BIOINTRAFIX 254628Recalls & reported problems

Summary

The FDA's MAUDE database contains 91 adverse event reports that list this exact device (DI 10886705013241), received between Jun 18, 2018 and Sep 19, 2025 — classified as 5 injuries, 86 malfunctions.

The most frequently reported specific device problem is “Break” (69 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 25 most recent of 91 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 19, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) SURGICAL PROCEDURE IT WAS OBSERVED THAT THE BIOINTRAFIX TBIAL SH LRG 30MM SHEATH DEVICE WAS BROKEN. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23094351 ↗
• MalfunctionJul 7, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT REPAIR (ACL) SURGICAL PROCEDURE IT WAS OBSERVED THAT WHILE USING THE BIOINTRAFIX TBIAL SH LRG 30MM DEVICE AND THE MILAGRO INSCR SMALL SIZE 6X23 DEVICE ANCHOR WAS BROKEN OFF. ALL BROKEN PARTS WERE REMOVED. THE USER CHANGED TO ANOTHER DEVICE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 2 OF (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22416241 ↗
• MalfunctionMar 26, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) REPAIR PROCEDURE, THE BIOINTRAFIX TBIAL SH LRG 30MM SHEATH WAS BROKEN OFF. IT WAS REPORTED THAT ALL BROKEN PARTS WERE REMOVED. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21700108 ↗
• MalfunctionFeb 20, 2025Break; Break

  IT WAS REPORTED THAT DURING A CRUCIATE LIGAMENT RECONSTRUCTION SURGICAL PROCEDURE THE BIOINTRAFIX TBIAL DEVICE ANCHOR WAS BROKEN OFF. AFTER IMPLANTATION THE ANCHOR SHEATH DEHISCENCE. ALL BROKEN PARTS WERE REMOVED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21425849 ↗
• InjuryJan 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING ANTERIOR CRUCIATE LIGAMENT REPAIR SURGERY, THE PATIENT EXPERIENCED POST-OPERATIVE INFLAMMATION. IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO XI'AN RED CROSS HOSPITAL 216 DAYS AGO DUE TO "LEFT KNEE JOINT PAIN AND DISCOMFORT CAUSED BY SPRAIN FOR ONE MONTH". ACCORDING TO THE REPORTER, UNDER GENERAL ANESTHESIA COMBINED WITH NERVE BLOCK, THE PATIENT UNDERWENT "LEFT KNEE ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY AND ARTHROSCOPIC MENISCUS SHAPING SURGERY AND ARTHROSCOPIC KNEE SYNOVECTOMY AND TENDON EXCISION SURGERY AND JOINT THERAPEUTIC SUBSTANCE INJECTION". IT WAS REPORTED THAT THE ANTERIOR CRUCIATE LIGAMENT REPAIR SYSTEM WAS USED DURING THE SURGERY, AND THE SURGERY WENT SMOOTHLY HOWEVER POSTOPERATIVE CT SCAN SHOWED FIRM INTERNAL FIXATION. ACCORDING TO THE REPORTER, AFTER SIX WEEKS OF SURGERY, THE PATIENT EXPERIENCED POOR WOUND HEALING AND WAS ADMITTED TO THE HOSPITAL 166 DAYS AGO WITH THE COMPLAINT OF "POOR WOUND HEALING AFTER 6 WEEKS OF LEFT ANTERIOR CRUCIATE LIGAMENT REVISION SURGERY AND ONE WEEK OF POOR WOUND HEALING". IT WAS REPORTED THAT UNDER GENERAL ANESTHESIA, THE PATIENT UNDERWENT "DEBRIDEMENT AND VSD DRAINAGE SURGERY FOR POOR WOUND HE

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 21110370 ↗
• MalfunctionFeb 8, 2024Break; Break

  IT WAS REPORTED BY THE SALES REP IN CHINA THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2024 THE BIOINTRAFIX TBIAL DEVICE WAS BROKEN. ALL THE PIECES WERE REMOVED FROM THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18672394 ↗
• MalfunctionFeb 8, 2024Break; Break

