INTRAFIX 254666Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886705013487), received between Mar 17, 2020 and Jun 7, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Crack” (3 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.

• MalfunctionJun 7, 2022Crack; Crack

  THIS IS REPORT 1 OF 7 FOR (B)(4). IT WAS REPORTED BY THE SALES REP THAT TWO OF THE FEMORAL INTRAFIX SHEATH TRIAL, 8MM - 8.5MM, TWO OF THE FEMORAL INTRAFIX SHEATH INSERTER, 8MM - 8.5MM, ONE FEMORAL INTRAFIX SHEATH TRIAL, 9MM - 10MM, ONE FEMORAL INTRAFIX SHEATH INSERTER, 9MM - 10MM AND ONE ACL TIE TENSIONER WERE FOUND CRACKED. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14626749 ↗
• MalfunctionJun 7, 2022Crack; Crack

  THIS IS REPORT 5 OF 7 FOR (B)(4). IT WAS REPORTED BY THE SALES REP THAT TWO OF THE FEMORAL INTRAFIX SHEATH TRIAL, 8MM - 8.5MM, TWO OF THE FEMORAL INTRAFIX SHEATH INSERTER, 8MM - 8.5MM, ONE FEMORAL INTRAFIX SHEATH TRIAL, 9MM - 10MM, ONE FEMORAL INTRAFIX SHEATH INSERTER, 9MM - 10MM AND ONE ACL TIE TENSIONER WERE FOUND CRACKED. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14626446 ↗
• MalfunctionMar 17, 2020Crack; Crack

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN ACL PROCEDURE THE HANDLE OF THE FEMORAL INTRAFIX SHEATH TRIAL, 8 MM-8.5 MM CRACKED. THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. THE DEVICE WAS DISCARDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9844677 ↗