INTRAFIX 254803Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886705026678), received between Sep 25, 2019 and May 27, 2026 — classified as 4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMay 27, 2026Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(4). POST MARKET COMPLICATION RECEIVED FOR RE-TEARS OR NEW TEARS (LEFT KNEE DISPLACED BUCKET HANDLE MEDIAL MENISCUS TEAR), DATE OF EVENT: 17-DEC-2025, DATE OF IMPLANT: ON (B)(6) 2023 (LEFT ACL TEAR, MEDIAL MENISCUS TEAR, LATERAL MENISCUS TEAR), DATE OF REOPERATION/REVISION: ON (B)(6) 2025, DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: RE-OPERATION WITH NO IMPLANT REMOVED/IMPLANTED. DEPUY SYNTHES PRODUCTS USED: RGDLOOP ADJUSTABLE LONG, CATALOG NUMBER: 232448, LOT NUMBER: 8L67308, DEPUY SYNTHES PRODUCTS USED: TRUESPAN 12 DEGREE PEEK, CATALOG NUMBER: 228151, LOT NUMBER: 9L71051, DEPUY SYNTHES PRODUCTS USED: INTRAFIX ADVANCE 10X23 SCREW & LARGE 23MM SHEATH, CATALOG NUMBER: 254803, LOT NUMBER: 9L62950, DEPUY SYNTHES PRODUCTS USED: 5.5MM HEALIX ADVANCE SP BIOCOMPOSITE ANCHOR, CATALOG NUMBER:222424, LOT NUMBER: 116L683. REPORT 3 OF 4 FOR (B)(4).

  Patient problems: Unspecified Tissue Injury

  MAUDE report 25301076 ↗
• InjuryAug 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS REPORT 8 OF 8 FOR (B)(4). IT WAS REPORTED THROUGH CLINICAL RESEARCH STUDY THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) RECONSTRUCTION WITH LATERAL COLLATERAL LIGAMENT (LCL) REPAIR PROCEDURES ON (B)(6) 2023, AN INTRAFX ADVBR SCW10X23W/LGSHTH DEVICE WAS USED. ACCORDING TO THE REPORT, POSTOPERATIVELY ON (B)(6) 2024, THE PATIENT HAD JOINT STIFFNESS WITH REDUCED RANGE OF MOTION. IT WAS REPORTED THAT THE EVENT DID NOT RESULT IN A REOPERATION/REVISION PROCEDURE. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 19950420 ↗
• MalfunctionJul 2, 2024Break; Material Deformation; Break; Material Deformation

  THIS IS REPORT 5 OF 5 FOR PC (B)(4). IT WAS REPORTED THROUGH CLINICAL RESEARCH THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE, IT WAS OBSERVED THAT THE INTRAFX ADVBR SCW10X23W/LGSHTH DEVICE WAS DEFORMED, WARPED AND DISTORTED THAT LED TO DEVICE BREAKAGE. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19657505 ↗
• InjuryNov 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS REPORT 2 OF 3 FOR (B)(4). IT WAS REPORTED THAT AFTER A CLINICAL TRIAL ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE, ON (B)(6) 2023 WITH A RIGIDLOOP ADJUSTABLE CORTICAL DEVICE, 5.5MM HEALX ADV SP PEEK ANCHOR DEVICE AND INTRAFIX ADVANCE BR SCREW 10 X 23 MM W/LG SHEATH DEVICE, THE PATIENT DEVELOPED AN INFECTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 18092457 ↗
• InjuryAug 31, 2023Break; Break

  THIS IS REPORT 2 OF 5 FOR (B)(4). IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THROUGH CLINICAL RESEARCH THAT A PATIENT UNDERWENT AN ARTHROSCOPIC ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE OF THE RIGHT KNEE ON (B)(6) 2023 TREATING AN ACL TEAR. ACCORDING TO THE REPOT, AN INTRAFIX ADVANCE BR SCREW 10 X 23 MM W/LG SHEATH DEVICE WAS USED THAT BROKE POSTOPERATIVELY. IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT A RE-OPERATION/REVISION PROCEDURE FOR LOOSE BODY REMOVAL. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17662385 ↗
• MalfunctionSep 25, 2019Material Twisted/Bent; Material Twisted/Bent

  THIS IS REPORT 1 OF 2 FOR THE SAME EVENT. IT WAS REPORTED VIA PHONE BY THE SALES REP THAT BEFORE ACL (ANT.CRUCIATE LIGAMENT) RECONSTRUCTION SURGICAL PROCEDURE, IT WAS OBSERVED THAT WHEN HE OPENED THE PACKAGE OF HIS INTRAFIX ADVANCE ANCHOR AND MILAGRO ADVANCE SCREW, THEY BOTH HAD BENT TIPS. THE DOCTOR USED DIFFERENT ANCHORS TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES OR DELAYS. THERE WAS NO DELAY IN THE SURGICAL PROCEDURE. THERE WAS A SPARE DEVICE AVAILABLE FOR USE TO COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9117834 ↗