MILAGRO 231816Recalls & reported problems

Summary

The FDA's MAUDE database contains 127 adverse event reports that list this exact device (DI 10886705022243), received between Feb 6, 2018 and Jul 28, 2026 — classified as 8 injuries, 119 malfunctions.

The most frequently reported specific device problem is “Break” (82 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 127 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 28, 2026Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50052077 ↗
• MalfunctionJul 28, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50051642 ↗
• MalfunctionJun 16, 2026Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE MILAGRO ADVANCE SCREW 7X23MM DEVICE BROKE. IT WAS REPORTED THAT THERE WAS A 2-MINUTE DELAY IN THE PROCEDURE DUE TO THE EVENT. THERE WERE NO REPORTS OF INJURIES OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS NOT REPORTED; HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25526122 ↗
• MalfunctionJun 4, 2026Break

  IT WAS REPORTED THAT DURING THE ANTERIOR CRUCIATE LIGAMENT) (ACL) REPAIR SURGERY, THE MILAGRO ANCHOR WAS BROKEN. ALL BROKEN PRODUCT WAS 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 25394971 ↗
• MalfunctionMay 4, 2026Break

  IT WAS REPORTED THAT DURING KNEE JOINT SURGERY, THE MILAGRO SCREW WAS BROKEN. ALL THE BROKEN PARTS WERE REMOVED. CHANGED TO ANOTHER MILAGRO SCREW TO CONTINUE THE SURGERY 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 WAS PROVIDED. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25071912 ↗
• MalfunctionApr 22, 2026Break

  THIS IS REPORT 1 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 24953022 ↗
• MalfunctionApr 21, 2026Difficult to Advance

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, WHEN DRILLING A BONE HOLE TO THE 25MM MARK WITH A 7MM REAMER AND INSERTING A MILAGRO ADVANCE 7X23, IT SLIPPED FREELY AND STOPPED MIDWAY. THEY THEN INSERTED A 7X15MM AND REPORTED THAT THE OPERATION WAS SUCCESSFULLY COMPLETED. THERE WERE NO SURGICAL DELAYS AND NO HARM TO THE PATIENT. THE DEVICE WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24938498 ↗
• MalfunctionApr 1, 2026Crack

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ANTERIOR CRUCIATE LIGAMENT REPAIR PROCEDURE THAT THE MILAGRO ADVANCE SCREW 7X23MM DEVICE TWO MILAGRO ADVANCE SCREWS CRACKED UPON INSERTION INTO THE FEMORAL TUNNEL IN AN ACL RECONSTRUCTION. OPENED NEW SCREW AND SAME RESULT HAPPENED AS THE FIRST ONE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A 4 MINUTE 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 24757972 ↗
• MalfunctionApr 1, 2026Crack

  THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24757971 ↗
• MalfunctionMar 25, 2026Difficult to Advance; Mechanical Jam

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE THAT THE MILAGRO ADVANCE SCREW 7X23MM DEVICE JAMMED MIDWAY AND DID NOT GO ALL THE WAY IN. CONSIDERING THE RISK OF DAMAGE DURING USE, THIS PRODUCT WAS NOT USED. 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 24691579 ↗
• MalfunctionMar 2, 2026Break

  IT WAS REPORTED THAT DURING ANTERIOR CRUCIATE LIGAMENT SURGERY, THE SCREW OF THE MILAGRO ADVANCE SCREW 7X23MM 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 WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24481405 ↗
• MalfunctionFeb 8, 2026Break

  THIS IS REPORT 3 OF 4 OF (B)(4). IT WAS REPORTED THAT DURING A JOINT SURGICAL PROCEDURE IT WAS OBSERVED THAT THE OMNISPAN MENISCAL REPAIR 12DEG DEVICE SCREW BROKE OFF AND DOUBLE DEPLOYED. WHEN THE SCREW WAS INSERTED IT BROKE. ALL BROKEN PARTS WERE RETRIEVED. THE USER CHANGED TO ANOTHER DEVICE TO CONTINUE THE PROCEDURE. AFTER FIRST FIRING, TWO PLATES WERE DEPLOYED AT THE SAME TIME. THE USER CHANGED TO ANOTHER SCREW AND MENISCAL DEVICE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. ANOTHER SCREW AND MENISCAL DEVICE WERE USED TO COMPLETE THE SURGERY. THERE WERE NO REPORTS OF A DELAY TO 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 24288524 ↗
• MalfunctionFeb 3, 2026Break

  THIS IS REPORT 2 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 (B)(6) 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24251067 ↗
• MalfunctionDec 19, 2025Break; Device-Device Incompatibility; Mechanical Jam; Break; Device-Device Incompatibility; Mechanical Jam

