONTH AFTER APPEARANCE OF AN INFLAMMATORY PHENOMENON WITH REDNESS AND DIGITAL SWELLING IN TWO PATIENTS. INFLAMMATORY REACTION AND LOCAL DISCOMFORT FOR PATIENT PAIN, SWELLING, LOCAL FLUID DRAINAGE

  Patient problems: Discomfort; Erythema; Fluid Discharge; Inflammation; Pain; Swelling

  MAUDE report 7997910 ↗
• InjuryOct 23, 2018Insufficient Device Problem Information

  SETTING UP AUTOFIX SCREW 2.0. ONE MONTH AFTER APPEARANCE OF AN INFLAMMATORY PHENOMENON WITH REDNESS AND DIGITAL SWELLING IN TWO PATIENTS. INFLAMMATORY REACTION AND LOCAL DISCOMFORT FOR PATIENT PAIN, SWELLING, LOCAL FLUID DRAINAGE.

  Patient problems: Discomfort; Erythema; Fluid Discharge; Inflammation; Pain; Swelling

  MAUDE report 7997907 ↗