MILAGRO 231818Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 10886705022342), received between Jun 14, 2018 and Sep 30, 2026 — classified as 6 injuries, 32 malfunctions.

The most frequently reported specific device problem is “Break” (25 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 38 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951659 ↗
• MalfunctionJun 15, 2026Difficult to Advance

  IT WAS REPORTED THAT THE EVENT OCCURRED DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION. DURING THE FIXATION OF THE TIBIA SIDE USING A BONE-TENDON-BONE AUTOGRAFT, THE MILAGRO 10MM SCREW WAS USED BUT IT DID NOT ADVANCE SMOOTHLY. THE LACK OF ADVANCE WAS FELT EVEN AFTER USING A TAP, SO THE 9 × 23 MM SCREW WAS CHANGED TO A 8 × 23MM. THE SURGERY WAS COMPLETED WITH NO ISSUES. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25505858 ↗
• MalfunctionFeb 17, 2026Break

  DURING ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION, THE MILAGRO ADVANCE SCREW 9X23MM WAS FRACTURED WHEN TIBIAL FIXATION WAS PERFORMED. ANOTHER IMPLANT WAS REQUIRED TO ENSURE FIXATION AND AVOID CAUSING HARM TO THE PATIENT. THE FRAGMENT WAS SUCCESSFULLY REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24367540 ↗
• MalfunctionFeb 17, 2026Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) REPAIR SURGICAL PROCEDURE, WHEN INSERTING THE MILAGRO ADVANCE SCREW 9X23MM DEVICE, IT WAS OBSERVED THAT THE SCREW WAS BROKEN. IT WAS REPORTED THAT ALL BROKEN 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 24367358 ↗
• MalfunctionFeb 4, 2026Break

  IT WAS REPORTED THAT DURING THE SURGERY, THE SCREW WAS BROKEN, ALL THE PIECES WERE REMOVED FROM THE PATIENT. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, 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. THIS IS REPORT 1 OF 2 FOR THE SAME EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24260596 ↗
• MalfunctionDec 5, 2025Crack; Crack

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT BUMP FELLOW BONE PROCEDURE WORKING ON THE FEMORAL SIDE, WHILE USING THE MILAGRO ADVANCE SCREW 9X23MM DEVICE, THE TUNNEL AND THE BONE BLOCK WERE ALIGNED IN LINE MEANING WE DRILLED A SIZE 10 AND INSERTED A SIZE 10 BONE BLOCK. ONCE INSERTING THE MEGA WIRE CAP WAS INTRODUCED AND MILAGRO SCREW WAS INSERTED, AND CRACK WAS ABLE. THE SCISSOR WAS ABLE TO REMOVE THE FRAGMENTS. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE EXACT DATE OF THIS EVENT WAS UNKNOWN BUT WAS NOTED TO HAVE OCCURRED IN 2025. 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 23727587 ↗
• MalfunctionAug 27, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT REPAIR SURGERY, IT WAS OBSERVED THAT THE MILAGRO ADVANCE SCREW 9X23MM 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 22901832 ↗
• MalfunctionAug 14, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT REPAIR SURGERY, IT WAS OBSERVED THAT UPON OPENING THE BOX AND PLACING THE SCREW ON THE GUIDEWIRE, THE SURGEON NOTICED PLASTIC BUILD UP ON THE MILAGRO ADVANCE SCREW 9X23MM DEVICE DISTAL TIP OF THE SCREW INSIDE THE CANNULATED PORTION OF THE SCREW BODY. 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 22804019 ↗
• MalfunctionApr 30, 2025Break; Break

