MILAGRO 231817Recalls & reported problems

Summary

The FDA's MAUDE database contains 96 adverse event reports that list this exact device (DI 10886705022250), received between Mar 23, 2018 and Sep 16, 2026 — classified as 9 injuries, 87 malfunctions.

The most frequently reported specific device problem is “Break” (70 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 96 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50794096 ↗
• MalfunctionApr 29, 2026Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY SURGERY, THE INTERFERENCE SCREW BROKE DURING INSERTION WITH THE MILAGRO ADVANCE SCREW 8X23MM DEVICE. IT WAS NOT REPORTED WHETHER THERE WERE ANY DELAYS TO THE SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY. 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 25034311 ↗
• MalfunctionApr 22, 2026Break

  THIS IS REPORT 2 OF 2 OF (B)(4). IT WAS REPORTED THAT DURING AN (ACL) ANTERIOR CRUCIATE LIGAMENT REPAIR PROCEDURE A MILAGRO ADVANCE SCREW 7X23MM, THE SCREW BROKE, AND ALL THE PIECES WERE REMOVED FROM THE PATIENT. THEY CHANGED TO ANOTHER MILAGRO ADVANCE SCREW 8X23MM, BUT 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 24953296 ↗
• MalfunctionApr 16, 2026Break

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE IT WAS OBSERVED THAT WHILE USING THE MILAGRO ADVANCE SCREW 8X23MM DEVICE, WHILE INSERTING THE SCREW, IT BROKE IMMEDIATELY. 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 24899995 ↗
• MalfunctionMar 17, 2026Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE MILAGRO ADVANCE SCREW 8 X 23 MM DEVICE SCREW BROKEN OFF. ALL BROKEN PIECES WERE REMOVED. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE REPORTS OF A DELAY TO 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 24618211 ↗
• MalfunctionFeb 5, 2026Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE GRYPHON P BR DS ANCHOR W/OC ANCHOR DEVICE, THE RGDFX CRVE ST ACL PLA XPIN SYS DEVICE AND THE MILAGRO ADVANCE SCREW 8X23MM DEVICE WERE BROKEN. IT WAS REPORTED THAT ALL THE BROKEN PARTS WERE REMOVED. SPARE DEVICES WERE USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE EXACT DATE OF THE EVENT WAS NOT REPORTED; HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN DECEMBER OF 2025. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24273569 ↗
• MalfunctionFeb 4, 2026Break

  IT WAS REPORTED THAT DURING A JOINT SURGICAL PROCEDURE IT WAS OBSERVED THAT THE MILAGRO ADVANCE SCREW DEVICE SCREW WAS BROKEN. TWO DEVICES AND TWO SCREWS WERE BROKEN. 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 24260991 ↗
• MalfunctionFeb 3, 2026Break

  THIS IS REPORT 1 OF 4 FOR (B)(4). IT WAS REPORTED THAT DURING A JOINT PROCEDURE, THE ANCHOR ON THE 5.5 HEALIX ADVANCE KNTLSS BR DEVICE BROKE OFF AND ALL BROKEN PARTS WERE REMOVED. THE MILAGRO ADVANCE SCREW 8X23MM DEVICE, SUBSTITUTED TO CONTINUE THE SURGERY, BROKE DURING INSERTION AND ALL PIECES WERE REMOVED FROM THE PATIENT. A REPLACEMENT ANCHOR AND SCREW WERE USED TO CONTINUE THE SURGERY, BUT THE SAME FAILURE RECURRED AND BOTH DEVICES BROKE AGAIN. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS TO THE SURGICAL PROCEDURE. IT WAS REPORTED THAT SPARE DEVICES WERE USED TO COMPLETE THE SURGERY. 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 SEPTEMBER 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24251064 ↗
• MalfunctionJan 25, 2026Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE MILAGRO ADVANCE SCREW 8X23MM DEVICE 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 COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24175502 ↗
• MalfunctionJan 5, 2026Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE OF THE KNEE JOINT IT WAS OBSERVED THAT THE MILAGRO ADVANCE SCREW 8X23MM DEVICE BROKE AND 2X 5.5 HEALIX ADVANCE KNTLSS BR ANCHOR DEVICES BROKE. IT WAS REPORTED THAT ALL BROKEN PIECES WERE REMOVED FROM THE PATIENT. 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 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23965875 ↗
• MalfunctionDec 17, 2025Break; Break

