BIOINTRAFIXRecalls & reported problems across all models

We found 2 models of BIOINTRAFIX by Depuy Mitek, LLC in the FDA's device registry (GUDID). Together they are named in 22 adverse event reports in the FDA's MAUDE database, received between May 4, 2018 and Sep 6, 2023 — classified as 22 malfunctions.

The most frequently reported specific device problem is “Break” (14 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported BIOINTRAFIX problems

BIOINTRAFIX models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• BIOINTRAFIX 254651

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  12 reports
• BIOINTRAFIX 254650

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  10 reports

Recent BIOINTRAFIX adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 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 ↗

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