INTRAFIX 254669Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886705013517), received between Aug 11, 2018 and Jun 7, 2022 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 7, 2022Crack; Crack

  THIS IS REPORT 6 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 14626757 ↗
• MalfunctionJun 7, 2022Crack; Crack

  THIS IS REPORT 2 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 14626634 ↗
• MalfunctionSep 13, 2019Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING ANTERIOR CRUCIATE LIGAMENT (ACL) RECONSTRUCTION SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE HANDLE ON THE FEMORAL INTRAFX SHTH INSRTR8MM BROKE WHILE BEING MALLETED AT THE END OF THE PROCEDURE. THE DOCTOR FINISHED THE PROCEDURE WITH NO PATIENT CONSEQUENCES. IT WAS NOT REPORTED IF THERE WAS A DELAY IN THE SURGICAL PROCEDURE. IT WAS NOT REPORTED IF A SPARE DEVICE AVAILABLE FOR USE TO COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9038547 ↗
• MalfunctionAug 11, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ACL PROCEDURE BOTH THE CUSTOMER'S INTRAFIX SHEATH INSERTER AND FEMORAL SHEATH INSERTER BROKE AT THE HANDLE IN THIS CASE WHILE BEING MALLETED. THE SALES REP WAS NOT PRESENT AT THE CASE, AND THERE WERE NO REPORTED PATIENT CONSEQUENCES. THEY SWAPPED THE DEVICES WITH OTHER LIKE DEVICES TO COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7775614 ↗