BIOINTRAFIX 254624Recalls & reported problems

Summary

The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 10886705013210), received between Jul 6, 2018 and Dec 4, 2025 — classified as 7 injuries, 47 malfunctions.

The most frequently reported specific device problem is “Break” (42 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 54 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 4, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT REPAIR PROCEDURE, IT WAS DISCOVERED THAT WHEN THE SCREW ON THE BIOINTRAFIX 7-9MMX30MM TPRSCR DEVICE WAS INSERTED, IT BROKE. ALL THE BROKEN PARTS WERE REMOVED FROM THE PATIENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS TO THE SURGICAL PROCEDURE. IT WAS REPORTED THAT A SPARE DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23720369 ↗
• 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 (B)(6) 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 HEALING AFT

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 21110337 ↗
• MalfunctionOct 28, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE, IT WAS OBSERVED THAT THE BIOINTRAFIX 7-9MMX30MM TPRSCR DEVICE BROKE UPON INSERTION THEN ALL THE BROKEN PIECES WERE REMOVED FROM THE PATIENT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS PATIENT INVOLVEMENT. 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 20545552 ↗
• MalfunctionJul 11, 2024Break; Break

  EVENT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN CHINA THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON(B)(6)2024 WHILE USING THE BIO-INTRAFIX TAPERED SCREW DEVICE AND BIOINTRAFIX TBIAL SH SM 30MM DEVICE THE SHEATH BROKE AND THE ANCHOR AND SHEATH WERE NOT SUCCESSFULLY IMPLANTED TOGETHER. 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 19718786 ↗
• InjuryMar 25, 2024Migration; Migration

  IT WAS REPORTED FROM CHILE WHILE USING AN UNKNOWN IMPLANT DEVICE THAT A PATIENT WHO UNDERWENT SURGERY FOR CHRONIC ANKLE INSTABILITY, WHO UNDERWENT, AMONG OTHER PROCEDURES, A RECONSTRUCTION OF THE ANTERIOR CRUCIATE LIGAMENT WHERE THE GRAFT WAS FIXED WITH THE MILAGRO ADVANCE SCREW IN THE FEMUR AND TIBIA WITH THE BIOINTRAFIX SYSTEM, WAS RE-OPERATED BECAUSE 8 YEARS LATER THE BIOINTRAFIX SCREW WAS EXPELLED FROM THE IMPLANTED AREA, CAUSING AN INFECTION. THE PATIENT UNDERWENT SURGERY AGAIN TO REMOVE THE IMPLANT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 18967477 ↗
• MalfunctionFeb 28, 2024Break; Break

  IT WAS REPORTED BY THE SALES REP IN CHINA THAT DURING A ANTERIOR CRUCIATE LIGAMENT (ACL) REPAIR PROCEDURE PERFORMED ON (B)(6) 2024 IT WAS OBSERVED THAT THE BIOINTRAFIX 7-9MMX30MM TPRSCR ANCHOR DEVICE WAS BROKEN OFF. IT WAS REPORTED THAT ALL BROKEN PARTS WERE REMOVED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18802310 ↗
• MalfunctionAug 18, 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 BIO-INTRAFIX TAPERED SCREW, 7-9 MM X 30 MM 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 17572734 ↗
• MalfunctionAug 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 BIO-INTRAFIX TAPERED SCREW, 7-9 MM X 30 MM 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 17549293 ↗
• MalfunctionApr 10, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  THIS IS REPORT 3 OF 3 FOR (B)(4). IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN CHINA THAT DURING A KNEE PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE SUTURE ON THE TRUESPAN MENISCAL REPAIR SYSTEM PEEK 24 DEGREE DEVICE BROKE OFF WHEN TIGHTENED. CHANGED TO ANOTHER ONE TO CONTINUE THE SURGERY BUT IT DID NOT FIRE AGAIN AFTER THE FIRST FIRING. ACCORDING TO THE REPORT, A FOREIGN MATTER SUCH AS A HAIR WAS FOUND WHEN PACKAGE OF THE BIO-INTRAFIX TAPERED SCREW, 7-9 MM X 30 MM DEVICE WAS OPENED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16709426 ↗
• InjuryFeb 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS REPORT 2 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 16373539 ↗
• MalfunctionDec 16, 2022Break; Break

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY THE SALES REP IN UNITED KINGDOM THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT TWO BIO-INTRAFIX TAPERED SCREW, 7-9 MM X 30 MM DEVICES SNAPPED DURING USE. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED WITH A DELAY OF 10 MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15998652 ↗
• MalfunctionDec 16, 2022Break; Break

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY THE SALES REP IN UNITED KINGDOM THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT TWO BIO-INTRAFIX TAPERED SCREW, 7-9 MM X 30 MM DEVICES SNAPPED DURING USE. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED WITH A DELAY OF 10 MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15998604 ↗
• MalfunctionOct 21, 2022Break; Break

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN CHINA THAT DURING A ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE ANCHOR ON 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 NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15654647 ↗
• MalfunctionAug 17, 2022Break; Break

