INTRAFIX 254834Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886705026319), received between Dec 19, 2018 and Feb 9, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 9, 2026Device-Device Incompatibility; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, AN INTRFX ADV - LG 30MM INSERTER'S CANNULATION CLOGGED. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24294794 ↗
• 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 2 OF 2 OF (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22395314 ↗
• MalfunctionJun 30, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED BY THE SALES REP THAT THE CANNULATED SECTION ON THE LARGE 30 MM SHEATH INSERTER DEVICE WAS CONTAMINATED BY HAVING REMAINS OF BIOBURDEN. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14877310 ↗
• MalfunctionJan 10, 2022Use of Device Problem; Use of Device Problem

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT THE RUBBER MARKER ON THE INTRFX ADV - LG 30MM INSERTER DEVICE WAS MISSING. 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 13205829 ↗
• MalfunctionDec 19, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THIS IS REPORT 7 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 8182072 ↗