Lone Star 3311-8GRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888937015485), received between Mar 10, 2023 and Mar 10, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 10, 2023Break; Break

  CUSTOMERS REPORTED THAT THE ELASTIC STAYS (#3311-8G) WERE KEPT INTACT WHEN REMOVED FROM THE PACKAGE. HOWEVER, WHEN THE ELASTIC STAY WAS BEING USED IN THE SURGERY, IT BROKEN SUDDENLY AND SO THE NURSE WAS SCRATCHED BY THE HOOK. FOLLOW UP INFORMATION: 1. WAS THE SCRATCHED DEEP NEEDING ANY IMMEDIATE MEDICAL ATTENTION? YES. THE HOOK SCRATCHED THROUGH THE GLOVE AND THE NURSE'S HAND DURING THE OPERATION, SO THE NURSE NEEDS TO CLEAN THE WOUND IMMEDIATELY 2. WAS THE SCRATCH SURFACE DEEP NO BLOOD? IT'S ABOUT 3-4MM LENGTH AND 1-2MM DEPTH 3. HOW IS THE NURSE/SCRATCH NOW.? SHE IS RECOVERED ALREADY. 5MM ELASTIC STAYS 8-PK 3311-8G E-COMPLAINT (B)(4).

  Patient problems: Laceration(s)

  MAUDE report 16527072 ↗