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN CHINA THAT DURING AN ACL (ANTERIOR CRUCIATE LIGAMENT) RECONSTRUCTION PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE BIO-INTRAFIX TAPERED SCREW, 7-9 MM X 30 MM BROKE OFF. ALL THE BROKEN PARTS WERE REMOVED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15241417 ↗
• InjuryJul 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A REVIEW OF NEW ZEALAND ACL REGISTRY DEPUY IMPLANT REPORT RECEIVED AS PER IIS (B)(4) CONTRACT MILESTONE DELIVERABLE THAT POSTOPERATIVELY TO AN ANTERIOR CRUCIATE LIGAMENT PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE BIO-INTRAFIX TAPERED SCREW, 7-9 MM X 30 MM DEVICE FAILED THAT REQUIRED A REVISION SURGERY. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 14990719 ↗
• MalfunctionMay 9, 2022Crack; Crack

  IT WAS REPORTED BY THE CUSTOMER IN CHINA THAT DURING A KNEE SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE ANCHOR ON THE BIOINTRAFIX 7-9MMX30MM TPRSCR DEVICE WAS CRACKED. 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 14337121 ↗
• MalfunctionDec 14, 2021Break; Break

  IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT THE BIOINTRAFIX 7-9MMX30MM TPRSCR DEVICE WAS BROKEN OFF. ALL THE BROKEN PARTS WERE REMOVED. 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 13005037 ↗
• MalfunctionDec 13, 2021Break; Break

  IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH MENISCAL REPAIR SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT THE BIO-INTRAFIX 7-9MMX30MM TPRSCR ANCHOR DEVICE WAS BROKEN OFF. ALL THE BROKEN PARTS WERE REMOVED. 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 12987256 ↗
• MalfunctionDec 5, 2021Crack; Crack

  IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT THE BIOINTRAFIX (B)(4) TPRSCR ANCHOR DEVICE WAS CRACKED UPON OPENING ITS PACKAGE. 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 12931391 ↗
• InjuryNov 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE CUSTOMER THAT POSTOPERATIVELY TO AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT A PATIENT HAD PAIN AND SOME SWELLING WITH REDNESS OVER TIBIAL INCISION SITE WHERE THE BIOINTRAFIX TBIAL SH LRG 30MM IMPLANT DEVICE WAS INSERTED. SURGEON SAID THERE WAS NO EFFUSION, NO FEVER, CHILLS OR SWEATS. SURGEON ALSO STATED THAT HE DID ASPIRATE AND THERE WAS SOME BLOOD AND MAYBE SOME PUS, BUT WAS NOT SURE. THERE WAS NO REVISION SURGERY OR HARDWARE REMOVAL REQUIRED. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 12728447 ↗
• InjuryJul 21, 2021Break; Break

  THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL RESEARCH REPORT FROM (B)(6) FOR CLINICAL EVIDENCE ON SAFETY AND PERFORMANCE OF A BIOINTRAFIX 7-9MMX30MM TPRSCR IMPLANT DEVICE WHERE A PATIENT REQUIRED REQUIRED RE-OPERATION APPROXIMATELY TWO YEARS AFTER ORIGINAL FOR REMOVAL OF IMPLANT FRAGMENTS. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 12203415 ↗
• InjuryFeb 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE AFFILIATE IN (B)(4) THAT SEVEN DAYS AFTER AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2021 IMPLANTING BIOINTRAFIX 7-9MMX30MM TPRSCR AND BIOINTRAFIX TBIAL SH LRG 30MM DEVICES, IT WAS OBSERVED THAT THE PATIENT HAD A FEVER. IT WAS REPORTED THAT THE PATIENT WAS TREATED WITH ANTI-INFLAMMATORY DRUG FOR ONE WEEK THEN RECOVERED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 11314991 ↗
• MalfunctionSep 18, 2020Break; Break

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE THE BIO-INTRAFIX TIBIAL SHEATH, LARGE AND THE BIO-INTRAFIX TAPERED SCREW, 7-9 MM X 30 MM BROKE DUE TO BAD QUALITY BONE OF THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. THE DEVICES WERE DISCARDED BY THE STAFF. ADDITIONAL INFORMATION PROVIDED BY THE AFFILIATE REPORTED NO BONE FRAGMENTS WERE GENERATED AND ALL BROKEN SHEATH PIECES WERE REMOVED FROM THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10557571 ↗
• MalfunctionSep 2, 2020Break; Break

  IT WAS REPORTED THAT DURING THE SURGERY OF ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION, THE ANCHOR WAS BROKEN OFF, REMOVED ALL THE PIECES. 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 Consequences Or Impact To Patient

  MAUDE report 10481663 ↗
• MalfunctionApr 16, 2020Break; Break

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN ACL PROCEDURE THE BIOINTRAFIX 6-7MMX30MMTPRSCR BROKE OFF, ALL THE PEICES 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 Consequences Or Impact To Patient

  MAUDE report 9970144 ↗