INTRAFIX 254609Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886705013128), received between Jun 1, 2018 and Jul 12, 2022 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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.

• InjuryJul 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A REVIEW OF NEW ZEALAND ACL REGISTRY DEPUY IMPLANT REPORT RECEIVED AS PER IIS (B)(4) CONTRACT MILESTONE DELIVERABLE THAT POSTOPERATIVELY TO AN ANTERIOR CRUCIATE LIGAMENT PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE INTRAFIX TAPERED SCREW 7-9MM X 30MM (ACETAL/DELRIN) DEVICE FAILED THAT REQUIRED A REVISION SURGERY. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 14990443 ↗
• MalfunctionSep 5, 2018Break; Break

  IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT THE INTRAFIX TAPPERED SCREW 7-9MM BROKE IN THE PATIENT; HOWEVER, WAS RETRIEVED BY THE SURGEON. THE SALES REP REPORTED THAT A LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE SALES REP ALSO REPORTED THAT THERE WAS NO DELAY AND NO CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7847711 ↗
• MalfunctionJun 22, 2018Break; Break

  THE SALES REP REPORTED THAT WHILE GOING THROUGH HIS INVENTORY A LARGER PIECE OF HARDWARE FELL ON A COUPLE OF HIS INTRAFIX TAPERED SCREWS BREAKING THEM. THE SALES REP CONFIRMED THEY WERE NOT USED IN A PROCEDURE AND THERE WERE NO PATIENT CONSEQUENCES. THE DEVICES WERE DISCARDED. PLEASE SEE ALSO MEDWATCH REPORT 1221934-2018-50828.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7631142 ↗
• InjuryJun 1, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  POSTOPERATIVE PAIN. THIS IS A LEGAL CASE. THE PATIENT ACCEPTED UNKNOWN PROCEDURE IN 2007. NO ANOMALIES WERE OBSERVED DURING AT THAT TIME. AFTER SEVERAL YEARS PATIENT FELT PAIN AND DOUBTED QUALITY OF IMPLANT. THEN PATIENT SUED HOSPITAL AND REQUESTED QUALITY CERTIFICATION OF DEVICE. FURTHER INFORMATION WILL BE UPDATED IF AVAILABLE.

  Patient problems: Pain

  MAUDE report 7562141 ↗