MILAGRO 231814Recalls & reported problems

Summary

The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 10886705021963), received between Apr 23, 2018 and Jun 11, 2026 — classified as 1 injury, 57 malfunctions.

The most frequently reported specific device problem is “Break” (54 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 58 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 11, 2026Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED ARTHROSCOPIC PROCEDURE THE 5X12 MILAGRO INTERERENCE SCREW 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25477885 ↗
• MalfunctionApr 24, 2026Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC LIGAMENT REPAIR SURGERY, THE SCREW (5X12 MILAGRO INTERERENCE SCREW) BROKE. 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 24981548 ↗
• MalfunctionMar 13, 2026Break

  IT WAS REPORTED THAT DURING AN UNKNOWN ARTHROSCOPIC PROCEDURE THAT THE 5X12 MILAGRO INTERERENCE SCREW DEVICE BROKE DURING INSERTION. ALL THE PIECES WERE REMOVED FROM THE PATIENT. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24590568 ↗
• MalfunctionMar 10, 2026Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE, THE 5X12 MILAGRO INTERERENCE SCREW SURGEON TRIED TO INSERT THE SCREW INTO THE BONE, IT BROKE AND BECAME UNSTABLE. IT SEEMED TO HAVE LACKED STRENGTH. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT USING DIFFERENT PRODUCT. NO REMAINS WERE LEFT INSIDE THE BODY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24561258 ↗
• MalfunctionJan 2, 2026Break

  THIS IS REPORT 4 OF 4 FOR (B)(4). IT WAS REPORTED THAT DURING ARTHROSCOPY PROCEDURE, IT WAS DISCOVERED THAT THE MILAGRO INTERFRENCE SCREW DEVICE BROKE. ALL THE BROKEN PARTS WERE REMOVED FROM THE PATIENT. THREE REPLACEMENT DEVICES WERE USED TO CONTINUE THE SURGERY, BUT THE SAME ISSUE OCCURRED AGAIN. 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 23944910 ↗
• MalfunctionJan 2, 2026Break

  THIS IS REPORT 3 OF 4 FOR (B)(4). IT WAS REPORTED THAT DURING ARTHROSCOPY PROCEDURE, IT WAS DISCOVERED THAT THE MILAGRO INTERFRENCE SCREW DEVICE BROKE. ALL THE BROKEN PARTS WERE REMOVED FROM THE PATIENT. THREE REPLACEMENT DEVICES WERE USED TO CONTINUE THE SURGERY, BUT THE SAME ISSUE OCCURRED AGAIN. 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 23944908 ↗
• MalfunctionJan 2, 2026Break

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, IT WAS DISCOVERED THAT WHEN THE 5X12 MILAGRO INTERERENCE SCREW DEVICE WAS INSERTED, IT BROKE OFF. ALL THE BROKEN PARTS WERE REMOVED FROM THE PATIENT. A REPLACEMENT DEVICE WAS USED TO CONTINUE THE SURGERY, BUT THE SAME ISSUE OCCURRED AGAIN. 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. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN JUNE 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23943828 ↗
• MalfunctionJan 2, 2026Break

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, IT WAS DISCOVERED THAT WHEN THE 5X12 MILAGRO INTERERENCE SCREW DEVICE WAS INSERTED, IT BROKE OFF. ALL THE BROKEN PARTS WERE REMOVED FROM THE PATIENT. A REPLACEMENT DEVICE WAS USED TO CONTINUE THE SURGERY, BUT THE SAME ISSUE OCCURRED AGAIN. 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. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN JUNE 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23943816 ↗
• MalfunctionJul 9, 2025Break; Break

  IT WAS REPORTED THAT DURING A LIGAMENT RECONSTRUCTION SURGICAL PROCEDURE IT WAS OBSERVED THAT THE 5X12 MILAGRO INTERERENCE SCREW DEVICE ANCHOR BROKE OFF. 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 22461165 ↗
• MalfunctionJul 7, 2025Detachment of Device or Device Component; Migration; Detachment of Device or Device Component; Migration

  IT WAS REPORTED THAT DURING AN ANKLE RECONSTRUCTION SURGERY, IT WAS OBSERVED THAT THE 5X12 MILAGRO INTERERENCE SCREW DEVICE WAS PULLED OUT OF THE BONE TUNNEL. 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 22412033 ↗
• MalfunctionMay 23, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGICAL PROCEDURE, THE 5X12 MILAGRO INTERERENCE SCREW 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 22077813 ↗
• MalfunctionDec 31, 2024Break; Break

  REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE MILAGRO INTERERENCE SCREW DEVICE ANCHOR WAS BROKEN OFF. ALL THE BROKEN PARTS WERE REMOVED. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21047370 ↗
• MalfunctionDec 31, 2024Break; Break

  REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE MILAGRO INTERERENCE SCREW DEVICE ANCHOR WAS BROKEN OFF. ALL THE BROKEN PARTS WERE REMOVED. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21047368 ↗
• MalfunctionDec 31, 2024Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THE 5X12 MILAGRO INTERFERENCE SCREW DEVICE ANCHOR WAS BROKEN OFF. IT WAS REPORTED THAT 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 COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21047065 ↗
• MalfunctionDec 5, 2024Break; Break

