INTRAFIX 254808Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 10886705026753), received between May 31, 2018 and Sep 10, 2026 — classified as 2 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Break” (24 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 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2026Break

  It was reported that during a Knee arthrometer collateral ligament repair surgical procedure when inserting the INTRAFX ADVBR (b)(6)W/LGSHTH screw device, it was observed that the screw was broken off. It was reported that all pieces were removed from the patient. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50713047 ↗
• MalfunctionSep 1, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50549114 ↗
• MalfunctionAug 4, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50131915 ↗
• MalfunctionJun 12, 2026Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ANTERIOR CRUCIATE LIGAMENT REPAIR PROCEDURE THE INTRAFX ADVBR SCW9X30 W/LGSHTH DEVICE BROKE. ALL BROKEN PARTS WERE REMOVED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25488056 ↗
• MalfunctionMar 30, 2026Break

  THIS IS REPORT 2 OF 4 OF (B)(4). IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT AND MENISCUS REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT WHILE USING THE 3X TRUESPAN 24 DEGREE PEEK DEVICES AND INTRAFX ADVBR SCW9X30 W/LGSHTH DEVICE COULD NOT FIRE AND THE SCREW BROKE OFF. THE USER CHANGED TO ANOTHER TWO TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. ANOTHER DEVICE OF THE SAME PRODUCT CODE WAS USED TO CONTINUE THE SURGERY AND WHEN INSERTING THE SCREW, THE SCREW WAS BROKEN, ALL THE PIECES WERE REMOVED. ANOTHER SCREW OF THE SAME PRODUCT CODE WAS USED TO COMPLETE THE SURGERY. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. 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 24736627 ↗
• MalfunctionMar 25, 2026Break

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE IT WAS OBSERVED THAT WHILE USING THE INTRAFIX DEVICE, THE SHEATH OF INTRAFIX ADVANCE WAS BROKEN BEFORE THE SURGEON INSERTED THE SCREW WHEN THE SURGEON WAS PERFORMING PCL RECONSTRUCTION. FRAGMENTS WERE GENERATED AND WERE REMOVED WITHOUT INTERVENTION. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2026. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24690966 ↗
• InjuryDec 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  POST-OP INFLAMMATION. THIS CASE IS FROM THE HEALTH AUTHORITY. THE PATIENT UNDERWENT COMPREHENSIVE RELEVANT EXAMINATIONS AND TESTS UPON ADMISSION, AND AFTER EXCLUDING SURGICAL CONTRAINDICATIONS, SURGERY WAS PERFORMED ON THE SAME DAY. AFTER SURGERY, KNEE JOINT STIFFNESS AND POOR SKIN WOUND HEALING WERE OBSERVED, AND HOSPITALIZATION WAS REQUIRED. SURGERY WAS PERFORMED TWO AND THREE MONTHS LATER, RESPECTIVELY. TWO MONTHS LATER, DURING THE SURGERY, INACTIVATED TISSUE WAS TAKEN AND SENT FOR GENERAL BACTERIAL CULTURE (RESULTS WERE NOT DETECTED). ONE WEEK AFTER THE SURGERY, THE VSD DEVICE WAS REMOVED AND THE SURGERY WAS PERFORMED AGAIN. DURING THE SURGERY, DAMAGED TISSUE WAS TAKEN AND SENT FOR GENERAL BACTERIAL CULTURE RESULTS. AFTER X DAYS, THE RESULTS SHOWED THAT STAPHYLOCOCCUS AUREUS SUBSP. HOMINIS (MULTIDRUG-RESISTANT). AFTER CONSULTATION WITH THE CLINICAL PHARMACY DEPARTMENT, VANCOMYCIN 1.0G, IVGTT, Q12H WERE GIVEN SLOWLY INTRAVENOUSLY. AFTER CURRENT MEDICATION, THE PATIENT'S INFECTION INDICATORS DECREASED, LIVER AND KIDNEY FUNCTION WERE GOOD, AND THE WOUND AND GENERAL CONDITION RECOVERED WELL.