  IT WAS REPORTED THAT DURING A CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE, IT WAS FOUND THAT THE TIP OF THE ANCHOR ON THE MILAGRO ADVANCE SCREW 9X23MM DEVICE BROKE OFF WHEN IT WAS IMPLANTED INTO THE PATIENT'S TIBIA. 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 21936043 ↗
• MalfunctionJan 16, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ACL (ANTERIOR CRUCIATE LIGAMENT) REPAIR PROCEDURE, IT WAS DISCOVERED THAT THE ANCHOR ON THE MILAGRO ADVANCE SCREW 9X23MM 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. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21170738 ↗
• MalfunctionJan 15, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE, IT WAS OBSERVED THAT THE DEVICE BROKE OFF, THEN ALL THE BROKEN PARTS WERE REMOVED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 21158691 ↗
• MalfunctionJan 9, 2025Break; Break

  IT WAS REPORTED THAT DURING A LIGAMENT RECONSTRUCTION SURGICAL PROCEDURE THE MILAGRO ADVANCE SCREW DEVICE ANCHOR WAS BROKEN OFF. ALL BROKEN PARTS WERE REMOVED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. IT WAS UNKNOWN IF THERE WAS DELAY TO THE PROCEDURE. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21117185 ↗
• MalfunctionMay 22, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT PROCEDURE, THE MILAGRO ADVANCE SCREW 9X23MM DEVICE ANCHOR WAS BROKEN OFF, REMOVED ALL THE BROKEN PARTS. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THE EXACT DATE OF THIS EVENT IS UNKNOWN. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19369476 ↗
• MalfunctionMay 1, 2024Break; Break

  IT WAS REPORTED FROM FRANCE THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) REPAIR PROCEDURE, IT WAS DISCOVERED THAT THE MILAGRO ADVANCE SCREW 9X23MM DEVICE BROKE INTO TWO DURING INSERTION OF THE SCREW ON THE GRAFT AT THE TIBIAL. ACCORDING TO THE REPORT, THE IMPLANT WAS HANDLED PROPERLY, AND THE TAP WAS USED BEFORE INSERTING THE SCREW. THERE WAS THIRTY-MINUTE DELAY TO THE SURGICAL PROCEDURE. IT WAS ALSO NOTED THAT FRAGMENTS WERE GENERATED, AND THE IMPLANT WAS PARTIALLY REMOVED. THE SURGERY WAS COMPLETED SUCCESSFULLY. IT WAS NOT REPORTED IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 19222979 ↗
• MalfunctionMar 13, 2024Crack; Crack

  IT WAS REPORTED FROM JAPAN THAT DURING AN ARCR(ARTHROSCOPIC ROTATOR CUFF REPAIR) TENODESIS SURGICAL PROCEDURE ON (B)(6) 2024, IT WAS OBSERVED THAT THE SURGEON ATTEMPTED TO PUT THE MILAGRO ADVANCE SCREW 9X23MM DEVICE OF THE SAME SIZE AS THE REAMER INTO THE BONE HOLE AS USUAL; HOWEVER, IT DID NOT GO IN SMOOTHLY, AND THERE WAS A SNAPPING SOUND. THEREFORE, THE SCREWDRIVER AND THE MILAGRO DEVICE WERE REMOVED FROM THE BODY. IT WAS CONFIRMED THAT THE MILAGRO WAS CRACKED. THERE WAS NO BROKEN PIECE IN THE PATIENT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THE DEVICE WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18892683 ↗
• MalfunctionOct 6, 2023Delivered as Unsterile Product; Packaging Problem; Delivered as Unsterile Product; Packaging Problem

  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 INNER PACKAGING OF THE 9X23MM MILAGRO ADVANCE INTERFERENCE SCREW DEVICE WAS DAMAGED WHEN IT WAS TAKEN OUT OF THE OUTSIDE PACKAGING; AND THEREFORE, WAS NOT USED. 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 17886546 ↗
• MalfunctionAug 24, 2023Break; Break

  IT WAS REPORTED BY THE SALES REP IN ESTONIA THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE 9X23MM MILAGRO ADVANCE INTERFERENCE SCREW DEVICE BROKE UPON INSERTION THEN 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 17615713 ↗
• MalfunctionNov 22, 2022Break; Break

