MILAGRO 231803Recalls & reported problems

Summary

The FDA's MAUDE database contains 84 adverse event reports that list this exact device (DI 10886705010714), received between Jul 23, 2018 and Sep 4, 2026 — classified as 3 injuries, 81 malfunctions.

The most frequently reported specific device problem is “Break” (79 reports).

5 other recalls cover devices cleared under the same FDA submission (K103831, K150209); they may or may not involve this specific model.

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 25 most recent of 84 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 4, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50612110 ↗
• MalfunctionAug 26, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50460660 ↗
• MalfunctionAug 19, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50322669 ↗
• MalfunctionMay 27, 2026Break

  IT WAS REPORTED THAT DURING RECONSTRUCTION OF MEDIAL PATELLAR LIGAMENT SURGERY, THE MILAGRO SCREW DEVICE AND THE HEALIX ADVANCE ORTHOCORD ANCHOR DEVICE WERE 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. REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25306042 ↗
• MalfunctionMay 26, 2026Difficult to Advance

  IT WAS REPORTED THAT THIS WAS AN ANTERIOR CRUCIATE LIGAMENT (ACL) RECONSTRUCTION SURGERY, WHILE USING THE MILAGRO DEVICE FOR GRAFT FIXATION, WHEN THE SURGEON TRIED TO FIX THE GRAFT USING THE MILAGRO DEVICE, AFTER PASSING IT THROUGH A BONE TUNNEL SUFFICIENT FIXATION WAS NOT ACHIEVED. HOWEVER, BY INCREASING THE SIZE OF THE MILAGRO, SUFFICIENT FIXATION WAS ACHIEVED. 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 25279190 ↗
• MalfunctionMay 21, 2026Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED ARTHROSCOPIC PROCEDURE THE MILAGRO INSCR SMALL SIZE 5X23 ANCHOR DEVICE BROKE. 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 25246238 ↗
• MalfunctionMay 21, 2026Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED ARTHROSCOPIC PROCEDURE THE MILAGRO INSCR SMALL SIZE 5X23 DEVICE BROKE. 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 25245586 ↗
• MalfunctionMay 21, 2026Break

  IT WAS REPORTED THAT DURING ARTHROSCOPIC LIGAMENT REPAIR, WHEN THE MILAGRO SCREW WAS INSERTED, THE 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 WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25239669 ↗
• MalfunctionApr 30, 2026Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED ARTHROSCOPIC PROCEDURE THE MILAGRO INSCR SMALL SIZE 5X23 SCREW DEVICE BROKE. ALL 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 25046838 ↗
• MalfunctionApr 28, 2026Break

  IT WAS REPORTED THAT DURING LIGAMENT RECONSTRUCTION SURGERY, THE MILAGRO 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 HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25018434 ↗
• MalfunctionApr 22, 2026Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED ARTHROSCOPIC PROCEDURE THAT THE MILAGRO INSCR SMALL SIZE 5X23 SCREW DEVICE BROKE. 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 24957278 ↗
• MalfunctionApr 11, 2026Migration

  IT WAS REPORTED THAT DURING AN UNSPECIFIED ARTHROSCOPIC PROCEDURE THE MILAGRO INSCR SMALL SIZE 5X23 SCREW DEVICE PULLED OUT. 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 24848041 ↗
• MalfunctionMar 26, 2026Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED ARTHROSCOPIC PROCEDURE THAT THE MILAGRO INSCR SMALL SIZE 5X23 SCREW DEVICE BROKE. ALL THE BROKEN PIECES 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 24701851 ↗
• MalfunctionMar 20, 2026Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC LIGAMENT REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT THE MILAGRO INSCR SMALL DEVICE SCREW BROKE OFF. ALL THE BROKEN PARTS WERE REMOVED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO 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 24651670 ↗
• MalfunctionMar 11, 2026Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT WHILE USING THE MILAGRO INSCR SMALL DEVICE THE SCREW BROKE WHILE INSERTING IT. ALL BROKEN WERE REMOVED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. 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 24576214 ↗
• MalfunctionJan 12, 2026Break

  IT WAS REPORTED THAT DURING A KNEE JOINT LIGAMENT REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT THE MILAGRO INSCR SMALL SIZE 5X23 SCREW DEVICE WAS BROKEN. IT WAS REPORTED THAT ALL BROKEN PIECES WERE REMOVED AND 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 24032115 ↗
• MalfunctionDec 17, 2025Break; Break

