MILAGRO 231819Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10886705022236), received between Jun 14, 2018 and Jun 23, 2026 — classified as 4 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 23, 2026Device Damaged Prior to Receipt by User; Material Deformation

  DURING SURGERY DOCTOR USED SCREW DURING THE ACL REPAIR PROCEDURE. UPON OPENING AND INSPECTION OF THE IMPLANT, IT WAS OBSERVED THAT THE THREAD OF THE SCREW APPEARED PARTIALLY BROKEN/DAMAGED. HENCE, THE SCREW COULD NOT BE USED FOR THE PROCEDURE. ANOTHER SCREW WAS SUBSEQUENTLY USED, AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY ISSUE. THERE WAS NO ADVERSE EFFECT ON THE PATIENT. THE CONCERNED IMPLANT IS AVAILABLE FOR INSPECTION. WAS THERE ANY REPORTED PATIENT OR USER HARM? NO. WAS THERE A SIGNIFICANT DELAY? NO IF AVAILABLE, PROVIDE THE PRODUCT ORDER NUMBER (PO). ## ***.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25599386 ↗
• MalfunctionJun 11, 2026Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ANTERIOR CRUCIATE LIGAMENT REPAIR PROCEDURE THE MILAGRO ADVANCE SCREW 10X23MM DEVICE BROKE. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. THE BROKEN SCREWS WERE REMOVED FROM THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A 30 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 25477413 ↗
• MalfunctionDec 29, 2025Delivered as Unsterile Product; Difficult to Advance; Packaging Problem; Delivered as Unsterile Product; Difficult to Advance; Packaging Problem

  IT WAS REPORTED THAT THE MILAGRO ADVANCE SCREW 10 X 23 MM DEVICE FAILED TO INSTALL, PACKAGING WAS DEFECTIVE, STERILE PACKAGING ISSUE -THE BATCH NUMBER CORRESPONDS TO ANOTHER PRODUCT REFERENCE. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23917221 ↗
• MalfunctionDec 15, 2025Crack; Crack

  REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED THAT THE MILAGRO ADVANCE SCREW 8X23MM DEVICE USED ON THE TIBIAL SIDE PLACEMENT TUNNEL WAS TOO TIGHT AND THE SCREW CRACKED AND THE MILAGRO ADVANCE SCREW 10X23MM DEVICE USED ON THE FEMORAL SIDE PLACEMENT TUNNEL WAS TOO TIGHT AND THE SCREW GOT CRACKED. IT WAS REPORTED THAT FRAGMENTS 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 23801001 ↗
• MalfunctionMay 14, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT PROCEDURE, THE MILAGRO ADVANCE SCREW 10X23MM DEVICE HAD THREAD SLIPPAGE (THREADS PEELED) DURING SCREW IMPLANTATION PROCESS. 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 22021753 ↗
• MalfunctionMar 15, 2024Break; Break

  REPORT 4 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 18911164 ↗
• MalfunctionSep 14, 2022Break; Device Contamination with Body Fluid; Device-Device Incompatibility; Break; Device Contamination with Body Fluid; Device-Device Incompatibility

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN COLOMBIA THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE 10X23MM MILAGRO ADVANCE INTERFERENCE SCREW DEVICE GOT CAUGHT IN THE PART OF THE SCREWDRIVER WHEN PASSING; AND THE ONLY WAY TO REMOVE IT WAS BY BREAKING IT. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT UPON VISUAL INSPECTION IT COULD BE OBSERVED THAT THE DEVICE WAS BROKEN AND HAD BIOLOGICAL RESIDUES ON IT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A DELAY OF 10 MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15418889 ↗
• MalfunctionAug 16, 2022Break; Break

