MILAGRO 231824Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886705022298), received between Nov 15, 2019 and Jul 14, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 14, 2025Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE MILAGRO ADVANCE SCREW DEVICE THE BURR HOLE BECAME LARGER THAN EXPECTED. THE SURGEON SELECTED THE BIGGER SIZE SCREWS, BUT THEY ONLY WENT HALFWAY. THEREFORE, THE SURGEON HAD TO REPEATEDLY REDUCE THE SIZE OF THE SCREWS. THE BONE WAS NOT PARTICULARLY HARD. THE SURGERY WAS COMPLETED SUCCESSFULLY USING A DIFFERENT SIZE OF SCREWS. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. NO FOREIGN OBJECTS WERE LEFT IN THE BODY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 2 OF 2 OF (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22498294 ↗
• MalfunctionAug 3, 2023Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN COLOMBIA THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON 7/11/2023, IT WAS OBSERVED THAT THE 11X30MM MILAGRO ADVANCE INTERFERENCE SCREW DEVICE BROKE WHEN ENTERING THE TIBIAL TUNNEL THEN REMOVED ALL THE BROKEN FRAGMENTS. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A DELAY OF 30 MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS COMPLAINT INVOLVES X (X) DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17451398 ↗
• MalfunctionNov 15, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED BY THE AFFILIATE VIA COMPLAINT SUBMISSION TOOL THAT DURING AND ACL CASE THE PINS OF THE ABSOLUTE G-W NTNL 1.1MMX15 6PK BROKE, THE BROKEN TIP WAS TRAPPED IN THE GRAFT AND THE SURGEON HAD TO REMOVE THE MILAGRO ADVANCE SCREW 11X30MM AND THE CORTICAL FXATION FXD LOOP 15MM FROM FEMORAL SIDE IN ORDER TO TAKE THE GRAFT OUT AND LOOKED FOR THE WIRE TIP, THE GUIDE WIRE TIP WAS FOUND AND WAS REMOVED FROM THE PATIENT, BUT THE SCREW WAS A LITTLE DEFORMED. THE PROCEDURE WAS COMPLETED USING DIFFERENT DEVICES. NO PATIENT CONSEQUENCE WAS REPORTED. HOWEVER, THERE WAS A SURGICAL DELAY REPORTED. ADDITIONAL INFORMATION RECEIVED FROM THE AFFILIATE REPORTED A 30 MINUTE SURGICAL DELAY. THE AFFILIATE ALSO REPORTED ONLY ONE FRAGMENT WAS GENERATED AND IT WAS SUCCESSFULLY REMOVED BY THE SURGEON. IT WAS ALSO REPORTED THE BROKEN TIP WAS TRAPPED IN THE GRAFT AND SURGEONS NEED TO REMOVE THE 231824 AND 15MM RIGIDLOOP 232009 X1 (LOT 4L23984) AT FEMORAL SIDE IN ORDER TO TAKE THE GRAFT OUT AND SEARCH FOR THE GUIDE WIRE TIP. THE AFFILIATE REPORTED THAT NORMAL FORCE WAS APPLIED TO REMOVE THE SCREW.

  Patient problems: Not Applicable

  MAUDE report 9331041 ↗