BIOINTRAFIX 254650Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10886705013418), received between Sep 6, 2018 and May 31, 2023 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 31, 2023Break; Break

  IT WAS REPORTED BY SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT REPAIR PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE BIOINTRAFIX SHEATH TRIAL, SMALL DEVICE BROKE IN HALF. IT WAS UNKNOWN IF AND HOW THE PROCEDURE WAS COMPLETED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17031070 ↗
• MalfunctionFeb 2, 2023Break; Break

  IT WAS REPORTED THROUGH IN-HOUSE DISTRIBUTION THAT DURING INSPECTION, IT WAS OBSERVED THAT THE BIOINTRAFIX SHEATH TRIAL, SMALL DEVICE WAS BROKEN INTO TWO PIECES AT THE SHAFT/HANDLE INTERSECTION. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16285976 ↗
• MalfunctionDec 1, 2020Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN AUSTRALIA THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) PROCEDURE ON (B)(6) 2020, IT WAS OBSERVED THAT THE BIOINTRAFIX 7-8MM SHEATH TRIAL DEVICE BROKE. ACCORDING TO THE REPORT, THE WELD SITE OF HANDLE SHEARED OFF WHILE MALLETING OUT OF TIBIA. THE DEVICE WAS REMOVED MANUALLY AND THE PROCEDURE CONTINUED TO BE COMPLETED SUCCESSFULLY. THERE WERE NO FRAGMENTS GENERATED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10927747 ↗
• MalfunctionJun 23, 2020Break; Break

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN ACL PROCEDURE THE BIOINTRAFIX SHEATH TRIAL, SMALL BROKE IN 2 PIECES WHEN TRYING TO BE REMOVED. NO FRAGMENTS WERE GENERATED. ALSO, THE TIP OF THE TIBIAL GUIDE ARM - TIP AIMER WAS DAMAGED. OTHER DEVICES WERE USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. ONLY THE BIOINTRAFIX SHEATH TRIAL IS AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10187088 ↗
• MalfunctionDec 11, 2019Break; Break

  IT WAS REPORTED BY THE AFFILIATE VIA PHONE THAT DURING AN UNKNOWN PROCEDURE THE BIOINTRAFIX SHEATHTRIAL 9MM *EA WAS BROKEN AND THE BIOINTRAFIX 7-8MM SHEATH TRIAL WAS ON BREAK. NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION REPORTED BY THE AFFILIATE STATED THE HOSPITAL DISPOSED OF THE INSTRUMENTS AND THEY WILL NOT BE RETURNING FOR EVALUATION. IT WAS ALSO REPORTED THE SERVICE TEAM HAS REVIEWED ALL THE ITEMS IN THE KITS AND NOTED WHEN PULLING ON BOTH SIDES OF THE INSTRUMENTS, THE PARTS ARE NOT LOOSE, NEITHER ARE THERE ANY CRACKS ON THE WELDING POINT. HOWEVER, THEY REPORTED IT WAS NOTICED THAT FOR MOST OF THESE ITEMS THERE IS NO LOT NUMBER VISIBLE.

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

  MAUDE report 9452360 ↗
• MalfunctionJan 25, 2019Fracture; Fracture

  IT WAS REPORTED BY THE SALES REP THAT THE CUSTOMER'S BIO INTRAFIX 7-8MM SHEATH TRIAL CRACKED AT THE T-HANDLE JUNCTION DURING AN ANTERIOR CRUCIATE LIGAMENT ACL PROCEDURE. THE SALES REP COULD NOT PROVIDE LOT INFORMATION BUT STATED THE DEVICE IS EIGHT YEARS OLD WITH HEAVY USE. THE CASE WAS COMPLETED WITH ANOTHER LIKE DEVICE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES OR DELAY. THE SALES REP STATED THE DEVICE WAS DISCARDED BY THE CUSTOMER. 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 8278573 ↗
• MalfunctionJan 18, 2019Fracture; Fracture

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION ACL SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE CUSTOMER'S BIOINTRAFIX SHEATH TRIAL 7-8MM BROKE INTO TWO PIECES. THE SALES REP STATED THAT THE DEVICE BROKE MID SHAFT WHEN TRYING TO REMOVE THE DEVICE. THE SALES REP STATED THAT THE WHERE THE DEVICE BROKE WAS OUTSIDE THE PATIENT. THE SALES REP REPORTED THAT THE SURGEON HAD COMPLETED THE PROCEDURE WITH THE DEVICE BEFORE THE DEVICE FAILURE OCCURRED. THE SALES REP REPORTED THAT THERE WERE NO PATIENT CONSEQUENCES OR DELAYS IN THE CASE. THE SALES REP COULD NOT PROVIDE A LOT NUMBER FOR THE DEVICE BUT STATED THAT THE DEVICE IS APPROXIMATELY FIVE YEARS OLD AND HAS SEEN HEAVY USE IN THE FIELD. 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 8260209 ↗
• MalfunctionJan 17, 2019Fracture; Fracture

  IT WAS REPORTED BY THE SALES REP THAT DURING A DEMONSTRATION, IT WAS OBSERVED THAT THE BIOINTRAFIX 7-8MM SHEATH TRIAL DEVICE BROKE INTO TWO PIECES; AND THAT A GUIDE WIRE COULD NOT PASS THROUGH THE MODULAR DRIVER. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. 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 8257921 ↗
• MalfunctionNov 29, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN ACL RECONSTRUCTION PROCEDURE THE CUSTOMER'S BIOINTRAFIX SMALL SHEATH TRIAL BROKE IN HALF. THE SALES REP STATED THAT THIS BROKE WHILE IT WAS MALLETED ON BY THE SURGEON DURING REMOVAL. THE SALES REP STATED THAT EXCESSIVE FORCE WAS NOT BEING USED. THE SALES REP STATED THAT THE DEVICE WAS REMOVED FROM THE PATIENT AND NO FRAGMENTS WERE CREATED; THERE IS NO NEED FOR SURGICAL INTERVENTION. THE CASE WAS COMPLETED WITH THIS DEVICE WITH NO PATIENT HARM OR DELAY. THE SALES REP COULD NOT PROVIDE A LOT NUMBER. THE DEVICE IS BEING RETURNED FOR EVALUATION. 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 8117231 ↗
• MalfunctionSep 6, 2018Material Separation; Material Separation

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE TOP PART CAME ON THE CUSTOMER'S BIOINTRAFIX SHEATH TRIAL 7-8MM OFF WHEN REMOVING BUT THE BOTTOM PART STAYED IN. THE SALES REP STATED THAT THE SURGEON HAD TO MALLET THE BOTTOM PART OUT. THE SALES REP REPORTED THAT THE SURGEON HAD COMPLETED THE PROCEDURE WITH THE DEVICE BEFORE THE FAILURE OCCURRED. THE SALES REP REPORTED THAT THERE WERE NO PATIENT CONSEQUENCES OR DELAYS IN THE PROCEDURE. THE SALES REP STATED THAT THE DEVICE BROKE OUTSIDE THE PATIENT AND THERE WAS NO DEBRIS IN THE PATIENT. THE SALES REP COULD NOT PROVIDE A LOT NUMBER FOR THE DEVICE BUT STATED THAT THE DEVICE HAS SEEN HEAVY USE IN THE FIELD. 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 7850042 ↗