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN CHINA THAT DURING AN ANTERIOR CRUCIATE LIGAMENT REPAIR PROCEDURE ON (B)(6)2024, IT WAS OBSERVED THAT THE BIO-INTRAFIX TIBIAL SHEATH - LARGE DEVICE SHEATH WAS BROKEN OFF. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 18666327 ↗
• MalfunctionJan 31, 2024Break; Break

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN CHINA THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2024, IT WAS OBSERVED THAT THE SHEATH ON THE BIOINTRAFIX TBIAL SH LRG 30MM DEVICE WAS BROKEN OFF, THEN REMOVED ALL THE BROKEN PARTS. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 18618911 ↗
• MalfunctionDec 29, 2023Break; Break

  IT WAS REPORTED BY THE SALES REP IN CHINA THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) REPAIR PROCEDURE PERFORMED ON (B)(6) 2023, WHEN THE PHYSICIAN IMPLANTED THE BIOINTRAFIX "TIBIAL" SH LRG 30MM SHEATH INTO THE BODY, THE SHEATH BROKE INTO SEVERAL PIECES. THE SURGEON CHANGED TO ANOTHER BIOINTRAFIX "TIBIAL" SH LRG 30MM SHEATH AND THE SAME PROBLEM OCCURRED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 2 OF 2 FOR THE SAME EVENT IN (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18418415 ↗
• MalfunctionDec 29, 2023Break; Break

  IT WAS REPORTED BY THE SALES REP IN CHINA THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) REPAIR PROCEDURE PERFORMED ON (B)(6) 2023, WHEN THE PHYSICIAN IMPLANTED THE BIOINTRAFIX "TIBIAL" SH LRG 30MM SHEATH INTO THE BODY, THE SHEATH BROKE INTO SEVERAL PIECES. THE SURGEON CHANGED TO ANOTHER BIOINTRAFIX "TIBIAL" SH LRG 30MM SHEATH AND THE SAME PROBLEM OCCURRED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 2 FOR THE SAME EVENT IN (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18418383 ↗
• MalfunctionNov 15, 2023Break; Break

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN CHINA THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE BIOINTRAFIX TBIAL SH LRG 30MM DEVICE WAS BROKEN OFF, THEN REMOVED ALL THE BROKEN PARTS. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 18143077 ↗
• MalfunctionNov 15, 2023Break; Break

  IT WAS REPORTED BY THE SALES REP IN CHINA THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2023 THE BIOINTRAFIX TBIAL SH LRG 30MM DEVICE SHEATH WAS BROKEN OFF. ALL THE BROKEN PARTS WERE REMOVED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18142725 ↗
• MalfunctionNov 15, 2023Break; Break

  THIS IS REPORT 2 OF 3 FOR (B)(4). IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN CHINA THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE BIOINTRAFIX TBIAL SH LRG 30MM DEVICE WAS BROKEN OFF, THEN REMOVED ALL THE BROKEN PARTS. CHANGED TO ANOTHER TWO TO CONTINUE THE SURGERY BUT THE SAME PROBLEM HAPPENED AGAIN. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 18140870 ↗
• MalfunctionNov 15, 2023Break; Break

  THIS IS REPORT 1 OF 3 FOR (B)(4). IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN CHINA THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE BIOINTRAFIX TBIAL SH LRG 30MM DEVICE WAS BROKEN OFF, THEN REMOVED ALL THE BROKEN PARTS. CHANGED TO ANOTHER TWO TO CONTINUE THE SURGERY BUT THE SAME PROBLEM HAPPENED AGAIN. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 18140864 ↗
• MalfunctionNov 15, 2023Break; Break