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN CHINA THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE 9X23MM MILAGRO ADVANCE INTERFERENCE SCREW DEVICE WAS BROKEN OFF. REMOVED ALL THE BROKEN PARTS. 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 15846077 ↗
• MalfunctionOct 19, 2022Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN RUSSIA THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE 9X23MM MILAGRO ADVANCE INTERFERENCE SCREW DEVICE BROKE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A DELAY OF APPROXIMATELY 30 MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15633768 ↗
• 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 (DPS_JMP_2018_067) CONTRACT MILESTONE DELIVERABLE THAT POSTOPERATIVELY TO AN ANTERIOR CRUCIATE LIGAMENT PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE 9X23MM 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 14991063 ↗
• MalfunctionJun 30, 2022Break; Break

  IT WAS REPORTED BY THE SALES REP IN SWEDEN THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE 9X23MM MILAGRO ADVANCE INTERFERENCE SCREW 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 14876008 ↗
• MalfunctionJun 29, 2022Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN COLOMBIA THAT DURING AN UNKNOWN SURGERY ON 6/14/2022, IT WAS OBSERVED THAT THE 9X23MM MILAGRO ADVANCE INTERFERENCE SCREW DEVICE BROKE. ACCORDING TO THE REPORT, WHILE INSERTING THE NITINOL GUIDE, THE SCREW WAS PLACED IN THE FEMORAL TUNNEL, LEAVING THE NITINOL GUIDE TRAPPED. IT WAS REPORTED THAT WHEN TRYING TO REMOVE TRAPPED NITINOL GUIDE, THE SCREW WAS MOVED BACK A FEW MILLIMETERS, THEN ADVANCED BUT THE COIL ON THE DEVICE BROKE INTO THREE FRAGMENTS BEFORE FINISHING. ALL FRAGMENTS WERE RECOVERED WHICH CAUSED AN HOUR DELAY IN THE PROCEDURE. A DOUBLE-ROW ANCHOR WAS USED TO COMPLEMENT THE FIXATION OF THE GRAFT IN THE FEMUR. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 14857724 ↗
• MalfunctionJun 14, 2022Material Deformation; Material Deformation

  THIS IS REPORT 2 OF 5 FOR (B)(4). IT WAS REPORTED BY THE AFFILIATE IN JAPAN THAT DURING A TENDON FUSION IN THE BICEPS AND ROTATOR CUFF SUTURING PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE GRAFT WAS DAMAGED AND TWISTED WHILE USING 9X23MM MILAGRO ADVANCE INTERFERENCE SCREW DEVICE. THE PROCEDURE WAS DELAYED BY 90 MINUTES. 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 14688951 ↗
• InjuryJan 11, 2022Break; Break

  IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING A TIBIAL FIXATION OF THE NEO-LIGAMENT ON (B)(6) 2021, IT WAS OBSERVED THAT A PART OF THE GUIDEWIRE ON THE MILAGRO ADVANCE SCREW 9X23MM DEVICE BROKE AND REMAINED INSIDE THE KNEE JOINT. ACCORDING TO THE REPORT, THE FRAGMENT WAS NOT NOTICED DURING THE SURGICAL PROCEDURE OR EVEN AT THE X-RAY CONTROL DESPITE THE REPORT INDICATING THE PRESENCE OF THE WIRE. THEN ON (B)(6) 2021, ARTHROSCOPIC CLEANING AND REMOVAL OF THE GUIDE WIRE FRAGMENT WAS CARRIED OUT (ABOUT 5 CM). THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 13225915 ↗
• InjuryDec 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE SURGEON THAT POSTOPERATIVELY TO AN UNKNOWN SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE PATIENT SEEMED TO BE HAVING AN ALLERGIC REACTION TO THE MILAGRO ADVANCE SCREW 9X23MM DEVICE. ACCORDING TO THE REPORTER, THE PATIENT HAS DEVELOPED RASH EXTERNALLY AROUND THE INCISION SITE WHERE THE DEVICE WAS PLACED. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 13003912 ↗