INTRAFIX 254643Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10886705013357), received between Jul 12, 2018 and Dec 18, 2022 — classified as 11 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 18, 2022Break; Break

  IT WAS REPORTED BY THE SALES REP IN UNITED KINGDOM THAT THE BIOINTRAFIX TIBIAL SHEATH TRIAL, 9MM WITH T-HANDLE DEVICE WAS BROKEN IN TWO PIECES. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16001599 ↗
• MalfunctionJun 25, 2021Break; Break

  IT WAS REPORTED BY THE SALES REP IN (B)(6) THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT THE INTRAFIX TIBSHEATH TRIAL/T-HDLE DEVICE BROKE DURING REMOVAL. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE HANDLE AND THE T-PIECE WERE BROKEN. THERE WAS A DELAY OF FIVE MINUTES 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 12066886 ↗
• MalfunctionNov 16, 2020Break; Break

  IT WAS REPORTED VIA COMPLAINT SUBMISSION TOOL THAT DURING AN ACL RECONSTRUCTION A BIOINTRAFIX TIBIAL SHEATH TRIAL, 9MM WITH T-HANDLE BROKE DURING USE. NO SURGICAL DELAY OR PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10844838 ↗
• MalfunctionApr 21, 2020Break; Break

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN ACL PROCEDURE THE BIOINTRAFIX TIBIAL SHEATH TRIAL, 9MM WITH T-HANDLE BROKE WHEN THE SURGEON WAS MAKING THE PILOT HOLE FOR THE IMPLANT. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. THE DEVICE WAS DISCARDED. ADDITIONAL INFORMATION RECEIVED FROM THE AFFILIATE REPORTED THE CASE WAS COMPLETED WITH ANOTHER SET OF IN-HOUSE INSTRUMENTS. THE AFFILIATE ALSO REPORTED THE LOT NUMBER OF THE DEVICE IS NOT AVAILABLE BECAUSE THE DEVICE WAS DISCARDED. IT WAS REPORTED THE HANDLE BROKE AT THE BASE OF THE "T" DURING IMPACTION AND NO SURGICAL INTERVENTION NEEDED OR PLANNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9983547 ↗
• MalfunctionDec 10, 2019Break; Break

  IT WAS REPORTED BY THE AFFILIATE VIA COMPLAINT SUBMISSION TOOL, DURING AN ACL REPAIR PROCEDURE THE INTRAFIX TIBIAL SHEATH INSERTER BROKE WHILE INSERTING. THE AFFILIATE COULD NOT PROVIDE ADDITIONAL DETAILS ON HOW THE PROCEDURE WAS COMPLETED OR ON PATIENT STATUS ALTHOUGH IT WAS REPORTED A SURGICAL DELAY DID NOT OCCUR.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 9447494 ↗
• MalfunctionApr 4, 2019Crack; Crack

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A KNEE ARTHROSCOPY WITH ACL RECONSTRUCTION PROCEDURE THE CUSTOMER'S INTRAFIX TIBIAL SHEATH TRIAL SHAFT BROKE WHILE IT WAS BEING MALLETED TO DILATE THE TUNNEL. THE SALES REP STATED THAT NO FRAGMENTS WERE CREATED AND THE DEVICE WAS REMOVED FROM THE PATIENT. THERE WERE NO UNUSUAL PROCEDURAL OR ANATOMY FACTORS THAT CONTRIBUTED TO BREAKAGE. THE CUSTOMER'S 7MM INTRAFIX SHEATH INSERTER HANDLE CRACKED FROM BEING MALLETED. THE CASE WAS COMPLETED WITH ANOTHER SET OF DEVICES WITH NO PATIENT HARM OR DELAY. THE SALES REP COULD NOT PROVIDE LOT NUMBERS. THE DEVICES ARE BEING RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8483647 ↗
• MalfunctionJan 30, 2019Fracture; Fracture

  IT WAS REPORTED THAT PRIOR TO AN ACL PROCEDURE THE TIP OF THEIR INTRAFIX TIBIAL SHEATH TRIAL T-HANDLE WAS BENT AND BROKE OFF IN THE TRAY BEFORE BEING USED ON THE PATIENT. IT WAS STATED THAT NOTHING BROKE IN THE PATIENT AND THE DEVICE FAILURE OCCURRED BEFORE BEING USED ON THE PATIENT. THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER LIKE DEVICE WITH NO PATIENT CONSEQUENCES OR DELAYS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8289008 ↗
• MalfunctionJan 29, 2019Fracture; Fracture

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT THE INTRAFIX TIBSHEATH TRIAL/T-HDLE *EA DEVICE WAS FOUND BROKEN DURING CLEANING. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO 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 REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8284681 ↗
• MalfunctionSep 3, 2018Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING ANTERIOR CRUCIATE LIGAMENT (ACL) REPAIR SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE INTRAFIX STANDARD TRIAL, W/T-HANDLE SHEATH DEVICE TRIAL BROKE. THE DEVICE WAS DISCARDED. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7840849 ↗
• MalfunctionJul 13, 2018Break; Break

  OUR AFFILIATE REPORTED THAT THE INSTRUMENT SNAPPED IN HALF WHEN THE SHEATH WAS BEING MALLETED BACKWARDS OUT PATIENTS TIBIA DURING AN ACL PROCEDURE. THE SURGEON NEEDED TO USE PLIERS TO REMOVE THE PIECE LODGE IN PATIENTS TIBIA. OPENED A SECOND TRAY OF INSTRUMENTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7686984 ↗
• MalfunctionJul 12, 2018Break; Break

  OUR AFFILIATE REPORTED THE INSTRUMENT SNAPPED IN HALF WHEN THE SHEATH WAS BEING MALLETED INTO PATIENTS TIBIA DURING AN ACL PROCEDURE. OPENED A SECOND TRAY OF INSTRUMENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7682762 ↗