MILAGRO 231831Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10886705023301), received between May 22, 2018 and Jun 30, 2026 — classified as 1 injury, 17 malfunctions.

The most frequently reported specific device problem is “Break” (15 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 16, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 30, 2026Break

  IT WAS REPORTED THAT DURING ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY THE MILAGRO ADVANCE SCREW 7X30MM DEVICE BROKE DURING SCREW IMPLANTATION. ALL PIECES WERE REMOVED FROM THE PATIENT. THE SURGERY WAS DELAYED BY TEN MINUTES. A DIFFERENT DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25670047 ↗
• MalfunctionMay 26, 2026Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT REPAIR PROCEDURE, WHEN USING THE MILAGRO ADVANCE SCREW 7X30MM DEVICE, IT WAS OBSERVED THAT THE SCREW WAS BROKEN. IT WAS REPORTED THAT ALL PIECES WERE REMOVED FROM THE PATIENT. IT WAS REPORTED THAT 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 25284267 ↗
• MalfunctionMay 12, 2026Break

  IT WAS REPORTED THAT DURING ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION, THE MILAGRO 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 25149074 ↗
• MalfunctionMay 5, 2026Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC KNEE PROCEDURE THE MILAGRO ADVANCE SCREW 7X30MM ANCHOR DEVICE BROKE. ALL THE 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. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25086018 ↗
• MalfunctionMay 5, 2026Break

  THIS IS REPORT 1 OF 3 FOR (B)(4). IT WAS REPORTED THAT DURING A CRUCIATE LIGAMENT OF THE KNEE JOINT PROCEDURE, IT WAS DISCOVERED THAT THE ANCHOR ON THE RGDFX CRVE ST ACL PLA XPIN SYS DEVICE BROKE OFF. ALL THE BROKEN PARTS WERE REMOVED. IT WAS FURTHER REPORTED THAT THE SCREW ON THE MILAGRO ADVANCE SCREW 7X30MM DEVICE ALSO BROKE OFF. ALL THE PIECES WERE REMOVED FROM THE PATIENT. A REPLACEMENT DEVICE WAS USED TO CONTINUE THE SURGERY, BUT THE SAME ISSUE OCCURRED AGAIN. THERE WERE NO DELAYS IN 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 25084883 ↗
• MalfunctionFeb 3, 2026Break

  THIS IS REPORT 3 OF 3 FOR (B)(4). IT WAS REPORTED THAT DURING A KNEE JOINT PROCEDURE, THE OMNISPAN MENISCAL REPAIR 27DEG DEVICE PULLED OUT AND THE MILAGRO ADVANCE SCREW 8X30MM AND MILAGRO ADVANCE SCREW 7X30MM DEVICES BROKE. 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 24250620 ↗
• MalfunctionNov 19, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT REPAIR (ACL) SURGICAL PROCEDURE IT WAS OBSERVED THAT THE MILAGRO ADVANCE SCREW DEVICE SCREW WAS BROKEN. 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 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 23597865 ↗
• MalfunctionMar 3, 2025Break; Break

  REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING THE LIGAMENT RECONSTRUCTION SURGERY, THE MILAGRO ADVANCE SCREW 9X30MM DEVICE WAS BROKEN OFF, CHANGED TO ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN, 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 21502703 ↗
• MalfunctionDec 27, 2024Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THE MILAGRO ADVANCE SCREW 7X30MM ANCHOR WAS BROKE OFF, REMOVED ALL THE BROKEN PARTS. CHANGED ANOTHER MILAGRO ADVANCE SCREW 7X30MM DEVICE 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 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21028256 ↗
• InjuryAug 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS REPORT 4 OF 8 FOR (B)(4). IT WAS REPORTED THROUGH CLINICAL RESEARCH STUDY THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) RECONSTRUCTION WITH LATERAL COLLATERAL LIGAMENT (LCL) REPAIR PROCEDURES ON (B)(6) 2023, A MILAGRO ADVANCE SCREW 7X30MM DEVICE WAS USED. ACCORDING TO THE REPORT, POSTOPERATIVELY ON (B)(6) 2024, THE PATIENT HAD JOINT STIFFNESS WITH REDUCED RANGE OF MOTION. IT WAS REPORTED THAT THE EVENT DID NOT RESULT IN A REOPERATION/REVISION PROCEDURE. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 19950424 ↗
• MalfunctionFeb 13, 2024Break; Break

