MILAGRO 231813Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10886705021956), received between Jul 26, 2018 and May 5, 2026 — classified as 23 malfunctions.

The most frequently reported specific device problem is “Break” (22 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 5, 2026Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC KNEE PROCEDURE THE 6X12 MILAGRO INTERFRENCE SCREW 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 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25086026 ↗
• 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 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25071695 ↗
• MalfunctionJan 6, 2026Break

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, THE 6X12 MILAGRO INTERFRENCE 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 COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23977179 ↗
• MalfunctionJan 2, 2026Break

  THIS IS REPORT 1 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 23944919 ↗
• MalfunctionJan 2, 2026Break

  THIS IS REPORT 2 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 23944918 ↗
• MalfunctionAug 21, 2025Break; Break

  IT WAS REPORTED THAT THE 2X 6X12 MILAGRO INTERFRENCE SCREW DEVICE WERE BROKE. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. THIS IS REPORT 1 OF 2 OF (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22864792 ↗
• MalfunctionAug 21, 2025Break; Break

  IT WAS REPORTED THAT THE 2X 6X12 MILAGRO INTERFRENCE SCREW DEVICE WERE BROKE. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. THIS IS REPORT 2 OF 2 OF (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22864645 ↗
• MalfunctionJul 15, 2025Break; Break

  IT WAS REPORTED THAT DURING A RECONSTRUCTION OF AN ANTERIOR CRUCIATE LIGAMENT SURGICAL PROCEDURE IT WAS OBSERVED THAT THE 6X12 MILAGRO INTERFRENCE SCREW DEVICE ANCHOR WAS BROKEN OFF. ALL BROKEN PARTS WERE REMOVED. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. 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. THIS IS REPORT 1 OF 2 OF (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22516241 ↗
• MalfunctionJul 15, 2025Break; Break

  IT WAS REPORTED THAT DURING A RECONSTRUCTION OF AN ANTERIOR CRUCIATE LIGAMENT SURGICAL PROCEDURE IT WAS OBSERVED THAT THE 6X12 MILAGRO INTERFERENCE SCREW DEVICE ANCHOR WAS BROKEN OFF. ALL BROKEN PARTS WERE REMOVED. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. 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. THIS IS REPORT 2 OF 2 OF (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22516240 ↗
• MalfunctionMay 6, 2025Break; Break

  IT WAS REPORTED THAT DURING A MEDIAL MENISCUS POSTERIOR ROOT TEAR SURGERY, IT WAS OBSERVED THAT THE 6X12 MILAGRO INTERFRENCE SCREW DEVICE IMPLANT BROKE DURING INSERTION. IT WAS REPORTED THAT NO BROKEN PIECES WERE LEFT INSIDE THE PATIENT. 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 21968765 ↗
• MalfunctionAug 15, 2023Break; Break

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN CHINA THAT DURING AN ANKLE RECONSTRUCTION PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE 6X12MM MILAGRO INTERFERENCE SCREW 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 17550702 ↗
• MalfunctionSep 8, 2021Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ORTHOPEDIC PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE 6X12 MILAGRO INTERFRENCE SCREW BROKE AS THE SURGEON TORQUED IT USING A DRIVER TO WIGGLE IT AROUND FOR INSERTION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT DELAY. 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 12441126 ↗
• MalfunctionMar 25, 2021Break; Break

  IT WAS REPORTED BY THE SALES REP IN SWITZERLAND THAT DURING AN ANTERIOR CRUCIATE LIGAMENT PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE SCREW DEVICE BROKE AS IT WAS BEING INSERTED INTO THE BONE. ALL FRAGMENTS WERE REMOVED. THE ACL WAS STABLE EVEN THE SCREW WAS BROKEN. THERE WAS A DELAY OF APPROXIMATELY TWO MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11570135 ↗
• MalfunctionMar 25, 2021Break; Break

  IT WAS REPORTED BY THE SALES REP IN (B)(6) THAT DURING A KNEE ARTHROSCOPY PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE TIP ON THE SCREW DEVICE BROKE WHILE IT WAS BEING INSERTED INTO THE BONE WITHOUT PRESSURE. THE FRAGMENTS WERE EASILY REMOVED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A DELAY OF TWO MINUTES. THE ACL WAS STABLE EVEN WHILE THE SCREW WAS BROKEN. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11570112 ↗
• MalfunctionJan 7, 2020Break; Break

  IT WAS REPORTED BY THE SALES REP VIA CST THAT THE MILAGRO INTERFERENCE SCREW BROKE IN HALF DURING INSERTION. A 5 MINUTE DELAY WAS REPORTED. ALL FRAGMENTS GENERATED WERE SUCCESSFULLY REMOVED FROM THE BODY OF THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: Not Applicable

  MAUDE report 9560651 ↗
• MalfunctionDec 3, 2019Break; Break

  IT WAS REPORTED BY THE AFFILIATE VIA THE COMPLAINT SUBMISSION TOOL, THAT DURING AN ACL REPAIR THE SURGEON WAS CONNECTING THE 12MM SCREWDRIVER WITH THE SCREW, THE SCREW BROKE IN THE MIDDLE OF THE LENGTH. THE AFFILIATE REPORTED A SURGICAL DELAY DID NOT OCCUR AND FRAGMENTS WERE NOT GENERATED. IT WAS ALSO REPORTED ADDITIONAL SURGICAL INTERVENTION WAS NOT REQUIRED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED BUT ADDITIONAL DETAILS COULD NOT BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9404767 ↗
• MalfunctionDec 3, 2019Break; Break

