BIOINTRAFIX 254660Recalls & reported problems

Summary

The FDA's MAUDE database contains 56 adverse event reports that list this exact device (DI 10886705013432), received between May 21, 2018 and Jan 30, 2026 — classified as 10 injuries, 46 malfunctions.

The most frequently reported specific device problem is “Break” (41 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 56 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 30, 2026Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT REPAIR (ACL) SURGICAL PROCEDURE IT WAS OBSERVED THAT THE BIOINTFX 6-8MMX30MM TPR SCR 2ND DEVICE SCREW BROKE WHEN INSERTED. ALL BROKEN PARTS WERE REMOVED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24221624 ↗
• MalfunctionJan 23, 2026Break

  IT WAS REPORTED THAT DURING A CRUCIATE LIGAMENT RECONSTRUCTION SURGICAL PROCEDURE, WHEN INSERTING THE BIOINTFX 6-8MMX30MM TPR SCR 2ND TAP SCREW, IT WAS OBSERVED THAT THE SCREW WAS BROKEN IT WAS REPORTED THAT 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 24172760 ↗
• MalfunctionJan 9, 2026Break

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION (ACL) PROCEDURE, IT WAS DISCOVERED THAT TWO BIOINTRAFIX DEVICES BROKE OFF. ALL THE BROKEN PARTS WERE REMOVED. 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 24020524 ↗
• InjuryDec 11, 2025Material Deformation; Migration; Material Deformation; Migration

  REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED THAT FOUR MONTHS AFTER THE INITIAL AUTOGRAFTING OF THE ANTERIOR CRUCIATE LIGAMENT SURGERY PERFORMED ON (B)(6) 2025, USING BIOINTRAFIX TBIAL SH SM 30MM AND BIOINTFX 6-8MMX30MM TPR SCR 2ND DEVICES, THE PATIENT NOTED A COSMETIC DEFECT IN THE PROJECTION OF THE SCREW ON THE TIBIA. IT WAS REPORTED THAT THERE WAS NO PAIN UPON PALPATION, BUT A HARD OBJECT WAS FELT IN THE PROJECTION OF THE SUTURE ON THE TIBIA. ACCORDING TO THE REPORTER, AN MRI WAS PERFORMED ON (B)(6) 2025 OF THE LEFT KNEE JOINT - SCREW MIGRATION FROM THE TIBIAL CANAL WHICH REQUIRED A REVISION SURGERY FOR REMOVAL, HOWEVER THE INTEGRITY OF THE ANTERIOR CRUCIATE LIGAMENT GRAFT WAS INTACT. IT WAS REPORTED THAT THERE WAS NO SOFT TISSUE REACTION OR INFLAMMATION NOTED AND THE PATIENT'S CURRENT CONDITION IS SATISFACTORY, WITH FUTURE MANAGEMENT NOTES AS REHABILITATION AND OBSERVATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23782907 ↗
• MalfunctionDec 10, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT REPAIR (ACL) SURGICAL PROCEDURE IT WAS OBSERVED THAT WHILE USING THE BIOINTFX 6-8MMX30MM TPR SCR 2ND DEVICE WHEN INSERTING THE SCREW, THE SCREW BROKE. ALL THE PIECES WERE REMOVED FROM THE PATIENT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23768821 ↗
• MalfunctionAug 13, 2025Break; Break

  REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING A CRUCIATE LIGAMENT RECONSTRUCTION SURGERY, IT WAS OBSERVED THAT WHILE USING THE BIOINTRAFIX TBIAL SH SM 30MM DEVICE AND THE BIOINTFX 6-8MMX30MM TPR SCR 2ND DEVICE. IT WAS OBSERVED THAT THE ANCHOR DEVICE WAS BROKEN OFF. IT WAS REPORTED THAT ALL THE BROKEN PARTS WERE REMOVED. THE DEVICE WAS CHANGED TO ANOTHER ONE TO CONTINUE THE SURGERY AND THE SAME PROBLEM HAPPENED AGAIN. 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 22792064 ↗
• MalfunctionJul 10, 2025Detachment of Device or Device Component; Migration; Detachment of Device or Device Component; Migration

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT REPAIR SURGERY, IT WAS OBSERVED THAT THE BIOINTFX 6-8MMX30MM TPR SCR 2ND DEVICE SCREW FELL APART AND WAS PULLED OUT FROM THE SHEATH. 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 22466309 ↗
• MalfunctionApr 24, 2024Break; Break