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN CHINA THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON 2/3/2024, IT WAS OBSERVED THAT THE MILAGRO ADVANCE SCREW 7X30MM DEVICE WAS BROKEN OFF, THEN REMOVED ALL THE BROKEN PARTS. 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 18695589 ↗
• MalfunctionSep 17, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: ANCHOR WAS PULLED OUT. IT WAS REPORTED THAT DURING THE ACL RECONSTRUCTION, USED SCREW DRIVER TO INSERT THE ANCHOR, WHEN REMOVED THE DRIVER, THE SCREW ALSO WAS PULLED OUT. CHANGED ANOTHER SCREW, THE EVENT RE-HAPPENED. CHANGED ANOTHER SCREW WITH THIS DRIVER COULD INSERT ANCHOR SUCCESSFULLY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9079631 ↗
• MalfunctionJan 30, 2019Fracture; Fracture

  IT WAS REPORTED THAT SCREW HAS BEEN BROKEN DURING BEGINNING OF THE PROCEDURE. NO CONSEQUENCES FOR THE PATIENT REPORTED. THE PHYSICIAN USED ANOTHER ONE PRODUCT THE SAME TYPE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8288917 ↗
• MalfunctionJan 29, 2019Break; Break

  IT WAS REPORTED THAT AFTER THE ACL GRAFT WAS PREPARED, A TUNNEL WAS PERFORMED IN THE FEMUR, THE GUIDE FOR THE SCREW WAS INSERTED IN THE FEMUR, THE SCREW WAS INSERTED OVER THE NITINOL GUIDE-WIRE AND UPON THE SECOND FEMUR OF THE SCREW USING THE SCREWDRIVER, A CRACK WAS HEARD AND THE SCREW BROKE IN SEVERAL PIECES. THE SURGEON USED A PEEK INTERFERENCE SCREW TO COMPLETE THE PROCEDURE WITH A 30 MINUTE DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8286006 ↗
• MalfunctionJan 29, 2019Fracture; Fracture

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE OF THE KNEE, IT WAS OBSERVED THAT THE MILAGRO ADVANCE SCREW 7X30MM DEVICE BROKE IN THE TIBIA. IT WAS NOT REPORTED IF THERE WAS A DELAY IN THE SURGERY OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. 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 8284839 ↗
• MalfunctionAug 23, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A BTB ANTERIOR CRUCIATE LIGAMENT (ACL) SURGICAL PROCEDURE, IT WAS OBSERVED THAT MILAGRO ADVANCE SCREW, 7X30MM BROKE WHEN BEING INSERTED INTO THE FEMUR. THE SALES REP STATED THAT THE SURGEON USED A 10MM TUNNEL AND THAT THE SCREW CRACKED HORIZONTALLY NEAR MID-BODY BUT CLOSER TO THE NOSE. THE SURGEON WAS ABLE TO REMOVE THE BROKEN PIECES AND COMPLETED THE PROCEDURE USING THE MILAGRO ADVANCE SCREW, 7 X 23MM, IN THE SAME BONE HOLE. THE SALES REP CONFIRMED THERE WAS A FIVE MINUTE DELAY IN THE SURGICAL PROCEDURE. THE SALES REP REPORTED THAT THE SURGEON DID NOT RE PREP THE BONE HOLE AND THAT THE BONE QUALITY WAS NORMAL. 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 7810112 ↗
• MalfunctionJul 24, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP REPORTED THAT DURING A BTB ACL THAT HIS MILAGRO ADVANCE SCREW , 7 X 30MM, BROKE UPON INSERTION. THE SALES REP REPORTED THAT IT BROKE MID-BODY AND THE SURGEON FULLY REMOVED THE DEVICE. THE SURGEON COMPLETED THE PROCEDURE USING A 1ST GENERATION MILAGRO SCREW IN THE SAME BONEHOLE WITH NO PATIENT CONSEQUENCES. THERE WAS NO DELAY IN THE PROCEDURE. THE SALES REP REPORTED THAT THE PATIENT HAS HARD BONE QUALITY. THE SALES REP REPORTED THAT THE SURGEON HAD TAPPED ONLY WHEN PREPPING THE BONEHOLE AND DID NOT RE PREPP THE HOLE FOR THE SECOND IMPLANT. THE TUNNEL SIZE WAS 10MM. THE CUSTOMER ALREADY DISCARDED THE COMPLAINT DEVICE. 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 7715819 ↗
• MalfunctionMay 22, 2018Break; Break

  IT WAS REPORTED BY OUR AFFILIATE THAT DURING AN UNKNOWN PROCEDURE THE SCREW BROKEN OFF WHILE SCREWING IN. IT BROKE INTO FOUR PARTS. THERE IS NO PATIENT HARM OR SURGICAL DELAY REPORTED. NO PARTS REMAIN IN THE BODY, PROCEDURE SUCCESSFULLY FINISHED WITH SAME LIKE PRODUCT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7535096 ↗