  Patient problems: Unspecified Infection

  MAUDE report 23863045 ↗
• MalfunctionDec 22, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THE TWO (X2) OMNISPAN MENISCAL REPAIR 27DEG DEVICES WERE BEING USED WHEN THEY COULD NOT FIRE. WHEN INSERT THE SCREW, THE SCREW'S WAS BROKEN, ALL THE PIECES WERE REMOVED FROM THE PATIENT. ANOTHER DEVICES WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 2 OF 2 FOR THE SAME EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23862868 ↗
• MalfunctionDec 2, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT REPAIR SURGERY, IT WAS OBSERVED THAT THE INTRAFX ADVBR SCW9X30 W/LGSHTH DEVICE SHEATH WAS DAMAGED WHEN SCREWING IN THE SCREW. 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 23691505 ↗
• MalfunctionSep 30, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) SURGICAL PROCEDURE IT WAS OBSERVED THAT THE INTRAFX ADVBR SCW9X30 W/LGSHTH DEVICE ANCHOR WAS DETACHED AFTER IMPLANTATION. 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 23186667 ↗
• MalfunctionSep 12, 2025Break; Crack; Break; Crack

  IT WAS REPORTED THAT DURING A CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE, THE ANCHOR WAS FOUND TO BE INTACT AFTER OPENING THE PACKAGE OF THE INTRAFX ADVBR SCW9X30 W/LGSHTH DEVICE. HOWEVER, A CRACK WAS OBSERVED AT THE FRONT END OF THE SHEATH. THE SURGERY CONTINUED, BUT THE SHEATH BROKE AFTER IMPLANTATION. 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 23038418 ↗
• MalfunctionAug 18, 2025Break; Break

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT REPAIR PROCEDURE, IT WAS DISCOVERED THAT THE ANCHORS ON THE INTRAFX ADVBR SCW9X30 W/LGSHTH DEVICE AND GRYPHON P BR DS ANCHOR W/OC DEVICE 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 22832300 ↗
• MalfunctionJul 28, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT THE INTRAFX ADVBR SCW9X30 W/LGSHTH 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 COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22628075 ↗
• MalfunctionJun 26, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGICAL PROCEDURE WHILE USING THE INTRAFX ADVBR SCW9X30 W/LGSHTH DEVICE IT WAS OBSERVED THAT THE ANCHOR WAS BROKEN OFF. 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 22338827 ↗
• MalfunctionJun 2, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) REPAIR PROCEDURE, IT WAS OBSERVED THAT THE INTRAFX ADVBR SCW9X30 W/LGSHTH ANCHOR DEVICE 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 22124774 ↗
• MalfunctionFeb 19, 2025Break; Break

  IT WAS REPORTED THAT DURING A LIGAMENT RECONSTRUCTION PROCEDURE, IT WAS DISCOVERED THAT THE ANCHOR ON THE INTRAFX ADVBR SCW9X30 W/LGSHTH DEVICE 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 WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN (B)(6) 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21411627 ↗
• MalfunctionJan 31, 2025Break; Break

  IT WAS REPORTED THAT DURING A CRUCIATE LIGAMENT REPAIR SURGICAL PROCEDURE THE INTRAFX ADVBR SCW9X30 W/LGSHTH DEVICE DID NOT FUNCTION AND THE SCREW BROKE. AFTER CONNECTING WITH THE GENERATOR, THE DEVICE DID NOT FUNCTION AT ALL AND THE SCREEN DID NOT SHOW ANY ALERT CODE. WHEN THE SCREW WAS INSERTED, THE SCREW WAS BROKEN, ALL THE PIECES WERE REMOVED FROM THE PATIENT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTS OF 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 21283463 ↗
• MalfunctionNov 5, 2024Break; Break

  IT WAS REPORTED BY THE SALES REP IN CHINA THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2024 THE INTRAFX ADVBR SCW9X30 W/LGSHTH DEVICE SHEATH WAS BROKEN. 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 20608497 ↗
• MalfunctionOct 19, 2023Difficult to Advance; Difficult to Advance

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGICAL PROCEDURE ON (B)(6) 2023 THE INTRAFX ADVBR SCW9X30 W/LGSHTH DEVICE WHILE INSERTING THE SHEATH KEPT SLIDING WITH THE SCREW, NEVER ABLE TO ENTER THE CORTEX OF THE TIBIA. THE SHEATH WAS REMOVED FROM THE SCREW, A NEW SHEATH 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 17966254 ↗
• MalfunctionOct 2, 2023Break; Break

  IT WAS REPORTED BY SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) REPAIR PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE INTRAFIX ADVANCE BR SCREW 9 X 30 MM W/LG SHEATH DEVICE BROKE UPON INSERTION; AND THEREFORE, COULD NOT BE SCREWED. ACCORDING TO THE REPORT, BOTH THE BROKEN SHEATH AND SCREW 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 17856932 ↗
• MalfunctionMar 15, 2021Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE LOWER LEFT QUADRANT ON THE INTRAFIX ADVANCE BR SCREW 9 X 30 MM W/LG SHEATH DEVICE BROKE DURING INSERTION. ANOTHER LIKE DEVICE USED TO COMPLETE THE PROCEDURE WITHOUT DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11486830 ↗
• MalfunctionMar 15, 2021Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE LOWER LEFT QUADRANT ON THE INTRAFIX ADVANCE BR SCREW 9 X 30 MM W/LG SHEATH DEVICE BROKE DURING INSERTION. ANOTHER LIKE DEVICE USED TO COMPLETE THE PROCEDURE WITHOUT DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11486690 ↗
• MalfunctionOct 19, 2020Break; Break

