MILAGRO 231835Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886705010820), received between Jan 3, 2018 and Feb 24, 2020 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 24, 2020Break; Break

  IT WAS REPORTED BY AFFILIATE VIA COMPLAINT SUBMISSION TOOL, THAT DURING AN UNKNOWN PROCEDURE, THE TIP OF A 10X23MM MILAGRO INTERFERENCE SCREW, BROKE OFF UPON INSERTION. NO SURGICAL DELAY OR PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9748060 ↗
• InjuryJul 31, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE AFFILIATE VIA (B)(4) THAT THE 3 MILAGRO SCREWS HAVE BEEN REMOVED DUE TO PATIENTS KNEE INFECTION. REMOVAL OF OSTEOSYNTHESIS MATERIAL.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8846647 ↗
• MalfunctionJan 14, 2019Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE CUSTOMER'S MILAGRO INTERFERENCE SCREW, 10 X 23MM BROKE UPON INSERTION. THE SALES REP REPORTED THAT THE SURGEON WAS USING TOO MUCH FORCE AT THE TIME. THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER LIKE SCREW IN THE SAME BONE HOLE WITH NO PATIENT CONSEQUENCES OR DELAYS. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8245156 ↗
• InjuryAug 17, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP REPORTED THAT DURING AN ACL PROCEDURE THE CUSTOMER'S MILAGRO INTERFERENCE SCREW 10X23MM BROKE IN HALF DURING INSERTION IN THE PATIENT. THE SALES REP STATED THAT THE SURGEON BACKED OUT THE SCREW AND REMOVED THE BROKEN PIECES WITHOUT ANY ISSUES. THE SALES REP STATED THAT THERE WAS NO DEBRIS LEFT IN THE PATIENT. THE SALES REP REPORTED THAT THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER LIKE DEVICE USING THE SAME BONE HOLE WITH NO PATIENT CONSEQUENCES BUT THERE WAS A FIVE MINUTE DELAY. THE SALES REP STATED THAT THE PATIENT HAS A SOFT BONE QUALITY. HE ALSO STATED THAT DUE TO THE PATIENT BONE QUALITY THAT HE FOUND IT OUT OF THE ORDINARY FOR THE DEVICE TO BREAK LIKE IT DID. THE SALES REP STATED THAT THE DEVICE WAS DISCARDED. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7794728 ↗
• InjuryJan 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WHO WAS INITIALLY OPERATED ON (B)(6) 2016 FOR LCA RECONSTRUCTION, WAS SCHEDULED FOR REMOVAL THE TIBIAL FIXATION MATERIAL DUE TO TIBIAL TUNNEL CYST FORMATION. IN THIS SECOND SURGERY, THERE WAS NOTED AN INFLAMMATION IN THE SKIN, WHEN THE CYST IS FOUND WITH YELLOW AQUEOUS MATERIAL, THE CYST POCKET IS RESECTED AND AT THE ENTRANCE OF THE TUNNEL, WHITISH CREAM-LIKE MATERIAL IS OBSERVED. THIS MATERIAL WAS EXTRACTED WITH A CURETTE AND THE SITE IS WASHED THOROUGHLY. WHEN THE MATERIAL IS REMOVED, THERE IS A DEFECT IN THE TUNNEL. THE STABILITY OF THE GRAFT IS VERIFIED AND IT IS IN OPTIMAL CONDITIONS. PATIENT WITHOUT ANY ALTERATION OR RISK SO FAR. ATTACHED IMAGES OF THE CASE. PATIENT CONSEQUENCE? :YES PATIENT CONSEQUENCE DESCRIPTION: PATIENT PRESENTED INFLAMMATORY REACTION AFTER IMPLANTATION OF SCREW MIRACLE AND REQUIRED REOPERATION TO REMOVE THE MATERIAL.. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? : YES. COMPLAINT IS BEING REGISTERED LATE, SINCE THE J&J ALERT DATE IS (B)(6) 2017 AND THE SALES REP SENT IT TO US ON (B)(6) 2017.

  Patient problems: Abscess; Foreign Body Reaction

  MAUDE report 7161942 ↗

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-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
• 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