INTRAFIX 254833Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886705026333), received between Dec 19, 2018 and Jul 3, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (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. 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.

• MalfunctionJul 3, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE INTRFX ADV - LG 30MM INSERTER DEVICE AND THE INTRFX ADV - SM 30MM INSERTER DEVICE WERE BENT ON THE INSERTING TIP. THERE WAS NO DELAY TO A PROCEDURE REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2025. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 2 OF (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22395310 ↗
• MalfunctionSep 26, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED BY THE SALES REP IN AUSTRALIA THAT PREOPERATIVELY TO AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE SMALL 30 MM SHEATH INSERTER DEVICE HAD UNKNOWN DEBRIS. IT WAS UNKNOWN IF AND HOW THE PROCEDURE WAS COMPLETED. 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 17818155 ↗
• MalfunctionDec 19, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THIS IS REPORT 6 OF 9 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP THAT PRIOR TO AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE DURING STERILIZATION, THE SALES REP'S INTRAFIX SMALL TRIAL, INTRAFIX LARGE TRIAL, INTRAFIX EXTRA LARGE TRIAL, INTRAFIX SMALL 23MM SHEATH INSERTER, INTRAFIX LARGE 23MM SHEATH INSERTER, INTRAFIX SMALL 30MM SHEATH INSERTER, INTRAFIX LARGE 30MM SHEATH INSERTER, INTRAFIX EXTRA LARGE 30MM SHEATH INSERTER, AND INTRAFIX HEX DRIVER ALL HAD BLOOD RESIDUE IN THE CANNULATED PORTIONS OF THE DEVICES. THE SALES REP STATED THAT THE FACILITY ATTEMPTED TO STERILIZE THE DEVICES THREE TIMES AND THE DEVICES COULD NOT BE CLEANED. THE CASE WAS COMPLETED WITH ANOTHER SET WITH NO PATIENT HARM OR DELAY. THE SALES REP COULD NOT PROVIDE LOT NUMBERS FOR THE DEVICES. THE DEVICES ARE BEING RETURNED FOR EVALUATION. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8182081 ↗