INTRAFIX 254818Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886705027507), received between Jun 13, 2023 and Apr 29, 2024 — classified as 2 malfunctions.

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

• MalfunctionApr 29, 2024Break; Break

  IT WAS REPORTED FROM CHINA THAT DURING AN ANTERIOR CRUCIATE LIGAMENT REPAIR PROCEDURE, IT WAS OBSERVED THAT THE INTRAFIX ADV PEEK SCW 8X23MM AND INTRAFX ADV POLYPROSHTHSM 23MM SHEATH WAS BROKEN OFF. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. IT WAS REPORTED THAT THERE WAS A 10-MINUTE DELAY IN THE PROCEDURE DUE TO THE EVENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 2 OF 2 FOR THE SAME EVENT IN (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19205685 ↗
• MalfunctionJun 13, 2023Break; Break

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN CHINA IN THAT DURING AN UNKNOWN PROCEDURE OF THE KNEE ON (B)(6)2023, IT WAS OBSERVED THAT THE PP INTRAFIX ADVANCE SHEATH, SMALL 23MM DEVICE BROKE OFF. REMOVED ALL THE BROKEN PARTS. CHANGED TO ANOTHER ONE TO CONTINUE THE SURGERY BUT THE SAME PROBLEM HAPPENED AGAIN. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17119578 ↗