INTRAFIX 254825Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886705027521), received between Jun 15, 2018 and Mar 3, 2022 — classified as 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 3, 2022Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT ONE SIDE OF THE SHEATH QUADRANT ON THE INTRAFX ADV POLYPROSHTHSM 30MM DEVICE WAS BENT; AND WAS NOT SEATING ON THE SHEATH INSERTER CORRECTLY PRIOR TO INSERTING. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A MINUTE OF DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13663472 ↗
• MalfunctionOct 8, 2019Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN ACL PROCEDURE WHEN DOING THE TIBIAL SIDE THEIR PP INTRAFIX ADVANCE SHEATH SMALL 30 MM PROTRUDED THROUGH THE TUNNEL AND JOINT SPACE. THE SURGEON USED A PROBE TO FIND THE DEVICE AND REMOVE IT FROM THE JOINT SPACE WITH NO FURTHER ISSUES. THE PROCEDURE WAS COMPLETED WITH ANOTHER LIKE DEVICE USING THE SAME TUNNEL WITH NO PATIENT HARM BUT THERE WAS A FIVE MINUTE SURGICAL DELAY TO THE CASE. THE SALES REP STATED THAT THE FACILITY IS A TEACHING HOSPITAL AND THAT A RESIDENT WAS DOING THIS PART OF THE CASE SO THERE WAS A TECHNIQUE ISSUE. THE DEVICE WAS DISCARDED BY THE CUSTOMER.

  Patient problems: Not Applicable

  MAUDE report 9169340 ↗
• MalfunctionJun 15, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  ADDITIONAL EVENT INFORMATION RECEIVED ON 05/22/2018. 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; No Known Impact Or Consequence To Patient

  MAUDE report 7606433 ↗