INTRAFIX 254802Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10886705026746), received between Jul 29, 2025 and Sep 30, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (9 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.

• MalfunctionSep 30, 2026Break

  It was reported that during tan unspecified surgery, the INTRAFIX sheath was broken off. Another device was used to complete the surgery. There were no adverse consequences to the patient and no surgical delay. No additional information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50943640 ↗
• MalfunctionSep 9, 2026Break

  It was reported that during Cruciate ligament reconstruction surgery, the sheath on the INTRAFIX was broken off, all the pieces were removed from the patient. Changed another one to continue the surgery, the same problem happened again. Another device was used to complete the surgery. There were no adverse consequences to the patient. No additional information could be provided.Report 1 of 2 for (b)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50695623 ↗
• MalfunctionSep 9, 2026Break

  It was reported that during Cruciate ligament reconstruction surgery, the sheath on the INTRAFIX was broken off, all the pieces were removed from the patient. Changed another one to continue the surgery, the same problem happened again. Another device was used to complete the surgery. There were no adverse consequences to the patient. No additional information could be provided.Report 2 of 2 for PC-(b)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50695611 ↗
• MalfunctionAug 27, 2026Break

  It was reported that during an Anterior Cruciate Ligament Reconstruction procedure, it was discovered that the sheath on the INTRAFX ADVBR SCW9X23 W/LGSHTH device broke off. All the broken parts were removed. It was not reported if there were any delays to the surgical procedure. It was reported that a spare device was used to complete the surgery. There were no reports of injuries, medical intervention or prolonged hospitalization. All available information has been disclosed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50474503 ↗
• MalfunctionJul 27, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50011887 ↗
• MalfunctionMay 26, 2026Break

  IT WAS REPORTED THAT DURING KNEE ARTHROSCOPY SURGERY, WHEN INSERTING THE INTRAFIX SCREW DEVICE, THE SCREW WAS BROKEN, ALL THE PIECES WERE REMOVED FROM THE PATIENT. 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 25278880 ↗
• MalfunctionApr 8, 2026Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED KNEE ARTHROSCOPIC PROCEDURE THAT THE INTRAFX ADVBR SCW9X23 W/LGSHTH ANCHOR SCREW DEVICE BROKE. ALL PIECES WERE REMOVED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24821737 ↗
• MalfunctionMar 2, 2026Break

  THIS IS REPORT 1 OF 2 OF (B)(4). IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT THE INTRAFX ADVBR DEVICE SCREW AND THE GRYPHON P BR DS ANCHOR W/OC BROKE OFF. ALL BROKEN PARTS WERE REMOVED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 24490924 ↗
• MalfunctionJul 29, 2025Break; Break

  REPORT 6 OF 6 FOR (B)(4). IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPIC CRUCIATE LIGAMENT RECONSTRUCTION SURGERY+KNEE ARTHROSCOPIC HALF MOON SUTURE SURGERY, IT WAS OBSERVED THAT 5X TRUESPAN 24 DEGREE PEEK DEVICES COULD NOT FIRE AND AN INTRAFX ADVBR SCW9X23 W/LGSHTH DEVICE WAS BROKEN. ANOTHER DEVICES 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 22644825 ↗