INTRAFIX 254826Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10886705027538), received between Apr 30, 2018 and Oct 5, 2018 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (8 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryOct 5, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  ADDITIONAL INFORMATION RECEIVED ON 05-OCTOBER-2018: THE PATIENT WAS EXPERIENCING STIFFNESS FOLLOWING THE FIRST PROCEDURE IN (B)(6).

  Patient problems: Muscular Rigidity; Tissue Damage

  MAUDE report 7939882 ↗
• MalfunctionJun 11, 2018Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED VIA PHONE BY THE SALES REP THAT HIS LARGE 30MM INTRAFIX ADVANCE BOX HAD A BLUE LABEL INSTEAD OF PURPLE DURING AN ACL PROCEDURE. THE DEVICE WAS USED SINCE THE ISSUE WAS ONLY THE LABEL COLOR. NO COMPLAINT DEVICE IS BEING RETURNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7586305 ↗
• MalfunctionMay 17, 2018Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED BY THE SALES REP WHILE CHECKING HIS TRUNK STOCK THAT HE RECEIVED TWO OF THE LARGE 30 MM INTRAFIX ADVANCE SHEATH WITH A BLUE LABEL INSTEAD OF PURPLE FROM THE SAME LOT NUMBER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7524208 ↗
• MalfunctionMay 17, 2018Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED BY THE SALES REP WHILE CHECKING HIS TRUNK STOCK THAT HE RECEIVED TWO OF THE LARGE 30 MM INTRAFIX ADVANCE SHEATH WITH A BLUE LABEL INSTEAD OF PURPLE FROM THE SAME LOT NUMBER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7524136 ↗
• MalfunctionMay 17, 2018Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED BY THE SALES REP WHILE CHECKING HIS TRUNK STOCK THAT HE RECEIVED TWO OF THE LARGE 30 MM INTRAFIX ADVANCE SHEATH WITH A BLUE LABEL INSTEAD OF PURPLE FROM THE SAME LOT NUMBER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7523866 ↗
• MalfunctionMay 10, 2018Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED BY THE SALES REP THAT THE LABEL ON THE THEIR LARGE 30 MM INTRAFIX ADVANCE SHEATH WAS BLUE WHEN THE COLOR SHOULD BE PURPLE PRIOR TO AN ACL PROCEDURE. THE CASE WAS COMPLETED WITH ANOTHER LIKE DEVICE. THERE WERE NO PATIENT CONSEQUENCES OR DELAYS. THE SALES REP PROVIDED A PICTURE AND THE DEVICE WILL NOT BE RETURNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7502776 ↗
• MalfunctionMay 9, 2018Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED BY THE SALES REP THAT THE LABEL ON HIS LARGE 30 MM INTRAFIX ADVANCE SHEATH WAS BLUE WHEN THE COLOR SHOULD BE PURPLE WHILE CHECKING HIS TRUNK INVENTORY. PHOTOS HAVE BEEN PROVIDED. THE SALES REP HAS BEEN INFORMED TO RETURN THE COMPLAINT DEVICE DIRECTLY TO DEPUY MITEK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7500635 ↗
• MalfunctionMay 7, 2018Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED BY THE SALES REP THAT HE RECEIVED A LARGE 30 MM INTRAFIX ADVANCE SHEATH WITH BLUE LABELING INSTEAD OF PURPLE LABELING. THERE WAS NO PATIENT OR CASE INVOLVEMENT. THE DEVICE IS NOT BEING RETURNED. THE SALES REP PROVIDE A PICTURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7490481 ↗
• MalfunctionApr 30, 2018Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED BY THE SALES REP VIA PHONE WHILE SETTING UP FOR AN ACL PROCEDURE, THAT THE LABEL ON HIS LARGE 30MM INTRAFIX ADVANCE SHEATH WAS BLUE INSTEAD OF PURPLE. THEY SWAPPED THE DEVICE WITH ANOTHER LIKE DEVICE TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES OR DELAYS. THE SALES REP HAS BEEN INFORMED TO RETURN THE DEVICES DIRECTLY TO DEPUY MITEK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7473459 ↗