  THIS IS REPORT 3 OF 3 FOR PC-(B)(4). IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN CHINA THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON 10/1/2023, IT WAS OBSERVED THAT THE BIOINTRAFIX TBIAL SH LRG 30MM DEVICE WAS BROKEN OFF, THEN REMOVED ALL THE BROKEN PARTS. CHANGED TO ANOTHER TWO TO CONTINUE THE SURGERY BUT THE SAME PROBLEM HAPPENED AGAIN. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 18140846 ↗
• MalfunctionAug 31, 2023Break; Break

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN CHINA THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE SHEATH ON THE BIO-INTRAFIX TIBIAL SHEATH - LARGE DEVICE WAS BROKEN OFF UPON INSERTION OF THE ANCHOR, THEN REMOVED ALL THE BROKEN PARTS. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 17664474 ↗
• MalfunctionAug 30, 2023Break; Break

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN CHINA THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE SHEATH ON THE BIO-INTRAFIX TIBIAL SHEATH - LARGE DEVICE WAS BROKEN OFF, THEN REMOVED ALL THE BROKEN PARTS. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 17651391 ↗
• MalfunctionAug 28, 2023Break; Break

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN CHINA THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE BIO-INTRAFIX TIBIAL SHEATH - LARGE DEVICE WAS BROKEN OFF, THEN REMOVED ALL THE BROKEN PARTS. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 17631958 ↗
• MalfunctionAug 11, 2023Break; Break

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN CHINA THAT DURING A ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE BIO-INTRAFIX TIBIAL SHEATH - LARGE DEVICE WAS BROKEN OFF, THEN REMOVED ALL THE BROKEN PARTS. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 17510117 ↗
• MalfunctionJul 25, 2023Break; Break

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN CHINA THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE BIO-INTRAFIX TIBIAL SHEATH - LARGE DEVICE BROKE OFF. REMOVED ALL THE BROKEN PARTS AND ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 17390998 ↗
• MalfunctionApr 19, 2023Break; Break

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN CHINA THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE BIO-INTRAFIX TIBIAL SHEATH - LARGE DEVICE WAS BROKEN. REMOVED ALL THE BROKEN PARTS. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 16770874 ↗
• InjuryFeb 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY THE SALES REP IN CHINA THAT A PATIENT UNDERWENT AN ARTHROSCOPIC RECONSTRUCTION PROCEDURE FOR ANTERIOR CRUCIATE LIGAMENT INJURY ON (B)(6) 2022; AND WAS IMPLANTED WITH TWO BIOINTRAFIX IMPLANTS; BIO-INTRAFIX TIBIAL SHEATH - LARGE DEVICE AND BIO-INTRAFIX TAPERED SCREW, 7-9 MM X 30 MM DEVICE. ACCORDING TO THE REPORT, THE PATIENT DEVELOPED REJECTION WITH PERSISTENT LOW-GRADE FEVER THREE MONTHS AFTER THE INITIAL PROCEDURE. IT WAS FURTHER REPORTED THAT A SECOND SURGERY WAS UNDERGONE TO REMOVE THE IMPLANTS ON (B)(6) 2023. AND THE PEEK IMPLANTS WERE REPLACED FOR IMPLANTING. IT WAS REPORTED THAT THE PATIENT WAS IN STABLE CONDITION NOW. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body Reaction; Inflammation

  MAUDE report 16373532 ↗
• MalfunctionNov 22, 2022Break; Break

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN CHINA THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY ON 10/27/2022, IT WAS OBSERVED THAT THE BIO-INTRAFIX TIBIAL SHEATH - LARGE DEVICE WAS BROKEN OFF. REMOVED ALL THE BROKEN PARTS. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15848248 ↗
• MalfunctionNov 22, 2022Break; Break

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN CHINA THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE BIO-INTRAFIX TIBIAL SHEATH - LARGE DEVICE WAS BROKEN OFF. REMOVED ALL THE BROKEN PARTS. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15848105 ↗
• MalfunctionNov 22, 2022Break; Break

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN CHINA THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE BIO-INTRAFIX TIBIAL SHEATH - LARGE WAS BROKEN OFF. REMOVED ALL THE BROKEN PARTS. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15847995 ↗