  IT WAS REPORTED BY THE SALES REP VIA EMAIL THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE THE SURGEON USED THE APPROPRIATE TECHNIQUES TO PREP THE GRAFT, ATTACH TO THE TENSIONER AND IMPLANT THE INTRAFIX ADVANCE LARGE 9X30MM BR. THE SHEATH WAS INSERTED WITH THE PROPER SHEATH INSERTION INSTRUMENT. WHEN THEY WENT TO INSERT THE SCREW THE SHEATH CRACKED AND BROKE IN SEVERAL PLACES BEFORE THE SCREW WAS FULLY SEATED. THE BROKEN SHEATH STARTED TURNING WITH THE SCREW AND PREVENTED THE SCREW FROM ADVANCING ANY FURTHER. THE SURGEON BACKED THE SCREW OUT, THEN RETRIEVED THE PIECES OF THE BROKEN SHEATH. GAVE THE AREA A GOOD WASH OUT AND THEN SUCCESSFULLY IMPLANTED A SMALLER SIZE INTRAFIX ADVANCE SHEATH AND SCREW. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. THE DEVICE WAS DISCARDED BY THE STAFF.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10701863 ↗
• MalfunctionSep 11, 2019Break; Break

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN ACL PROCEDURE WHEN OPENING THE PACKAGE TO THEIR INTRAFIX ADVANCE BR SCREW 9X30MM WITH LARGE SHEATH, THE PROXIMAL END OF THE SHEATH SEEMED TO BE WIDER. WHEN THE SURGEON WENT TO INSERT THE SHEATH, IT SPLIT INTO PIECES. THE SALES REP CONFIRMED THAT THE PIECES WERE REMOVED AND NO DEBRIS WAS LEFT IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER LIKE DEVICE USING THE SAME BONE HOLE WITH NO PATIENT HARM BUT THERE WAS A FIVE MINUTE SURGICAL DELAY. THE SALES REP STATED THAT THE CUSTOMER DISCARDED THE DEVICE.

  Patient problems: Not Applicable

  MAUDE report 8994853 ↗
• InjuryAug 16, 2019Break; Migration or Expulsion of Device; Break; Migration or Expulsion of Device

  IT WAS REPORTED BY THE SALES REP VIA EMAIL THAT DURING AN ACL REVISION PROCEDURE THEIR INTRAFIX ADVANCE BR LARGE 9X30MM, THE SURGEON HAD PREPPED THE TIBIAL TUNNEL AND SOFT TISSUE ALLOGRAFT APPROPRIATELY. THE ALLOGRAFT WAS FIXATED ON THE FEMORAL SIDE, KNEE CYCLED, THEN THE TIBIAL SIDE WAS PUT ON THE TIE TENSIONER AND READY TO RECEIVE THE INTRAFIX ADVANCE IMPLANTS. THEY HAD A 10MM GRAFT SO WERE USING THE APPROPRIATE LARGE TRIAL. IT WASN¿T GOING DOWN VERY WELL, SO THEY USED THE SMALL TRIAL TO CREATE A BETTER PATH. ONCE THEY GOT THE SMALL TRIAL DOWN SMOOTHLY, THEY THEN WENT BACK TO THE LARGE TRIAL AND GOT IT SEATED. THE SURGEON OPTED TO DOWNSIZE THE SCREW TO THE 9X30MM SINCE THINGS JUST SEEMED TO BE A BIT TIGHT. THE SHEATH WAS IMPLANTED USING THE LARGE 30MM SHEATH INSERTER. AS THEY STARTED TO INSERT THE SCREW INTO THE SHEATH, THE SHEATH WAS BACKING OUT AND JUST CRUMBLING INTO PIECES. AFTER THE SCREW WAS ABOUT 1/3 TO ½ WAY IN, THE SCREW AND SHEATH WERE JUST TRYING TO TURN TOGETHER AS ONE UNIT. IT WAS CLEAR THEY WERE NOT GOING TO GET THE SCREW SEATED AND THE SHEATH WAS SHREDDED. THE SURGEON BACKED THE SCREW OUT, USED A HEMOSTAT TO REMOVE THE PIECES OF THE SHEATH, AND THEN OPTED TO USE A

  Patient problems: No Code Available; Not Applicable

  MAUDE report 8903428 ↗