BIOINTRAFIXRecalls & reported problems across all models

We found 6 models of BIOINTRAFIX by Medos International Sàrl in the FDA's device registry (GUDID). Together they are named in 280 adverse event reports in the FDA's MAUDE database, received between May 21, 2018 and May 20, 2026 — classified as 34 injuries, 246 malfunctions.

The most frequently reported specific device problem is “Break” (209 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

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

• BIOINTRAFIX 254628

  Screw, fixation, bone
  91 reports
• BIOINTRAFIX 254660

  Screw, fixation, bone
  56 reports
• BIOINTRAFIX 254624

  Screw, fixation, bone
  54 reports
• BIOINTRAFIX 254629

  Screw, fixation, bone
  46 reports
• BIOINTRAFIX 254622

  Screw, fixation, bone
  25 reports
• BIOINTRAFIX 254625

  Screw, fixation, bone
  8 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.

• MalfunctionMay 20, 2026Break

  IT WAS REPORTED THAT DURING ARTHROSCOPIC ROTATOR CUFF REPAIR SURGERY, THE TAIL OF THE BIOINTRAFIX WAS BROKEN. ALL THE BROKEN PARTS WERE REMOVED. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25228271 ↗
• 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 12, 2026Break

  IT WAS REPORTED THAT DURING ANTERIOR CRUCIATE LIGAMENT PROCEDURE, THE BIOINTRAFIX 6-7MMX30MMTPRSCR DEVICE WHEN INSERTING THE SCREW, THE SCREW 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 WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24035950 ↗
• MalfunctionJan 9, 2026Break

  THIS IS REPORT 1 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 24020526 ↗
• 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 ↗
• InjuryDec 11, 2025Migration; Migration

  REPORT 1 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 23782902 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionAug 13, 2025Break; Break

  REPORT 1 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 22792068 ↗
• 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 ↗
• 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 ↗

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