  IT WAS REPORTED BY SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE , 10X23MM MILAGRO ADVANCE INTERFERENCE SCREW DEVICE BROKE IN HALF UPON INSERTION INTO THE PATIENT'S BONE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH LESS THAN FIVE MINUTE DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15235199 ↗
• InjuryFeb 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THROUGH CLINICAL RESEARCH REPORT FOR CLINICAL EVIDENCE ON SAFETY AND PERFORMANCE OF MILAGRO ADVANCE SCREW 10X23MM DEVICE THAT POSTOPERATIVELY TO AN INITIAL PROCEDURE OF MEDIAL COLLATERAL LIGAMENT REPAIR PERFORMED ON (B)(6) 2017, THE PATIENT HAD COMPLICATIONS OF POSTOPERATIVE ABNORMAL OR PROLONGED PAIN, POSTOPERATIVE JOINT STIFFNESS AND POSTOPERATIVE ARTHROFIBROSIS ON 05/03/2017. IT WAS FURTHER REPORTED THAT THE PATIENT HAD A REOPERATION PROCEDURE THAT INCLUDED A MUA, PARTIAL LATERAL MENISCECTOMY, LOOSE BODY REMOVAL, AND LYSIS OF ADHESIONS ON (B)(6) 2017 DUE TO ARTHROFIBROSIS. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 13565553 ↗
• InjuryMay 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL RESEARCH REPORT FOR CLINICAL SAFETY AND PERFORMANCE OF MILAGRO ADVANCE BR INTERFERENCE SCREWS IN KNEE COLLATERAL LIGAMENT REPAIRS. FINDINGS ARE AS FOLLOWS: PATIENT #4 , DATE OF SURGERY: (B)(6) 2017. MEDIAL COLLATERAL LIGAMENT REPAIR. MILAGRO ADVANCE BR 231819 RIGHT 22 FEMALE . DATE OF INJURY: (B)(6) 2016 . REASON FOR INJURY: SPORTS . POSTOPERATIVE ARTHROFIBROSIS: YES (B)(6) 2017. COMPLICATION: PATIENT HAD TIBIAL EMINENCE FRACTURE. RE-OPERATION: MEDIAL COLLATERAL LIGAMENT REPAIR (B)(6) 2017. ARTHROFIBROSIS; ACL TEAR; LATERAL MENISCUS TEAR; KNEE LOOSE BODIES, MUA (MANIPULATION UNDER ANESTHESIA), PARTIAL LATERAL MENISCECTOMY, LOOSE BODY REMOVAL, LYSIS OF ADHESIONS, ACL RECONSTRUCTION.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11871912 ↗
• InjuryAug 14, 2019Migration; Migration

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN ACL PROCEDURE THEIR INTRAFIX ADVANCE BR SCREW 10 X 30 MM WITH LARGE SHEATH WHEN THE SCREW WAS INSERTED INTO THE SHEATH, THE SHEATH DID NOT HOLD IN THE PATIENT. WHEN THEY TRIED THEIR 10 X 23 MM MILAGRO ADVANCE INTERFERENCE SCREW THAT ALSO DID NOT HOLD IN THE PATIENT. THE PROCEDURE WAS COMPLETE WITH A COMPETITOR'S DEVICE WITH A NEW BONE HOLE CREATED. THERE WAS NO PATIENT CONSEQUENCES BUT THERE WAS A 20 MINUTE SURGICAL DELAY TO THE CASE. THE SALES REP STATED THAT THE PATIENT WAS AN OLDER PERSON WITH SOFT BONE QUALITY. THE SALES REP STATED THAT THE DEVICES WERE DISCARDED BY THE CUSTOMER. THIS REPORT IS FOR ONE (1) MILAGRO ADVANCE SCREW 10 X 23 MM. THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8895287 ↗
• InjuryNov 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT THE SURGEON COMPLAINED ABOUT THE MILAGRO ADVANCE SCREW DEVICE WHICH SEEMED TO MAKE HOLES INTO THE FEMORAL CONDYLE BONE IN CRUCIAL LIGAMENT REPLACEMENT. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. IT WAS NOT REPORTED IF THERE WERE MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN BUT WAS NOTED TO HAVE OCCURRED IN 2018. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Injury

  MAUDE report 8069242 ↗
• MalfunctionJun 14, 2018Crack; Crack

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN ACL PROCEDURE THE NEW TECH HANDED THE SURGEON A 33MM DRIVER TO INSERT THE CUSTOMER'S MILAGRO ADVANCE SCREW 9X23MM AND THE SCREW CRACKED. THE ISSUE OCCURRED AGAIN WITH THE CUSTOMER'S MILAGRO ADVANCE SCREW 10X23MM. THE SALES REP STATED THAT THE SURGEON WAS ABLE TO BACK OUT BOTH DEVICES WITH NO ISSUES AND THAT BOTH DEVICES DID NOT BREAK INTO TWO OR MORE PIECES. THE PROCEDURE WAS COMPLETED WITH OTHER LIKE DEVICES USING THE SAME HOLE WITH NO HARM TO THE PATIENT OR DELAYS TO THE CASE. THE SALES REP STATED THAT THE DEVICES WERE DISCARDED BY THE CUSTOMER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7601604 ↗