  IT WAS REPORTED BY THE SALES REP IN CHINA THAT DURING AN ACL (ANTERIOR CRUCIATE LIGAMENT) SURGICAL PROCEDURE ON (B)(6) 2024 THE BIOINTFX DEVICE ANCHOR HAD BROKEN OFF. THE USER CHANGED TO TWO OTHERS TO CONTINUE THE SURGERY. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS IS REPORT 3 OF 3 OF THE SAME EVENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19172770 ↗
• MalfunctionApr 24, 2024Break; Break

  IT WAS REPORTED BY THE SALES REP IN CHINA THAT DURING AN ACL (ANTERIOR CRUCIATE LIGAMENT) SURGICAL PROCEDURE ON (B)(6) 2024 THE BIOINTFX DEVICE ANCHOR HAD BROKEN OFF. THE USER CHANGED TO TWO OTHERS TO CONTINUE THE SURGERY. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS IS REPORT 2 OF 3 OF THE SAME EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19172617 ↗
• MalfunctionApr 24, 2024Break; Break

  IT WAS REPORTED BY THE SALES REP IN CHINA THAT DURING AN ACL (ANTERIOR CRUCIATE LIGAMENT) SURGICAL PROCEDURE ON (B)(6) 2024 THE BIOINTFX DEVICE ANCHOR HAD BROKEN OFF. THE USER CHANGED TO TWO OTHERS TO CONTINUE THE SURGERY. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19172389 ↗
• InjuryApr 10, 2024Break; Break

  IT WAS REPORTED FROM CHINA THAT A PATIENT UNDERWENT CRUCIATE LIGAMENT RECONSTRUCTION USING A BIOINTFX 6-8MMX30MM TPR SCR 2ND ANCHOR DEVICE. ABOUT ONE YEAR LATER, IT WAS FOUND THE IMPLANTED SCREW BROKE DURING RE-INSPECTION. IT WAS REPORTED THAT A SECOND SURGERY HAS BEEN COMPLETED IN ANOTHER HOSPITAL TO REMOVE THE BROKEN PRODUCT AND REPLACED IT WITH ANOTHER BRAND PRODUCT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 19077369 ↗
• InjuryDec 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED FROM THE SALES REP IN CHINA THAT DURING AN ANTERIOR CRUCIATE LIGAMENT PROCEDURE ON 11/24/23 THE BIOINTFX 6-8MMX30MM TPR SCR 2ND DEVICE SLIPPED DURING THE SURGERY AND COULDN'T BE TIGHTENED. AFTER REPEATED TIGHTENING ATTEMPTS, THE WOUND WAS CLOSED AND CLOSED THE SURGERY. POST OP, LAXITY WAS NOTED IN POST-OPERATIVE PHYSICAL EXAMINATION. RADIOGRAPHIC EXAMINATION REVEALED THAT THE RIGIDLOOP ADJUSTABLE IMPLANT WAS POSITIONED IN THE MUSCLE LAYER AND FAILED SURGICAL FIXATION. PATIENT UNDERWENT AN ACL REVISION PROCEDURE. THE PATIENT WAS IN STABLE CONDITION NOW. NO FURTHER INFORMATION WAS PROVIDED. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: Unspecified Tissue Injury