  IT WAS REPORTED THAT DURING A COLLATERAL LIGAMENT REPAIR PROCEDURE, IT WAS DISCOVERED THAT THE ANCHOR ON THE MILAGRO ADVANCE SCREW 8X23MM 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 23830979 ↗
• MalfunctionDec 15, 2025Crack; Crack

  REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED THAT THE MILAGRO ADVANCE SCREW 8X23MM DEVICE USED ON THE TIBIAL SIDE PLACEMENT TUNNEL WAS TOO TIGHT AND THE SCREW CRACKED AND THE MILAGRO ADVANCE SCREW 10X23MM DEVICE USED ON THE FEMORAL SIDE PLACEMENT TUNNEL WAS TOO TIGHT AND THE SCREW GOT CRACKED. IT WAS REPORTED THAT FRAGMENTS WERE REMOVED. 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 23800998 ↗
• MalfunctionSep 15, 2025Break; Break

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY SURGERY, THE MILAGRO ADVANCE SCREW 8X23MM 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 23052984 ↗
• InjuryJul 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS REPORT 8 OF 10 FOR (B)(4). IT WAS REPORTED THROUGH A REVIEW OF NEW ZEALAND ACL REGISTRY DEPUY IMPLANT REPORT RECEIVED AS PER DUA-SPORTS-2024-017 CONTRACT MILESTONE DELIVERABLE THAT POSTOPERATIVELY TO AN ANTERIOR CRUCIATE LIGAMENT PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE MILAGRO ADVANCE SCREW 8X23MM DEVICE FAILED AND THE PATIENT REQUIRED A RE-OPERATION OR REVISION SURGERY. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 22579231 ↗
• MalfunctionJul 23, 2025Break; Break

  DURING SURGERY, AT THE TIME WHEN TUNNELING WAS PERFORMED IN THE FEMUR, THE TENDON WAS FIXED WITH A MILAGRO ADVANCE SCREW DEVICE. IT HAPPENED THAT WHEN THE SURGEON WAS PLACING THE SCREW WITH THE RACHET HANDLE, ITS DISTAL PART WAS BROKEN. THIS NOVELTY DID NOT CAUSE DAMAGE OR AFFECT THE PATIENT BECAUSE 2/3 OF THE REMAINING SCREW WERE LEFT IN THE FEMUR TUNNEL DOING THE FUNCTION OF INTERFERENCE. THIS BEING THE REASON WHY THERE WAS NO DISCOMFORT ON THE PART OF THE SPECIALIST. THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY TO THE SURGICAL 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 22578257 ↗
• MalfunctionJul 18, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT PROCEDURE, THE MILAGRO ADVANCE SCREW 8X23MM DEVICE ANCHOR WAS BROKEN OFF, REMOVED ALL THE BROKEN PARTS. 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 22540677 ↗
• MalfunctionMay 29, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGICAL PROCEDURE, THE MILAGRO ADVANCE SCREW 8X23MM DEVICE BROKE OFF. 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 22104063 ↗
• MalfunctionMay 29, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT PROCEDURE, THE MILAGRO ADVANCE SCREW 8X23MM DEVICE, WHEN INSERTING THE SCREW, THE SCREW BROKE. 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 22104049 ↗
• MalfunctionApr 1, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT REPAIR PROCEDURE, IT WAS DISCOVERED THAT THE ANCHOR ON THE MILAGRO ADVANCE SCREW 8X23MM 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 21740178 ↗
• MalfunctionDec 4, 2024Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) AND A LATERAL EXTRA-ARTICULAR TENODESIS (LET) SURGICAL PROCEDURE ON THE KNEE JOINT FOR AN ACL TEAR ON THE KNEE, WHILE USING THE MILAGRO ADVANCE SCREW 8X23MM DEVICE, DURING THE LET PORTION OF THE PROCEDURE, THE SURGEON ATTEMPTED TO DRIVE A GUIDE PIN AND AFTER OVER DRILLING, DRAWN IN THE GRAFT AND FIX IT WITH THE SCREW IN QUESTION. HOWEVER, THE SCREW COULD NOT BE INSERTED EASILY. THEREFORE, THE SURGEON USED A NEW SCREW ONE SIZE SMALLER FIXATION BECAUSE IT COULD INVOLVE AND DAMAGE THE GRAFT. THE NEWLY USED SCREW WAS ALSO DIFFICULT TO INSERT AT FIRST, BUT AFTER CHECKING THE INSERTION ANGLE FROM EXTENSION TO FLEXION, IT WAS INSERTED AND FIXED FIRMLY. THE SURGEON OPENED THAT THE PATIENT'S BONES AND MAY HAVE BEEN A LITTLE STIFF, BUT THAT THE ANGLE MAY HAVE BEEN SLIGHTLY OFF. THERE WAS A THIRTY MINUTE DELAY TO THE PROCEDURE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20846679 ↗
• MalfunctionOct 25, 2024Break; Break

