INTRAFIX 254809Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10886705026685), received between May 1, 2019 and Sep 10, 2026 — classified as 3 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Break” (5 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.

• MalfunctionSep 10, 2026Break

  It was reported that during an unspecified surgical procedure, it was discovered that when the screw on the INTRAFX ADVBR SCW10X30W/LGSHTH device was inserted, it broke off. All the broken pieces were removed from the patient. 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 50716581 ↗
• MalfunctionMar 18, 2026Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY, THE INTRAFX ADVBR SCW10X30W/LGSHTH SCREW WAS BROKEN. ALL THE PIECES WERE REMOVED FROM THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS A TEN MINUTE DELAY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24625496 ↗
• InjuryJan 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED THROUGH POST MARKET STUDIES THAT A PATIENT UNDERWENT AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY ON (B)(6) 2024 USING A RGDFIX FEM3.3MM ST BR XPIN KIT DEVICE AND INTRAFX ADVBR SCW10X30W/LGSHTH DEVICE ALONG WITH A SPEEDTRAP GRN/WHITE 30MM 4PK DEVICE AND SPEEDTRAP WHITE 30MM 4PK DEVICE. ACCORDING TO THE REPORTER, THE PATIENT REPORTED POST OPERATIVE JOINT STIFFNESS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury

  MAUDE report 21137247 ↗
• MalfunctionAug 31, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY BUYER THAT UNDER ORDER (B)(4) THEY RECEIVED TWO (2) PRODUCTS 254809 INTRAFIX ADVANCE BR SCREW 10 X 30 MM W/LG SHEATH MISLABELED AS 254807 INTRAFIX ADVANCE BR SCREW 8 X 30 MM W/SM SHEATH. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17662626 ↗
• MalfunctionAug 31, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY BUYER THAT UNDER ORDER 127810859/PO 100009101 THEY RECEIVED TWO (2) PRODUCTS 254809 INTRAFIX ADVANCE BR SCREW 10 X 30 MM W/LG SHEATH MISLABELED AS 254807 INTRAFIX ADVANCE BR SCREW 8 X 30 MM W/SM SHEATH. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17662622 ↗
• InjuryJul 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS REPORT 5 OF 5 FOR (B)(4). IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THROUGH CLINICAL RESEARCH THAT A PATIENT UNDERWENT AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH MENISCAL REPAIR PROCEDURE OF THE LEFT KNEE ON (B)(6) 2023 USING A INTRAFIX ADVANCE BR SCREW 10 X 30 MM W/LG SHEATH DEVICE. ACCORDING TO THE REPORT, THE PATIENT HAD A REVISION/REOPERATION PROCEDURE ON (B)(6) 2023 DUE TO AN INFECTION. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 17310576 ↗
• MalfunctionJun 1, 2022Break; Break

  IT WAS REPORTED BY SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE INTRAFX ADVBR SCW10X30W/LGSHTH DEVICE BROKE DURING TAPPING. ACCORDING TO THE REPORT, THE SURGEON REMOVED THE BROKEN SHEATH FROM THE BONE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14567615 ↗
• InjuryAug 14, 2019Migration; Migration

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN ACL PROCEDURE THEIR INTRAFIX ADVANCE BR SCREW 10X30MM WITH LARGE SHEATH WHEN THE SCREW WAS INSERTED INTO THE SHEATH, THE SHEATH DID NOT HOLD IN THE PATIENT. WHEN THEY TRIED THEIR 10X23MM MILAGRO ADVANCE INTERFERENCE SCREW THAT ALSO DID NOT HOLD IN THE PATIENT. THE PROCEDURE WAS COMPLETE WITH A COMPETITOR'S DEVICE WITH A NEW BONE HOLE CREATED. THERE WAS NO PATIENT CONSEQUENCES BUT THERE WAS A 20 MINUTE SURGICAL DELAY TO THE CASE. THE SALES REP STATED THAT THE PATIENT WAS AN OLDER PERSON WITH SOFT BONE QUALITY. THE SALES REP STATED THAT THE DEVICES WERE DISCARDED BY THE CUSTOMER. THIS REPORT IS FOR ONE (1) INTRAFX ADVBR SCW10X30W/LGSHTH. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8895291 ↗
• MalfunctionMay 14, 2019Break; Break

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN ACL RECONSTRUCTION PROCEDURE THE SALES REP'S 10X30 INTRAFIX ADVANCE SCREW AND 9X30 INTRAFIX ADVANCE SCREW SHEATHS BROKE DURING INSERTION. THE SALES REP STATED THAT THE IMPLANTS WERE FULLY REMOVED FROM THE PATIENT WITH A HEMOSTAT. THE IMPLANTS WERE BEING USED IN CONJUNCTION WITH A SIZE 9 GRAFT, A 9.5 TUNNEL, AND A LARGE TRIAL. THE SALES REP STATED THAT THE INSERTION OF THE IMPLANTS WAS NOT OFF AXIS. THE CASE WAS COMPLETED WITH ANOTHER LIKE-IMPLANT IN THE SAME BONE HOLE WITH NO PATIENT HARM OR DELAY. THE IMPLANTS WERE DISCARDED BY THE CUSTOMER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8609921 ↗
• MalfunctionMay 1, 2019Break; Break

  IT WAS REPORTED THAT DURING AN ALLOGRAFT ACL RECONSTRUCTION PROCEDURE THE 10X30 INTRAFIX ADVANCE SCREW WITH LARGE SHEATH BROKE WHILE FIXATING TO THE SIZE 10 INTRAFIX ADVANCE GRAFT AND INSERTING THE ANCHOR INTO THE PATIENT. THE BREAKAGE CAUSED THE GRAFT TO ROTATE DURING INSPECTION. FRAGMENTS WERE CREATED AND SUCCESSFULLY REMOVED. THE CASE WAS COMPLETED WITH NO PATIENT HARM OR SURGICAL DELAY. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8569312 ↗