  IT WAS REPORTED THAT DURING A LIGAMENT RECONSTRUCTION SURGICAL PROCEDURE THE 5X12 MILAGRO INTERERENCE SCREW DEVICE ANCHOR WAS BROKEN OFF. ALL BROKEN PARTS WERE REMOVED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20858002 ↗
• MalfunctionNov 21, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ANKLE FUSION OSTEOTOMY SURGICAL PROCEDURE THE MILAGRO INTERERENCE SCREW DEVICE ANCHOR WAS BROKEN OFF. 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 COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20745805 ↗
• MalfunctionOct 30, 2024Break; Break

  IT WAS REPORTED FROM (B)(6) THAT DURING A LIGAMENT RECONSTRUCTION PROCEDURE, IT WAS DISCOVERED THAT THE ANCHOR ON THE 5X12 MILAGRO INTERFERENCE SCREW 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. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN (B)(6) 2024. 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 20568885 ↗
• MalfunctionOct 30, 2024Break; Break

  IT WAS REPORTED FROM CHINA THAT DURING A LIGAMENT RECONSTRUCTION PROCEDURE, IT WAS DISCOVERED THAT THE ANCHOR ON THE 5X12 MILAGRO INTERFERENCE SCREW 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. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN (B)(6) 2024. 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 20568637 ↗
• MalfunctionAug 28, 2024Break; Break

  IT WAS REPORTED FROM CHINA THAT DURING AN ARTHROSCOPIC CARTILAGE AND LIGAMENT REPAIR SURGERY FOR THE RIGHT ANKLE, THE UNSPECIFIED SURGICAL PROCEDURE THE 5X12 MILAGRO INTERERENCE SCREW DEVICE ANCHOR WAS BROKEN OFF. ALL BROKEN PARTS 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 20086088 ↗
• MalfunctionJul 12, 2024Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A RECONSTRUCTION OF THE TALOFIBULAR LIGAMENT SURGICAL PROCEDURE ON(B)(6)2024 THE 5X12 MILAGRO INTERERENCE SCREW DEVICE ANCHOR WAS BROKEN. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19731140 ↗
• MalfunctionMay 22, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT PROCEDURE, THE 5X12 MILAGRO INTERERENCE SCREW 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 19369746 ↗
• MalfunctionApr 25, 2024Break; Break

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN CHINA THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2024, IT WAS OBSERVED THAT THE 5X12 MILAGRO INTERFERENCE SCREW DEVICE ANCHOR WAS BROKEN OFF, REMOVED ALL THE BROKEN PARTS. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE 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 19179455 ↗
• MalfunctionMar 15, 2024Break; Break

  REPORT 2 OF 4 FOR (B)(4). IT WAS REPORTED BY SALES REP THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2024, IT WAS OBSERVED THAT A 8X15MM MILAGRO INTERFERENCE SCREW, 5X12MM MILAGRO INTERFERENCE SCREW, 8X23MM MILAGRO ADVANCE INTERFERENCE SCREW AND 10X23MM MILAGRO ADVANCE INTERFERENCE SCREW DEVICES WERE BROKEN. IT WAS REPORTED THAT THE PATIENT HAD EXTREMELY HARD BONE, AND IT WAS A REVISION CASE. IT WAS REPORTED THAT THE SAME LARGE TUNNELS WERE USED AND THE DOCTOR WANTED TO START WITH A LARGER SCREW BUT IT WOULD NOT DRIVE EVEN AFTER NOTCHING AND TAPPING FOUR TIMES. ACCORDING TO THE REPORTER, MULTIPLE SCREWS WERE TRIED, THEY ALL ENDED UP BREAKING AND THE BROKEN SCREW STAYED INSIDE THE PATIENT AS IT WASN'T BADLY BROKEN SINCE IT WAS STILL HOLDING THE GRAFT IN PLACE. IT WAS REPORTED THAT THE DOCTOR LEFT THE LEFT BROKEN SCREW INSIDE PATIENT AS IT HELD THE GRAFT BUT BROKE IN HALF. 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 18911215 ↗
• MalfunctionMar 6, 2024Break; Break

  IT WAS REPORTED BY THE SALES REP IN CHINA THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) RECONSTRUCTION SURGICAL PROCEDURE ON (B)(6) 2024 IT WAS OBSERVED THAT THE 5X12 MILAGRO INTERERENCE SCREW DEVICE WAS BROKEN OFF. IT WAS REPORTED THAT ALL BROKEN PARTS WERE REMOVED. IT WAS REPORTED THAT 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 18846567 ↗
• MalfunctionJan 23, 2024Break; Break

  IT WAS REPORTED FROM CHINA BY THE SALES REP THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2023 THE MILAGRO INTERERENCE SCREW DEVICE ANCHOR 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 COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18563120 ↗