  IT WAS REPORTED FROM CHINA THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE MILAGRO ADVANCE SCREW 8X23MM ANCHOR BROKE OFF. IT WAS REPORTED THAT ALL THE BROKEN PARTS WERE REMOVED. ANOTHER LIKE 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 20534133 ↗
• MalfunctionOct 9, 2024Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE MILAGRO ADVANCE SCREW 8X23MM DEVICE BROKE AS SOON AS THE SURGEON APPLIED SOME FORCE TO FIX IT. ACCORDING TO THE REPORT, FRAGMENTS WERE GENERATED BUT WERE REMOVED. THERE WAS PATIENT INVOLVEMENT. 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 20410985 ↗
• InjuryJul 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORT 3 OF 4 FOR THIS EVENT. IT WAS REPORTED BY THE CLINICAL RESEARCH TEAM THAT DURING A MENISCAL REPAIR PROCEDURE ON (B)(6) 2024, 2 XTRUESPAN 24 DEGREE PEEK DEVICES AND 2X MILAGRO ADVANCE SCREW 8X23MM DEVICES WERE USED. ACCORDING TO THE REPORTER, POSTOPERATIVELY THE PATIENT HAD RE-TEARS/NEW TEARS. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 19835236 ↗
• InjuryJul 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORT 4 OF 4 FOR THIS EVENT. IT WAS REPORTED BY THE CLINICAL RESEARCH TEAM THAT DURING A MENISCAL REPAIR PROCEDURE ON (B)(6) 2024, 2 XTRUESPAN 24 DEGREE PEEK DEVICES AND 2X MILAGRO ADVANCE SCREW 8X23MM DEVICES WERE USED. ACCORDING TO THE REPORTER, POSTOPERATIVELY THE PATIENT HAD RE-TEARS/NEW TEARS. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 19835235 ↗
• InjuryJul 16, 2024Adverse 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 THAT POSTOPERATIVELY TO AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION AND A MENISCAL REPAIR PROCEDURE USING THE MILAGRO ADVANCE SCREW 7X23MM AND THE MILAGRO ADVANCE SCREW 8X23MM DEVICES, THE PATIENT DEVELOPED AN INFECTION. IT WAS REPORTED THAT THE SURGERY WAS PERFORMED ON THE PATIENT¿S RIGHT SIDE. PATIENT INVOLVEMENT AND INJURY/INFECTION WERE REPORTED. IT WAS REPORTED THAT THE EVENT RESULTED IN A REVISION PROCEDURE. THERE WAS NO ALLEGED MALFUNCTION AGAINST THE DEVICES. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Unspecified Infection

  MAUDE report 19752721 ↗