INTRAFIX 254801Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10886705026661), received between Oct 8, 2018 and Jun 1, 2026 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Break” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 1, 2026Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) REPAIR PROCEDURE, WHILE USING THE INTRAFX ADVBR SCW 8X23W/SMSHTH DEVICE, IT WAS OBSERVED THAT THE SHEATH WAS BROKEN. IT WAS REPORTED THAT ALL BROKEN PARTS WERE REMOVED AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. IT WAS REPORTED THAT THERE WAS 5-MINUTE DELAY IN THE PROCEDURE DUE TO THE EVENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25351095 ↗
• MalfunctionJan 14, 2026Break

  IT WAS REPORTED THAT DURING ACL (ANT.CRUCIATE LIGAMENT) SURGERY, THE SHEATH WAS NOTED TO BE BROKEN AT IMPLANT. IT WAS REPORTED THAT ALL THE BROKEN PARTS WERE REMOVED AND ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24068282 ↗
• MalfunctionDec 30, 2025Break; Break

  IT WAS REPORTED THAT DURING A LIGAMENT RECONSTRUCTION SURGICAL PROCEDURE IT WAS OBSERVED THAT THE INTRAFX ADVBR SCW 8X23W/SMSHTH DEVICE SHEATH BROKE OFF. ALL BROKEN PARTS WERE REMOVED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTS OF DELAY IN THE PROCEDURE REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23921615 ↗
• MalfunctionDec 30, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT THE INTRAFX ADVBR SCW 8X23W/SMSHTH DEVICE BROKE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTS OF DELAY IN THE PROCEDURE REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23921538 ↗
• MalfunctionNov 19, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT REPAIR (ACL) SURGICAL PROCEDURE IT WAS OBSERVED THAT THE INTRAFX ADVBR SCW DEVICE ANCHOR WAS BROKEN. IT WAS REPORTED THAT DURING THE SURGERY, THE ANCHOR SHEATH WAS BROKEN. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A FIVE MINUTE DELAY IN THE PROCEDURE REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23598440 ↗
• MalfunctionNov 7, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT PROCEDURE, THE INTRAFX ADVBR SCW 8X23W/SMSHTH DEVICE ANCHOR SHEATH WAS BROKEN OFF, REMOVED ALL THE BROKEN PARTS. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23495484 ↗
• MalfunctionSep 10, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY, WHEN INSERTING THE INTRAFX ADVBR SCW 8X23W/SMSHTH DEVICE, THE SHEATH WAS BROKEN OFF. IT WAS REPORTED THAT ALL THE BROKEN PARTS WERE REMOVED. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23019954 ↗
• MalfunctionSep 8, 2025Break; Break

  IT WAS REPORTED THAT DURING A ANTERIOR CRUCIATE LIGAMENT (ACL) RECONSTRUCTION SURGERY, THE INTRAFX ADVBR SCW 8X23W/SMSHTH DEVICE WAS BROKEN OFF. IT WAS REPORTED THAT ALL BROKEN PARTS WERE REMOVED. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22994038 ↗
• MalfunctionJul 12, 2024Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2024 THE INTRAFX ADVBR SCW 8X23W/SMSHTH DEVICE WAS BROKEN. THE INTERFACE NAIL WAS BROKEN OFF DURING IMPLANTATION AND ALL THE BROKEN PARTS WERE REMOVED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19730430 ↗
• InjuryOct 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE SURGEON THAT THE TIBIAL INTRAFIX ADV IMPLANT DEVICE WILL BE REMOVED DUE TO AN ABSCESS AFTER THE INITIAL ACL RECONSTRUCTION. IT WAS FURTHER REPORTED THAT HARDWARE REMOVAL SURGERY HAS ALREADY BEEN SCHEDULED WHILE THE REVISION SURGERY WILL BE DONE AT A LATER DATE. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF PROLONGED HOSPITALIZATION. THE PATIENT'S STATUS POST-SURGERY WAS NOT PROVIDED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Hypersensitivity/Allergic reaction; Not Applicable

  MAUDE report 7942430 ↗