INTRAFIX 254822Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886705027484), received between Jun 15, 2018 and Jan 29, 2026 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (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.

• MalfunctionJan 29, 2026Delivered as Unsterile Product; Packaging Problem

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT PROCEDURE, THE OUTER PACKAGE OF THE INTRAFIX ADV PEEK SCW 9X30MM DEVICE WAS OPENED AND INNER SEAL APPEARED TO BE PUNCTURED. THE FILM AROUND THE SCREW HAS A CLEAR TINY HOLE IN IT WHICH REDUCED OUR CONFIDENCE IN ITS STERILITY. FROM WHAT I COULD TELL THERE WAS NO VISIBLE DAMAGE TO THE BOX. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 24215459 ↗
• MalfunctionDec 10, 2021Break; Break

  IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE TIP ON THE INTRAFIX ADV PEEK SCW (B)(4) DEVICE BROKE AS IT POSSIBLY WENT OFF AXIS. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 12975791 ↗
• InjuryOct 5, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  ADDITIONAL INFORMATION RECEIVED ON 05OCTOBER2018: THE PATIENT WAS EXPERIENCING STIFFNESS FOLLOWING THE FIRST PROCEDURE IN (B)(6).

  Patient problems: Muscular Rigidity; Tissue Damage

  MAUDE report 7939855 ↗
• MalfunctionJun 15, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  ADDITIONAL EVENT INFORMATION RECEIVED ON 5/22/2018. NO REPLACEMENTS WERE ORDERED PER THE SALES REP'S REQUEST INSTEAD A TRUNK STOCK ADJUSTMENT HAS BEEN REQUESTED ON BEHALF OF THE REP PER THEIR REQUEST.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7606430 ↗