BIOINTRAFIX 254651Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10886705013425), received between May 4, 2018 and Sep 6, 2023 — classified as 12 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 6, 2023Break; Break

  IT WAS REPORTED BY SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) REPAIR PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE BIOINTRAFIX TRIAL SPLIT IN HALF AT THE JUNCTURE UPON REMOVAL. IT WAS UNKNOWN IF AND HOW THE PROCEDURE WAS COMPLETED. 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 17692173 ↗
• MalfunctionDec 18, 2022Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED BY THE SALES REP IN ITALY THAT PREOPERATIVELY TO AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE BIOINTRAFIX TRIAL DEVICE WAS WORN OUT AND MAYBE BROKEN. 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 16001594 ↗
• MalfunctionJan 6, 2022Break; Break

  IT WAS REPORTED BY THE CUSTOMER THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT THE BIOINTRAFIX SHEATHTRIAL 9MM BROKE AT THE WELD WHILE USING THE MALLET. ALL THE REMAINING PIECES WERE PULLED BY PLIERS. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. 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 13178789 ↗
• MalfunctionSep 3, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT AFTER AN ANTERIOR CRUCIATE LIGAMENT REPAIR IT WAS NOTICED THAT THE BIOINTRAFIX TRIAL CAME APART. THE PROCEDURE WAS COMPLETED BY USING THE SAME DEVICE. NO PATIENT CONSEQUENCES OR SURGICAL DELAY. THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10487738 ↗
• MalfunctionDec 11, 2019Break; Break

  IT WAS REPORTED BY THE AFFILIATE VIA PHONE THAT DURING AN UNKNOWN PROCEDURE THE BIOINTRAFIX SHEATHTRIAL 9 MM EA WAS BROKEN AND THE BIOINTRAFIX 7-8 MM 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 9452316 ↗
• MalfunctionFeb 20, 2019Break; Break

  IT WAS REPORTED BY THE AFFILIATE VIA EMAIL THAT THE CALIBRATOR BROKE ON THE DEVICE. THE PROCEDURE WAS COMPLETED WITH NO PATIENT HARM OR TIME DELAY TO THE CASE. THE AFFILIATE REPORTS THAT THERE IS NO FURTHER INFORMATION AVAILABLE. ADDITIONAL INFORMATION RECEIVED FROM THE AFFILIATE ON (B)(4) 2019 REPORTING THAT LOT NUMBER OF THE DEVICE IS UNKNOWN. THE AFFILIATE ALSO STATED THAT THE DATE OF THE EVENT WAS (B)(6) 2019. IT WAS ALSO REPORTED THAT THE DEVICE BROKE DURING THE PROCEDURE AND THE SURGEON USED A DIFFERENT MATERIAL TO COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8355964 ↗
• MalfunctionJan 30, 2019Break; Break

  IT WAS REPORTED DURING AN ACL REPAIR THE BIOINTRAFIX SHEATH TRIAL 9 MM BROKE AT THE LOWER WELD. THE PROCEDURE THE WAS COMPLETED USING THE DEVICE AS THE BREAKAGE OCCURRED AT THE END OF THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE OR SURGICAL DELAY. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8288467 ↗
• MalfunctionJan 30, 2019Fracture; Fracture

  IT WAS REPORTED THAT DURING A KNEE PROCEDURE THE CUSTOMER'S BIO INTRAFIX 9MM TRIAL INSTRUMENT BROKE IN HALF UP NEAR THE SHAFT INSERTER. NOTHING BROKE IN THE PATIENT. NO DEBRIS IN 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 8288407 ↗
• MalfunctionJan 17, 2019Fracture; Fracture

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE BIOINTRAFIX SHEATHTRIAL 9MM *EA DEVICE BROKE INTO TWO PIECES IN THE MIDDLE. ACCORDING TO THE REPORTER, THE EVENT OCCURRED WHEN THE SURGEON WAS REMOVING THE DEVICE. THE SALES REP STATED THAT THE SURGEON REMOVED THE OTHER HALF BY USING A MALLET ON THE PIECE WITH NO ISSUES. THE SALES REP STATED THAT WHERE THE DEVICE BROKE IS 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 BUT THERE WAS A MINUTE DELAY IN THE CASE. THE SALES REP COULD NOT PROVIDE A LOT NUMBER FOR THE DEVICE BUT STATED THAT THE DEVICE IS APPROXIMATELY TWO YEARS OLD. THE DEVICE WILL BE RETURNING 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 8257336 ↗
• MalfunctionJan 16, 2019Fracture; Fracture

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE BIOINTRAFIX SHEATHTRIAL 9MM *EA DEVICE BROKE WHEN IMPACTED WITH THE HAMMER. THEY WERE ABLE TO CONTINUE WITH THE PROCEDURE WITHOUT THE INSTRUMENT. PRODUCT SPECIALIST WAS NOT PRESENT DURING THE CASE. NOTHING FELL INTO THE PATIENT. PATIENT WAS FINE POST-SURGERY. NO DELAY IN SURGERY. NO ADVERSE EVENT TO PATIENT. 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: Not Applicable

  MAUDE report 8253373 ↗
• MalfunctionAug 8, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) REPAIR SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE BIOINTRAFIX SHEATH TRIAL, 9 MM SNAPPED AND SPLIT THE T-HANDLE. THE SURGEON USED ANOTHER LIKE DEVICE TO COMPLETE THE PROCEDURE WITH ANOTHER LIKE DEVICE, NO DELAY AND NO CONSEQUENCES. 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 7763984 ↗
• MalfunctionMay 4, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP THAT THE CUSTOMER'S BIO INTRAFIX SHEATH BROKE AT THE SHAFT WHILE USING THE MALLET ON IT DURING AN ACL PROCEDURE. THE CASE WAS COMPLETED BY REMOVING THE INSTRUMENT AND USING ANOTHER LIKE DEVICE. THERE WERE NO PATIENT CONSEQUENCES OR DELAYS. THE SALES REP WAS NOT PRESENT DURING THE CASE AND COULD NOT PROVIDE ANY MORE DETAILS. THE DEVICE IS BEING RETURNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7486488 ↗