  IT WAS REPORTED BY THE AFFILIATE VIA THE COMPLAINT SUBMISSION TOOL, THAT DURING AN ACL REPAIR THE SURGEON WAS CONNECTING THE 12MM SCREWDRIVER WITH THE SCREW, THE SCREW BROKE IN THE MIDDLE OF THE LENGTH. THE AFFILIATE REPORTED A SURGICAL DELAY DID NOT OCCUR AND FRAGMENTS WERE NOT GENERATED. IT WAS ALSO REPORTED ADDITIONAL SURGICAL INTERVENTION WAS NOT REQUIRED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED BUT ADDITIONAL DETAILS COULD NOT BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9404004 ↗
• MalfunctionNov 22, 2019Break; Break

  THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING THE PROCEDURE OF AN ANKLE LIGAMENT RECONSTRUCTION, IT WAS OBSERVED THAT THE 6X12 MILAGRO INTERFRENCE SCREW WAS BROKEN OFF INTO TWO PIECES UPON SCREWING. IT WAS REPORTED THAT THE PIECES WERE REMOVED FROM THE PATIENT. IT WAS REPORTED THAT THE SAME THING HAPPENED WHEN SCREWING THE MILAGRO INTSCR 7X23MM *EA WHICH WAS BROKEN OFF INTO TWO PIECES. IT WAS REPORTED THAT ONE OF THE PIECES WAS NOT ABLE TO BE REMOVED BECAUSE IT WAS INSERT INTO THE BONE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY WAS REPORTED. THERE WAS NO DELAY IN THE SURGICAL PROCEDURE. THERE WAS A SPARE DEVICE AVAILABLE FOR USE TO COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT. 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 WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9363156 ↗
• MalfunctionNov 2, 2018Break; Break

  ADDITIONAL INFORMATION RECEIVED FROM SALES REPRESENTATIVE ON (B)(6) 2018: THE LOT NUMBER WAS PROVED AS 3914932; HOWEVER, THE CONSIGNMENT TEAM INDICATED THE LOT PROVIDED WAS INVALID. THERE WERE NO PROCEDURAL OR PATIENT ANATOMY FACTORS WHICH MAY HAVE CONTRIBUTED TO THE BREAKAGE. THE PATIENT¿S BONE QUALITY WAS NOTED AS NORMAL. THE INSERTION WAS NOT OFF AXIS. THE SAME BONE HOLE WAS USED TO COMPLETE THE PROCEDURE. THE TUNNEL AND GRAFT SIZE WERE SIX MILLIMETERS (6MM). NO TRIALING WAS PERFORMED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8033071 ↗
• MalfunctionSep 18, 2018Crack; Crack

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ACL PROCEDURE, IT WAS OBSERVED THAT THE INSERTER WAS NOT IN ALL THE WAY TO THE LASER LINE CAUSING THEIR MILAGRO INTERFERENCE SCREW 6X12MM TO CRACK. THE SALES REP STATED THAT THE SURGEON REMOVED THE SCREW AND DEBRIS FROM THE PATIENT WITH NO ISSUES. THE SALES REP REPORTED THAT THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER LIKE DEVICE USING THE SAME BONE HOLE WITH NO PATIENT CONSEQUENCES OR DELAYS. THE SALES REP STATED THAT THE PATIENT'S BONE QUALITY WAS GOOD. THE SALES REP STATED THAT THE DEVICE BREAKING WAS MORE DUE TO THE DOCTOR'S TECHNIQUE AND NOT THE DEVICE ITSELF. THE SALES REP STATED THAT THE DEVICE WAS DISCARDED. 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 7884789 ↗
• MalfunctionAug 23, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A KIDNEY SURGERY OF MCL SOFT TISSUE REPAIR, IT WAS OBSERVED THAT THE TIP BROKE OFF OF HIS MILAGRO INTERFACE SCREW 6 X 12MM UPON INSERTION INTO VERY HARD BONE. THE SALES REP REPORTED THAT THE SURGEON WAS OFF ANGLE, DID NOT TAP, AND DID NOT INSERT THE DRIVER ALL THE WAY. THE SURGEON COMPLETELY REMOVED THE BROKEN IMPLANT. THE SURGEON COMPLETED THE PROCEDURE WITH A LARGER SCREW IN THE SAME BONEHOLE WITH NO PATIENT CONSEQUENCES OR DELAYS. 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 7808663 ↗
• MalfunctionAug 6, 2018Break; Break

  IT WAS REPORTED THAT THE SCREW BROKE IN UNKNOWN PROCEDURE. THE BROKEN PIECE WAS RETRIEVED FROM PATIENT. CHANGED NEW ONE TO COMPLETE. THERE WAS NO ADVERSE EVENT ON PATIENT REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7755395 ↗
• MalfunctionJul 26, 2018Break; Break

  IT WAS REPORTED THAT UPON INSERTION OF MILAGRO 6X12 INTERFERENCE SCREW, THE SCREW BROKE. DOCTOR USED AN ADDITIONAL MILAGRO 6X12 INTERFERENCE SCREW AND IT STAYED INTACT. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7724312 ↗