MILAGRO 231805Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886705010738), received between May 7, 2018 and Apr 30, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (5 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. 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 30, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE MILAGRO INTSCR 7X30MM *EA DEVICE ANCHOR WAS BROKEN OFF, REMOVED ALL BROKEN PARTS. 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 21933750 ↗
• MalfunctionDec 29, 2023Break; Break

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN CHINA THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE 7MM X 30MM BIOCRYL RAPIDE INTERFERENCE SCREW DEVICE ANCHOR WAS BROKEN OFF WHEN INSERTED THE ANCHOR. REMOVED ALL THE BROKEN PARTS. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18417689 ↗
• MalfunctionJul 11, 2023Break; Break

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN CHINA THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE 7MM X 30MM BIOCRYL RAPIDE INTERFERENCE SCREW DEVICE BROKE OFF INTO TWO PIECES. REMOVED ALL THE BROKEN PARTS. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17301916 ↗
• MalfunctionJul 31, 2018Break; Break

  IT WAS REPORTED BY THE AFFILIATE THAT THE SCREW BROKE OFF AT THE 2/3 JUNCTION PROXIMAL, 1/3 DISTAL INTO THE TIBIA. THE 3 BROKEN PIECE WERE REMOVED FROM THE PATIENT. NO CONSEQUENCE PATIENTS TO DATE. WAIT 3 MONTHS IF POSSIBLE FAILURE OF THE LIGAMENTOPLASTY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7735068 ↗
• MalfunctionMay 7, 2018Break; Break

  IT WAS REPORTED BY OUR AFFILIATE THAT THE PHYSICIAN REPORTED THAT SCREW WAS BROKEN. NO CONSEQUENCES FOR THE PATIENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7491891 ↗

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-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-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