MILAGRO 231807Recalls & reported problems

Summary

The FDA's MAUDE database contains 98 adverse event reports that list this exact device (DI 10886705010752), received between Dec 14, 2017 and Sep 29, 2026 — classified as 2 injuries, 96 malfunctions.

The most frequently reported specific device problem is “Break” (84 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 98 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Difficult to Advance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50938195 ↗
• MalfunctionAug 26, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50457382 ↗
• MalfunctionJun 24, 2026Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY SURGERY, WHEN THE MILAGRO SCREW WAS INSERTED, THE 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 WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25605589 ↗
• MalfunctionJun 18, 2026Delivered as Unsterile Product

  IT WAS REPORTED THAT THE MILAGRO INSCR SMALL-SIZE 6X23 DEVICE WAS FOUND TO BE UNSTERILIZED. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. 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 25547299 ↗
• MalfunctionApr 28, 2026Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE 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 COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25014257 ↗
• MalfunctionApr 23, 2026Break

  IT WAS REPORTED THAT DURING KNEE ARTHROSCOPY MEDIAL COLLATERAL LIGAMENT REPAIR SURGERY, WHEN INSERTING THE MILAGRO SCREW DEVICE, THE 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 24971103 ↗
• MalfunctionApr 8, 2026Difficult to Advance

  IT WAS REPORTED THAT DURING INSERTION OF THE 6X23MM MILAGRO SCREW FOR MEDIAL PATELLA FEMORAL LIGAMENT RECONSTRUCTION SURGICAL PROCEDURE, THE SCREW WOULD NOT ENGAGE DURING THE PROCESS. EFFORTS WERE MADE TO INSERT THE SCREW THREE SEPARATE TIMES, EACH TIME WITHOUT SUCCESS. FOLLOWING THESE UNSUCCESSFUL ATTEMPTS, AN ALTERNATIVE SCREW WAS OPENED FOR USE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED, AND NO FRAGMENTS WERE GENERATED. A 4-MINUTE SURGICAL DELAY WAS NOTED AND THERE WAS NO HARM TO THE PATIENT. THE DEVICE IS NOT AVAILABLE FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24821067 ↗
• MalfunctionMar 26, 2026Break

  IT WAS REPORTED THAT DURING ARTHROSCOPIC LIGAMENT REPAIR SURGERY SURGERY, WHEN INSERTING THE MILAGRO SCREW DEVICE, THE 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 24700106 ↗
• MalfunctionMar 24, 2026Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED ARTHROSCOPIC PROCEDURE THAT THE MILAGRO INSCR SMALL SIZE 6X23 SCREW ANCHOR DEVICE BROKE DURING INSERTION. 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 24682748 ↗
• MalfunctionMar 20, 2026Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC LIGAMENT REPAIR PROCEDURE; IT WAS DISCOVERED THAT THE SCREW ON THE MILAGRO INSCR SMALL SIZE 6X23 DEVICE BROKE. ALL THE BROKEN PARTS WERE REMOVED FROM THE PATIENT. THERE WERE NO DELAYS IN 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 24652238 ↗
• MalfunctionMar 19, 2026Break

  IT WAS REPORTED THAT DURING AN ARTHROPLASTY SURGERY THE SCREW ON THE MILAGRO INSCR SMALL SIZE 6 X 23 DEVICE BROKE DURING INSERTION. ALL BROKEN 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 24637583 ↗
• MalfunctionMar 17, 2026Break

  IT WAS REPORTED THAT DURING A SPORTS MEDICINE ARTHROSCOPY SURGICAL PROCEDURE IT WAS OBSERVED THAT THE MILAGRO INSCR SMALL DEVICE SCREW BROKE OFF. ALL BROKEN PARTS 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 24618762 ↗
• MalfunctionFeb 4, 2026Break

  THIS IS EVENT 2 OF 4 OF (B)(4). IT WAS REPORTED THAT DURING A JOINT SURGICAL PROCEDURE IT WAS OBSERVED THAT 2X MILAGRO ADVANCE SCREW DEVICES AND 2X RIGIDFIX FEM 3.3MM S/T XPIN DEVICES BROKE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. 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 24261077 ↗
• 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 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23832111 ↗
• MalfunctionDec 16, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR BONE GRAFT RECONSTRUCTION SURGICAL PROCEDURE, WHEN INSERTING THE MILAGRO INSCR SMALL SIZE 6X23 SCREW DEVICE, IT WAS OBSERVED THAT THE SCREW WAS BROKEN. IT WAS REPORTED THAT 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 23822434 ↗
• MalfunctionDec 16, 2025Break; Break

