INTRAFIX 254832Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886705026302), received between Dec 19, 2018 and Oct 7, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 7, 2020Difficult to Advance; Difficult to Advance

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT BEFORE AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION THE LARGE 23 MM SHEATH INSERTER WAS CLOGGED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10645587 ↗
• MalfunctionDec 19, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THIS IS REPORT 5 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 8182067 ↗