INTRAFIX 254616Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886705013142), received between Aug 24, 2018 and Sep 26, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionSep 26, 2019Material Deformation; Material Deformation

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ANT.CRUCIATE LIGAMENT (ACL) RECONSTRUCTION THE INTRAFIX TIBIAL SHEATH INSERTER BENT ON THE SHAFT WHEN IT WAS PLACED INTO THE TIBIAL TUNNEL FOR FIXATION. THE CASE WAS COMPLETED WITH ANOTHER LIKE-DEVICE AND WITH NO PATIENT HARM OR DELAY. THE DEVICE WAS DISCARDED BY THE CUSTOMER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9123876 ↗
• MalfunctionAug 24, 2018Break; Break

  IT WAS REPORTED THAT UPON RETURN OF A LOANER KIT, THE TIP OF ONE (1) INTRAFIX TIBIAL SHEATH INSERTER, FIXED HANDLE WAS FOUND BROKEN. THIS CASE HAS BEEN REPORTED BY THE LOAN KIT TECHNICIAN DURING LOAN KIT INSPECTION. THE INSTRUMENT HAD FURTHER BEEN ASSESSED BY DEPUY ENGINEERING. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY A CUSTOMER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7813767 ↗