  MAUDE report 18310441 ↗
• MalfunctionNov 9, 2023Break; Break

  IT WAS REPORTED BY THE SALES REP IN CHINA THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) REPAIR SURGICAL PROCEDURE ON (B)(6) 2023 IT WAS OBSERVED THAT THE BIOINTFX 6-8MMX30MM TPR SCR 2ND ANCHOR WAS BROKEN OFF, AND THE BIOINTRAFIX TBIAL SH SM 30MM SHEATH PRODUCT WAS TORN AT THE HEAD END AND FOUR RIDGES WERE SCATTERED, MAKING IT IMPOSSIBLE TO ACHIEVE TENDON FIXATION. IT WAS REPORTED THAT ALL BROKEN PARTS WERE REMOVED. IT WAS REPORTED THAT ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS IS REPORT 1 OF 2 FOR THE SAME EVENT IN (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18100731 ↗
• InjurySep 18, 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 AFFILIATE IN RUSSIA THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON AN UNKNOWN DATE IN (B)(6) 2022, TWO BIO-INTRAFIX 6-8 X 30MM TAPERED SCREW DEVICES WERE USED. ACCORDING TO THE REPORT, DURING THE CONTROL EXAMINATION 12 MONTHS AFTER THE OPERATION, NO PATHOLOGY WAS DETECTED. IT WAS REPORTED THAT AFTER A MINOR INJURY IN (B)(6) 2023, DURING SPORTS, THE PATIENT FELT CRUNCH AND SHARP PAIN IN THE UPPER THIRD OF THE LOWER LEG. IT WAS REPORTED THAT AN MRI IN (B)(6) 2023 MARKED OSTEOLYSIS AND CYST AROUND THE SCREW SLEEVE. IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT WAS ADMITTED WITH PAIN IN THE TIBIAL CANAL. IT WAS REPORTED THAT ON (B)(6) 2023, THE REVISION PROCEDURE WAS DONE AS THE PATIENT HAD CYST IN THE TIBIAL CANAL AREA WHICH INCLUDED THE GRAFT BEING WELL-MAINTAINED, THE REMAINS OF THE SLEEVE AND THE SCREW WERE REMOVED, THE BONE PLASTIC OF THE TIBIOFIBULAR CANAL WAS MADE. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Cyst(s); Unspecified Tissue Injury

  MAUDE report 17767549 ↗
• MalfunctionSep 18, 2023Break; Break

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN (B)(6) THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE BIO-INTRAFIX 6-8 X 30MM TAPERED SCREW 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 17765219 ↗
• InjurySep 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THROUGH HEALTH AUTHORITY IN CHINA THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2022, A BIO-INTRAFIX 6-8 X 30MM TAPERED SCREW DEVICE WAS USED. ACCORDING TO THE REPORT, THREE MONTHS AFTER SURGERY, THE PATIENT UNDERWENT JOINT CLEARANCE SURGERY IN HOSPITAL DUE TO POOR WOUND HEALING AND CHANGED DRESSING, BUT NO SIGNIFICANT IMPROVEMENT WAS OBSERVED. IT WAS REPORTED THAT AFTER 11 MONTHS OF SURGERY, THE PATIENT ONCE AGAIN EXPERIENCED POOR WOUND HEALING AND POOR DRESSING CHANGE. IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED AND UNDERWENT JOINT CLEANING SURGERY, AND THEIR CONDITION IMPROVED AND THEY WERE DISCHARGED. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Impaired Healing

  MAUDE report 17731378 ↗
• 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 6-8 X 30MM TAPERED SCREW 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 17549826 ↗
• MalfunctionAug 14, 2023Break; Break

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN CHINA THAT DURING AN ANTERIOR CRUCIATE RECONSTRUCTION PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE SUTURE ON THE BIO-INTRAFIX 6-8 X 30MM TAPERED SCREW 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 17544663 ↗
• MalfunctionAug 14, 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 6-8 X 30MM TAPERED SCREW 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 17543906 ↗
• InjuryJul 12, 2023Break; Break

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN CHINA THAT A PATIENT UNDERWENT AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2022 USING A BIO-INTRAFIX 6-8 X 30MM TAPERED SCREW DEVICE TO FIX THE GRAFT ON THE TIBIAL SIDE. ACCORDING TO THE REPORT, AFTER THE OPERATION, PROPHYLACTIC ANTIBIOTICS WERE USED. IT WAS REPORTED THAT MORE THAN ONE YEAR AFTER THE OPERATION, THE PATIENT BEGAN TO EXPERIENCE EXUDATION AT THE WOUND ON THE TIBIAL SIDE. MRI SHOWED THAT THE SCREW WAS BROKEN. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 17310972 ↗
• InjuryJul 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN CHINA THAT A PATIENT UNDERWENT AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE OF THE LEFT KNEE. ACCORDING TO THE REPORT, THE CONDITION IMPROVED TWO DAYS AFTER THE SURGERY AND WAS DISCHARGED. IT WAS REPORTED THAT AFTER THREE MONTHS, THE PATIENT GRADUALLY DEVELOPED SYMPTOMS OF LEFT KNEE JOINT SWELLING, PAIN, AND DISCOMFORT. IT WAS REPORTED THAT THE PATIENT RECEIVED REHABILITATION TREATMENT IN THE HOSPITAL. IT WAS REPORTED THAT ABOUT 111 DAYS AFTER THE OPERATION, THE PATIENT FELT THAT THE SWELLING, PAIN AND DISCOMFORT OF THE LEFT KNEE JOINT WERE AGGRAVATED. IT WAS REPORTED THAT FOR FURTHER TREATMENT, CT EXAMINATION SHOWED THAT THE ACL OF THE LEFT KNEE JOINT CHANGED AFTER THE OPERATION, AND BONE ENLARGEMENT WAS SEEN IN THE TIBIA AND FEMORAL CANAL. IT WAS REPORTED THAT AFTER COMING TO THE HOSPITAL FOR TREATMENT, THE DIAGNOSIS OF INFECTION AFTER THE RECONSTRUCTION OF THE ANTERIOR CRUCIATE LIGAMENT OF THE LEFT KNEE JOINT WAS INCLUDED IN OUR DEPARTMENT. ITW WAS REPORTED THAT A LEFT KNEE ARTHROSCOPY WAS USED TO CHECK THE WOUND AND REMOVE THE INTERNAL FIXATION UNDER GENERAL ANESTHESIA 114 DAYS AFTER THE OPERATION. IT WAS REPORTED THAT A

