MILAGRO 231823Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10886705022281), received between Apr 10, 2018 and May 4, 2026 — classified as 3 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Break” (12 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 4, 2026Crack

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT THE MILAGRO ADVANCE SCREW 10X30MM DEVICE SCREW CRACKED WHILE INSERTING INTO THE PATIENT. 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. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25070612 ↗
• MalfunctionMay 5, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGICAL PROCEDURE, THE MILAGRO ADVANCE SCREW 10X30MM DEVICE WHEN INSERTING THE SCREW, THE SCREW'S WAS BROKEN. ALL OF 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 21959595 ↗
• MalfunctionFeb 12, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE MILAGRO 10X30 SCREW BROKE DURING FIXATION OF THE SCREW. THERE WAS NO REPORTED SURGICAL DELAY AND NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21367435 ↗
• MalfunctionSep 16, 2024Break; Break

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING A HAMSTRING ANTERIOR CRUCIATE LIGAMENT PROCEDURE, IT WAS DISCOVERED THAT THE PIN TIP OF THE NITINOL GUIDEWIRE 1.1MM X 38.1CM (15 INCHES) DEVICE BROKE OFF IN THE GRAFT WITHIN THE PATIENT'S TIBIA. IT WAS FURTHER REPORTED THAT THE DEVICE BROKE AT THE 30 MM LINE, BREAKING THE 10×30 SCREW. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. AN X-RAY WAS USED TO DETERMINE PIN PLACEMENT, AND THE GRAFT HAD TO BE CUT OUT AND REDONE WITH A NEW BUTTON AND SCREW. THERE WAS TWENTY-MINUTE DELAY TO THE SURGICAL PROCEDURE. THERE WAS PATIENT INVOLVEMENT REPORTED. NO INJURIES WERE REPORTED, BUT THERE WAS MEDICAL INTERVENTION REQUIRED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20227545 ↗
• MalfunctionJun 13, 2024Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) SURGICAL PROCEDURE ON (B)(6) 2024 THE MILAGRO ADVANCE SCREW 10X30MM DEVICE SCREW WAS BROKEN. 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 19528916 ↗
• MalfunctionJan 24, 2024Break; Break

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN FRANCE THAT DURING A SEMI-TENDINOUS INTERNAL RIGHT) FOR THE FIXATION OF THE TIBIAL IMPLANT PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE MILAGRO ADVANCE SCREW 10X30MM DEVICE BROKE UPON INSERTION. 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 18574142 ↗
• MalfunctionJan 5, 2024Break; Break

  IT WAS REPORTED BY THE SALES REP IN CHINA THAT DURING AN ANTERIOR CRUCIATE LIGAMENT REPAIR SURGERY ON (B)(6) 23 THE BIOINTRAFIX 8-10MMX30MM TPRSCR DEVICE ANCHOR WAS BROKEN OFF. CHANGED ANOTHER BIOINTRAFIX 8-10MMX30MM TPRSCR DEVICE AND TWO MILAGRO ADVANCE SCREW 10X30MM DEVICES 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 ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18450214 ↗
• MalfunctionJan 5, 2024Break; Break

  IT WAS REPORTED BY THE SALES REP IN CHINA THAT DURING AN ANTERIOR CRUCIATE LIGAMENT REPAIR SURGERY ON (B)(6) 2023 THE BIOINTRAFIX 8-10MMX30MM TPRSCR DEVICE ANCHOR WAS BROKEN OFF. CHANGED ANOTHER BIOINTRAFIX 8-10MMX30MM TPRSCR DEVICE AND TWO MILAGRO ADVANCE SCREW 10X30MM DEVICES 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 ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18449861 ↗
• InjuryDec 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE SALES REP IN HONG KONG THAT DURING POSTOPERATIVELY TO AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE, IT WAS OBSERVED THAT THE IMPLANTED 10X30MM MILAGRO ADVANCE INTERFERENCE SCREW DEVICE SHOWED ABNORMALITY THROUGH PATIENT'S MRI. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Inflammation; Swelling/ Edema

