ORTHOPEDIC MANUAL SURGICAL INSTRUMENT 951-0023Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03701037316894), received between May 5, 2025 and May 5, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 5, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DURING A CASE WITH THE SURGEON ON (B)(6) 2025, THE DRILL GUIDE WAS DISCOVERED TO HAVE BONE DEBRIS OBSTRUCTING THE CANNULA. THE INSTRUMENT WAS FLUSHED WITH BETADINE WASH IN THE SURGICAL SUITE, AS THE SURGEON FELT THE DEBRIS WAS AT LEAST STERILE. THERE WAS NO SURGICAL DELAY. A PHOTO RETURNED DOES CONFIRM THE ISSUE. THE INSTRUMENT SET IN QUESTION HAS BEEN IDENTIFIED. IT WAS SHIPPED TO THE DISTRIBUTOR, AND IS NOT YET RETURNED TO FX SHOULDER SOLUTIONS. THE CASE PERFORMED ON 23-APR-2025 BY THE DISTRIBUTOR WAS THE FIRST CASE PERFORMED DURING THIS TIME. THE INSTRUMENT IN QUESTION WAS NOT ADEQUATELY INSPECTED OR CLEANED BY FX SHOULDER SOLUTIONS WAREHOUSE STAFF. CAPA-2025-0030 HAS BEEN OPENED TO ADDRESS THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21963608 ↗
• MalfunctionMay 5, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DURING A CASE WITH THE SURGEON ON (B)(6) 2025, THE DRILL GUIDE WAS DISCOVERED TO HAVE BONE DEBRIS OBSTRUCTING THE CANNULA. THERE WERE 20 MINUTES OF SURGICAL DELAY AS THE SURGICAL TEAM USED ANOTHER SET OF INSTRUMENTATION TO CONTINUE THE SURGERY. THE INSTRUMENT SET IN QUESTION HAS BEEN IDENTIFIED. IT WAS SHIPPED TO THE DISTRIBUTOR 14-APR-2025, AND RETURNED TO FX SHOULDER SOLUTIONS ON 23-APR-2025. THE CASE PERFORMED ON 17-APR-2025 WAS THE ONLY CASE PERFORMED BY THE DISTRIBUTOR. THE INSTRUMENT IN QUESTION WAS NOT ADEQUATELY INSPECTED OR CLEANED BY FX SHOULDER SOLUTIONS WAREHOUSE STAFF. CAPA-2025-0030 HAS BEEN OPENED TO ADDRESS THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21963607 ↗