MILAGRO 231820Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10886705010790), received between Apr 15, 2019 and May 11, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (6 reports).

5 other recalls cover devices cleared under the same FDA submission (K032717, K060830, 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 11, 2026Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ANTERIOR CRUCIATE LIGAMENT REPAIR PROCEDURE THE MILAGRO INTSCR 9X23MM ANCHOR DEVICE BROKE. ALL 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. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25142462 ↗
• MalfunctionMar 19, 2025Break; Break

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE MILAGRO INTSCR 9X23MM ANCHOR DEVICE WAS BROKEN OFF. IT WAS REPORTED THAT ALL BROKEN PARTS WERE 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 21646902 ↗
• MalfunctionMay 3, 2024Break; Break

  IT WAS REPORTED FROM CHINA BY THE SALES REP THAT DURING A ANTERIOR CRUCIATE LIGAMENT (ACL) SURGICAL PROCEDURE ON (B)(6) 2024. THE MILAGRO INTSCR DEVICE SCREW WAS BROKEN. WHEN INSERTING THE SCREW, THE SCREW WAS BROKEN. ALL THE PIECES WERE REMOVED FROM THE PATIENT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19239314 ↗
• MalfunctionNov 21, 2023Break; Break

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN CHINA THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE MILAGRO INTSCR 9X23MM 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 18185226 ↗
• MalfunctionAug 15, 2023Material Deformation; Material Deformation

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN CHINA THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE THREADS ON THE MILAGRO INTERFERENCE SCREW 9 X 23MM DEVICE WERE PEELED; AND THAT THE INSIDE OF THE SCREW WAS SLIPPERY WHEN SCREWING IT IN. 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 17550816 ↗
• MalfunctionNov 23, 2021Difficult to Advance; Difficult to Advance

  IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT THE MILAGRO INTSCR 9X23MM ANCHOR DEVICE COULD NOT BE SECURED IN THE BONE HOLE. 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 12863244 ↗
• MalfunctionOct 29, 2020Dull, Blunt; Material Twisted/Bent; Dull, Blunt; Material Twisted/Bent

  IT WAS REPORTED BY J&J EMPLOYEE VIA EMAIL, THAT DURING AN LCA, WHILE USING A MILAGRO INTERFERENCE SCREW 9X23 MM, THIS GOT STUCK ON THE SCREWDRIVER. PROCEDURE WAS COMPLETED BY USING A SAME LIKE PRODUCT. THERE WAS A SURGICAL DELAY OF 2 MINUTES, AND NO PATIENT CONSEQUENCES.

  Patient problems: Not Applicable

  MAUDE report 10759809 ↗
• MalfunctionDec 3, 2019Break; Break

  IT WAS REPORTED VIA COMPLAINT SUBMISSION TOOL; CST, BY THE AFFILIATE THAT DURING AN ACL SURGERY , THE SURGEON WAS TRYING TO PLACE THE SCREW IN PLACE IT BROKE. THE AFFILIATE REPORTED A SURGICAL DELAY DID NOT OCCUR BUT COULD NOT PROVIDE ADDITIONAL DETAILS. NO PATIENT OR USER CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9403645 ↗
• MalfunctionApr 15, 2019Break; Break

  IT WAS REPORTED THAT DURING A RECONSTRUCTION OF THE ANTERIOR CRUCIATE LIGAMENT, AT THE END OF INTRODUCING A MIRAGRO SCREW TO HOLD A BONE-TENDON-BONE GRAFT, THE SCREW WAS BROKEN INTO SEVERAL PIECES. SOME OF THE FRAGMENTS WERE ABLE TO BE REMOVED, BUT THE TIP OF THE SCREW WAS LEFT INSIDE THE FEMORAL TUNNEL AND HOLDING THE GRAFT. THE FRAGMENTS OF THE SCREW THAT REMAINED INTRA-ARTICULAR AFTER THE RUPTURE OF THE IMPLANT COULD BE REMOVED AND ONLY ONE OF THE FRAGMENTS REMAINED INSIDE THE TUNNEL, FIXING THE GRAFT AND COULD NOT EXTRACT. THE SURGEON PERFORMED A STABILITY TEST OF THE LIGAMENT WITH THE FRAGMENT THAT REMAINED INSIDE THE FEMORAL TUNNEL AND DECIDED NOT TO INCLUDE ANOTHER MEANS OF FIXATION SINCE THE GRAFT WAS FIXED WITH THE FRAGMENT OF THE SCREW THAT REMAINED IMPLANTED. THE PROCEDURE WAS DELAYED BY 15 MINUTES BUT SUCCESSFULLY COMPLETED. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8514616 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K032717, K060830, 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-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-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-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