  IT WAS REPORTED THAT DURING A LONG HEAD OF BICEPS (LHB) FIXATION ON THE SHOULDER, AFTER ATTACHING THE MILAGRO ADVANCE SCREW 7X23MM DEVICE TO THE 23MM LARGE MILAGRO DRIVER AND INSERTING IT INTO THE BONE TUNNEL, AN ISSUE OCCURRED WHERE THE DRIVER BECAME STUCK AND COULD NOT BE REMOVED FROM THE SCREW DEVICE. THE SURGEON REMOVED THE MILAGRO SCREW AND DRIVER FROM THE BONE TUNNEL AND ATTEMPTED TO REMOVE IT FROM THE DRIVER OUTSIDE THE BODY, BUT IT WAS STUCK TIGHTLY AND COULD NOT BE MOVED, SO HE BROKE THE MILAGRO AND REMOVED IT FROM THE DRIVER. A NEW DEVICE OF THE SAME SIZE WAS USED. THERE WAS NO RESIDUE REMAINING INSIDE THE BODY. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23856570 ↗
• MalfunctionDec 5, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT REPAIR PROCEDURE, WHILE INSERTING THE MILAGRO ADVANCE SCREW 7X23MM DEVICE INTO THE FEMORAL TUNNEL THE SCREW BROKE DESPITE A MILAGRO NOTCHER HAVING BEEN USED BEFOREHAND. 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 23728294 ↗
• MalfunctionNov 25, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE AFTER PLACING THE INTRAFX ADVBR SCW8X30 W/SMSHTH DEVICE IT WAS OBSERVED THAT THE SCREW BROKE. THE SCREW WAS PARTIALLY REMOVED AND A MILAGRO ADVANCE SCREW 7X23MM DEVICE WAS ADVANCED AND PLACED AND WAS ALSO BELIEVED TO HAVE PARTLY BROKE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23649271 ↗
• MalfunctionNov 25, 2025Crack; Crack

  IT WAS REPORTED THAT THE MILAGRO ADVANCE SCREW 7X23MM CRACKED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23649023 ↗
• MalfunctionOct 31, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) SURGICAL PROCEDURE IT WAS OBSERVED THAT THE TIP OF THE MILAGRO ADVANCE SCREW 7X23MM ANCHOR DEVICE WAS BROKEN OFF. IT WAS REPORTED THAT ALL BROKEN PIECES WERE REMOVED. 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 23438420 ↗
• MalfunctionOct 22, 2025Break; Break

  IT WAS REPORTED THAT DURING A LIGAMENT REPAIR PROCEDURE, IT WAS DISCOVERED THAT THE ANCHOR ON THE MILAGRO ADVANCE SCREW 7X23MM 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. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN OCTOBER 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23358866 ↗
• MalfunctionAug 22, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGICAL PROCEDURE, THE MILAGRO ADVANCE SCREW 7X23MM DEVICE THE SCREW WHILE INSERTING THE TIP WAS BROKEN OFF. NO SURGICAL DELAY OR PATIENT HARM. THE EXACT DATE OF THIS EVENT WAS UNKNOWN BUT WAS NOTED TO HAVE OCCURRED IN 2025. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22874504 ↗
• MalfunctionAug 18, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT WHILE INSERTING THE MILAGRO ADVANCE SCREW FOR THE FEMORAL TUNNEL IT WAS OBSERVED THAT IT WAS BROKEN. A BTB GRAFT WAS USED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTS OF DELAY TO 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 22827539 ↗
• MalfunctionMay 28, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR PROCEDURE, THE UNSPECIFIED SURGICAL PROCEDURE THE MILAGRO ADVANCE SCREW 7X23MM DEVICE WAS BEING USED WHEN THE LHB STUMP WAS INSERTED INTO THE BONE HOLE DISTAL TO THE INTERTUBERCULAR GROOVE TOGETHER WITH THE PRODUCT IN QUESTION, THE PRODUCT BROKE AND WAS REMOVED. A NEW PRODUCT WAS OPENED AND DEPLOYMENT WAS COMPLETED WITHOUT AN ISSUE. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22094875 ↗
• MalfunctionMar 19, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT REPAIR (ACL) 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. THERE WAS PATIENT INVOLVEMENT. 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 21643283 ↗
• MalfunctionFeb 21, 2025Break; Break

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE, IT WAS OBSERVED THAT TWO MILAGRO ADVANCE SCREW 7X23MM DEVICES SHATTERED INSIDE THE JOINT AFTER TAPPING THE FEMUR WITH APPROPRIATE TAP AND CONFIRMING BONE HARDNESS. THE BROKEN FRAGMENTS WERE REMOVED. ANOTHER LIKE DEVICES WERE USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH AN UNSPECIFIED DELAY. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21433575 ↗
• MalfunctionFeb 21, 2025Break; Break

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE, IT WAS OBSERVED THAT TWO MILAGRO ADVANCE SCREW 7X23MM DEVICES SHATTERED INSIDE THE JOINT AFTER TAPPING THE FEMUR WITH APPROPRIATE TAP AND CONFIRMING BONE HARDNESS. THE BROKEN FRAGMENTS WERE REMOVED. ANOTHER LIKE DEVICE WERE USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH AN UNSPECIFIED DELAY. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21433574 ↗