  Patient problems: Unspecified Infection

  MAUDE report 17301914 ↗
• InjuryJul 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN CHINA THAT THE PATIENT UNDERWENT AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE USING A BIO-INTRAFIX 6-8 X 30MM TAPERED SCREW DEVICE TO FIX THE GRAFT ON THE TIBIAL SIDE. ACCORDING TO THE REPORT, AFTER THE OPERATION, PROPHYLACTIC ANTIBIOTICS WERE USED. IT WAS REPORTED THAT AFTER THE OPERATION, THE PATIENT HAD REPEATED LOCAL BLEEDING OF THE WOUND, DISINFECTION AND DRESSING CHANGE DID NOT IMPROVE, AND THE SECOND DEBRIDEMENT WAS PERFORMED. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Impaired Healing

  MAUDE report 17301910 ↗
• InjuryApr 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN CHINA THAT BEFORE THE ARTHROSCOPIC CLEANING OF THE LEFT KNEE FOR ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH LATERAL MENISCUS SUTURE AND PRP IMPLANTATION, 1.5 INTRAVENOUS DROPS OF CEFUROXIME SODIUM WERE GIVEN. ACCORDING TO THE REPORT, THERE WAS NOT MUCH BLEEDING DURING THE OPERATION, AND NO BLOOD TRANSFUSION WAS PERFORMED. IT WAS REPORTED THAT THE INTRAOPERATIVE INFUSION WAS 1000M1. IT WAS REPORTED THAT AFTER THE OPERATION, THE PATIENT RETURNED TO THE WARD SAFELY, AND CEFUROXIME SODIUM WAS GIVEN A SENSE OF PREVENTION AND CONTINUED TO BE USED UNTIL THE FIRST DAY AFTER THE OPERATION. IT WAS REPORTED THAT THE DRESSING WAS CHANGED 3 DAYS AFTER THE OPERATION, AND NO ABNORMALITY WAS FOUND IN THE WOUND. IT WAS REPORTED THAT THE PATIENT WAS ARRANGED TO BE DISCHARGED. IT WAS REPORTED THAT AFTER TWO WEEKS OF DISCHARGE, THE LOCAL HOSPITAL CHANGED THE DRESSING AND REMOVED THE STITCHES. IT WAS REPORTED THAT THE WOUND HAD SECRETIONS, WITHOUT REDNESS OR SWELLING, AND THE DRESSING WAS CHANGED. IT WAS REPORTED THAT THE WOUND ON THE LEFT TIBIAL TUBERCLE DID NOT HEAL, WITH YELLOW SECRETIONS. IT WAS REPORTED THAT AFTER 68 DAYS OF SURGERY, THE PATIENT

  Patient problems: Fluid Discharge; Impaired Healing

  MAUDE report 16685599 ↗
• InjuryApr 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN CHINA THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2020, A BIO-INTRAFIX 6-8 X 30MM TAPERED SCREW DEVICE WAS USED. ACCORDING TO THE REPORT, AFTER 731 DAYS OF SURGERY, THERE WAS REPEATED EXUDATION OF GRAYISH WHITE FLUID FROM THE LEFT KNEE WOUND, WHICH WAS TREATED WITH DRESSING CHANGE. THE EFFECT WAS NOT SATISFACTORY, AND DEBRIDEMENT WAS PERFORMED. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Fluid Discharge

  MAUDE report 16682430 ↗
• MalfunctionMar 2, 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 6-8 X 30MM TAPERED SCREW DEVICE WAS BROKEN 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 16467792 ↗