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY SURGERY, WHEN INSERTING THE MILAGRO INSCR SMALL SIZE 6X23 SCREW, IT WAS OBSERVED THAT THE SCREW WAS BROKEN. IT WAS REPORTED THAT 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 23819115 ↗
• MalfunctionDec 4, 2025Break; Break

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT REPAIR PROCEDURE, IT WAS DISCOVERED THAT AFTER FIRST FIRING, TWO PLATES FROM THE TRUESPAN 24 DEGREE PEEK DEVICE WERE DEPLOYED SIMULTANEOUSLY. IT WAS FURTHER REPORTED THAT WHEN THE SCREW FROM THE MILAGRO INSCR SMALL SIZE 6X23 DEVICE WAS INSERTED, IT BROKE OFF. 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 SPARE DEVICES WERE 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 23720888 ↗
• MalfunctionDec 4, 2025Break; Break

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY PROCEDURE, IT WAS DISCOVERED THAT THE SCREW ON THE MILAGRO INSCR SMALL SIZE 6X23 DEVICE BROKE OFF. ALL THE BROKEN PARTS 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 23720559 ↗
• MalfunctionNov 4, 2025Break; Break

  THIS IS REPORT 2 OF 3 OF THE SAME EVENT IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) SURGICAL PROCEDURE IT WAS OBSERVED THAT THE RGDLOOP ADJUSTABLE STND DEVICE SUTURE WAS BROKEN OFF WHEN TIGHTENED. THE USER CHANGED TO ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. THE USER THEN CHANGED THE ANCHOR TO CONTINUE THE SURGERY, THE ANCHOR WAS BROKEN OFF. REMOVED ALL THE BROKEN PARTS. 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 23468274 ↗
• MalfunctionOct 21, 2025Break; Break

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY SURGICAL PROCEDURE IT WAS OBSERVED THAT THE MILAGRO INSCR SMALL SIZE 6X23 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 23346775 ↗
• MalfunctionSep 19, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) 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 23100675 ↗
• MalfunctionSep 19, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) 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 23095510 ↗
• MalfunctionSep 15, 2025Break; Break

  REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT REPAIR SURGERY, IT WAS OBSERVED THAT THE RGDLOOP ADJUSTABLE STND DEVICE SUTURE WAS BROKEN OFF WHEN THE SUTURE WAS TIGHTENED AND THE MILAGRO INSCR SMALL SIZE 6X23 DEVICE WAS BROKEN WHEN IT WAS INSERTED. IT WAS REPORTED THAT ALL 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 23050096 ↗
• MalfunctionSep 9, 2025Product Quality Problem; Difficult to Advance; Product Quality Problem; Difficult to Advance

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) RECONSTRUCTION SURGICAL PROCEDURE, IT WAS OBSERVED THAT WHEN THE SURGEON ATTEMPTED TO INSERT A MILAGRO INSCR SMALL SIZE 6X23 SCREW FOR LATERAL TENODESIS, HE REALIZED THAT THE SCREW WAS NOT CANNULATED, MAKING INSERTION IMPOSSIBLE. IT WAS REPORTED THAT ANOTHER DEVICE WAS USED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. IT WAS REPORTED THAT THERE WAS A 5-MINUTE DELAY IN THE PROCEDURE DUE TO THE EVENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23006116 ↗
• MalfunctionAug 5, 2025Break; Break

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE FOR RECONSTRUCTION OF PATELLAR THE LIGAMENT IN THE KNEE, IT WAS OBSERVED THAT THE MILAGRO INSCR DEVICE ANCHOR BROKE OFF. THE USER CHANGED TO ANOTHER ONE TO CONTINUE THE SURGERY, HOWEVER THE SAME PROBLEM HAPPENED AGAIN. 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. THIS IS REPORT 2 OF 2 OF (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22719693 ↗

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-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
• 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-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-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-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