  MAUDE report 15950436 ↗
• MalfunctionAug 2, 2022Break; Break

  IT WAS REPORTED BY THE SALES REP IN SWITZERLAND THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE 10X30MM MILAGRO ADVANCE INTERFERENCE SCREW DEVICE BROKE INTO TWO PARTS UPON INSERTION ON THE SECOND TIME. ACCORDING TO THE REPORT, THE POINT REMAINED IN THE TUNNEL WHILE THE DISTAL PART CAME OUT WITH THE SCREWDRIVER. IT WAS FURTHER REPORTED THAT THE SURGEON PUSHED THE TIP THAT REMAINED TOWARD THE TIBIAL TUNNEL IN THE KNEE JOINT AND INSERTED ANOTHER SCREW. THE PROCEDURE WAS COMPLETED WITH A DELAY OF FIVE MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15147880 ↗
• 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 10X30MM MILAGRO ADVANCE INTERFERENCE SCREW 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 14991302 ↗
• InjuryFeb 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE AFFILIATE VIA EMAIL, A PATIENT WAS OPERATED ARTHROSCOPICALLY FOR ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION AND IT WAS USED A MILAGRO ADVANCE 10X30 MITEKTHE PATIENT CONTINUES TO HAVE GRAPEVINE PROBLEMS WITH BONE MARROW EDEMA AND PAIN, TREATED WITH VARIOUS METHODS WITHOUT RESULT. THE "PAITIENT'S" MOTHER SEARCHED ON THE INTERNET AND FOUND OUR RECENT SECURITY ADVISORY REGARDING MILAGRO ADVANCE, HEALIX, INTRAFIX AND WROTE A LETTER TO THE "SURGERON".

  Patient problems: Edema; Pain

  MAUDE report 9668107 ↗
• MalfunctionNov 1, 2019Break; Break

  IT WAS REPORTED BY THE AFFILIATE VIA COMPLAINT SUBMISSION TOOL THAT DURING AN ACL RECONSTRUCTION THE MILAGRO ADVANCE SCREW 10X30MM BROKE WHEN IT WAS INSERTED. THE PROCEDURE WAS COMPLETED USING A NEW MILAGRO ADVANCE SCREW 10X30MM. FRAGMENTS WERE GENERATED, BUT REMOVED EASILY WITH NO ADDITIONAL INTERVENTION. ALSO, IT WAS REPORTED A SURGICAL DELAY OF 5 MINUTES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Not Applicable

  MAUDE report 9268556 ↗
• MalfunctionAug 8, 2018Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING ANTERIOR CRUCIATE LIGAMENT (ACL) FIXATION AND DISTAL FIXATION, IT WAS OBSERVED THAT THE TIP OF MILAGRO ADVANCE SCREW, 10X30MM BROKE. IT WAS REPORTED THAT THE TUNNEL SIZE WAS THE SAME AS THE SCREW. IT WAS REPORTED THAT THE SURGEON TAPPED. IT WAS REPORTED THAT ALL BROKEN FRAGMENTS WERE REMOVED. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED BY USING A NORMAL MILAGRO SCREW. IT WAS REPORTED THAT THE INSERTION WAS NOT OFF AXIS. IT WAS REPORTED THAT THE PATIENT HAD NORMAL BONE. IT WAS REPORTED THAT THE PROCEDURE WAS NOT EXTENDED GREATER THAN 30 MINUTES.. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7762218 ↗
• MalfunctionMay 24, 2018Break; Break

  IT WAS REPORTED THAT THERE WAS SCREW BREAKAGE. THE SCREW BROKE TO TWO PIECES DURING ACL RECONSTRUCTION. THE BROKEN PIECES WERE RETRIEVED. THERE WAS NO REPORT ON PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7542845 ↗
• MalfunctionApr 10, 2018Break; Break

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION PROCEDURE, THE SURGEON WAS USING THIS 10 X 30MM SCREW ON A 9MM TIBIAL TUNNEL. THE TIP OF THE SCREW BROKE AS HE WAS INSERTING IT. HE DISCARDED IT AND USED ANOTHER SCREW TO COMPLETE THE PROCEDURE. SUCCESSFUL RECONSTRUCTION. NO AE TO PATIENT. NO DELAY TO PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7412202 ↗