  IT WAS REPORTED THAT DURING A LATERAL COLLATERAL LIGAMENT (LCL) SURGICAL PROCEDURE, WHILE ATTEMPTING TO INSERT A MILAGRO INSCR SMALL SIZE 6X23 SCREW DEVICE AND A MILAGRO INSCR SMALL SIZE 5X23 SCREW DEVICE, IT WAS OBSERVED THAT BOTH SCREWS SNAPPED AT THE PROXIMAL ENDS. IT WAS REPORTED THAT THE EVENT COULD HAVE BEEN AVOIDED IF THE CORRECT INSERTION DEVICE WAS PROVIDED. IT WAS REPORTED THAT NO DEBRIS WAS LEFT IN THE PATIENT AND THE SMALL FRAGMENTS WERE RETRIEVED. IT WAS REPORTED THAT ANOTHER DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. IT WAS REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT, OR SURGICAL DELAY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23832213 ↗
• MalfunctionOct 30, 2025Migration; Migration

  IT WAS REPORTED THAT DURING AN ANKLE JOINT SURGERY, IT WAS OBSERVED THAT THE MILAGRO INSCR SMALL SIZE 5X23 DEVICE ANCHOR WAS PULLED OUT. 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 23422905 ↗
• MalfunctionOct 28, 2025Break; Break

  IT WAS REPORTED THAT DURING A KNEE COLLATERAL LIGAMENT REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT THE MILAGRO INSCR SMALL DEVICE ANCHOR WAS BROKEN OFF. ALL BROKEN PARTS WERE REMOVED. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23407157 ↗
• MalfunctionOct 22, 2025Break; Break

  IT WAS REPORTED THAT DURING A TALOFIBULAR LIGAMENT REPAIR PROCEDURE, THE SCREW ON THE MILAGRO INSCR SMALL SIZE 5X23 DEVICE BROKE OFF WHEN INSERTED. ALL THE PIECES WERE REMOVED FROM THE PATIENT. 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 23358975 ↗
• MalfunctionOct 20, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SURGICAL PROCEDURE OF THE ANKLE IT WAS OBSERVED THAT THE MILAGRO INSCR SMALL SIZE 5X23 SCREW DEVICE WAS BROKEN. 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 23337806 ↗
• MalfunctionSep 18, 2025Break; Break

  IT WAS REPORTED THAT DURING A PATELLAR LIGAMENT RECONSTRUCTION PROCEDURE, IT WAS DISCOVERED THAT THE ANCHOR ON THE MILAGRO INSCR SMALL SIZE 5X23 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. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23088988 ↗
• MalfunctionSep 15, 2025Break; Break

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE FOR A PATELLAR DISLOCATION IT WAS OBSERVED THAT THE MILAGRO INSCR SMALL SIZE 5X23 ANCHOR DEVICE WAS BROKEN OFF. IT WAS THAT THERE WAS A 5-MINUTE DELAY IN THE PROCEDURE DUE TO THE EVENT. IT WAS REPORTED THAT ALL BROKEN PARTS OF THE DEVICE WERE REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23058568 ↗
• MalfunctionSep 12, 2025Break; Break

  IT WAS REPORTED THAT DURING A PATELLOFEMORAL LIGAMENT RECONSTRUCTION PROCEDURE, IT WAS DISCOVERED THAT THE ANCHOR ON THE MILAGRO INSCR SMALL SIZE 5X23 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. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23038500 ↗
• MalfunctionAug 25, 2025Break; Break

  IT WAS REPORTED THAT DURING A RECONSTRUCTION OF ANTERIOR CRUCIATE LIGAMENT SURGICAL PROCEDURE IT WAS OBSERVED THAT THE MILAGRO INSCR SMALL SIZE DEVICE ANCHOR WAS BROKEN OFF. ALL BROKEN PARTS WERE REMOVED. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22890063 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K103831, K150209. One submission often covers many models, so check the product and lot details in each record.

• Z-1680-2023 · Apr 13, 2023 · Open, Classified
  DePuy Mitek BIOKNOTLESS Rapid W/ OC-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212722
• Z-1678-2023 · Apr 13, 2023 · Open, Classified
  DePuy Mitek BIOKNOTLESS Plus w/ Panacryl-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212725
• Z-1679-2023 · Apr 13, 2023 · Open, Classified
  DePuy Mitek BIOKNOTLESS Plus w/ OC-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212726
• Z-1681-2023 · Apr 13, 2023 · Open, Classified
  DePuy Mitek BIOKNOTLESS Rapid w/ Pan-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212723
• Z-1677-2023 · Apr 13, 2023 · Open, Classified
  DePuy Mitek BIOKNOTLESS Plus w/ Ethibond-Iindicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212724