MILAGRO 231804Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10886705010721), received between Dec 5, 2018 and Apr 1, 2025 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Break” (12 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 1, 2025Break; Break

  IT WAS REPORTED THAT DURING A BICEPS TENDON REPAIR PROCEDURE, IT WAS DISCOVERED THAT THE ANCHOR ON THE MILAGRO INSCR SMALL SIZE 5X30 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 21740331 ↗
• MalfunctionMar 25, 2024Break; Break

  IT WAS REPORTED BY THE SALES REP IN HUNGARY THAT DURING A RECONSTRUCTION OF POSTERIOR CRUCIATE LIGAMENT INSERTION POINT SURGICAL PROCEDURE ON (B)(6) 2024 THE MILAGRO INSCR SMALL SIZE DEVICE ANCHOR WAS BROKEN OFF. 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 18974508 ↗
• MalfunctionNov 30, 2023Break; Break

  IT WAS REPORTED BY A DISTRIBUTOR IN SPAIN THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON 1/16/2023 THE MILAGRO INSCR SMALL SIZE 5X30 DEVICE SCREW BROKE WHEN BEING INSERTED INTO THE TIBIAL TUNNEL. THERE WAS NO DELAY TO THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18238813 ↗
• MalfunctionOct 20, 2023Break; Corroded; Fracture; Break; Corroded; Fracture

  IT WAS REPORTED BY THE SALES REP IN CHINA THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2023 THE MILAGRO INSCR SMALL SIZE 5X30 DEVICE ANCHOR 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 ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17979920 ↗
• MalfunctionMar 9, 2023Break; Break

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN CHINA THAT DURING AN UNKNOWN PROCEDURE ON 2/15/2023, IT WAS OBSERVED THAT THE 5MM X 30MM MILAGRO SCREW DEVICE BROKE OFF. 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 16513097 ↗
• MalfunctionFeb 6, 2023Break; Break

  MILAGRO INTERFERENCE SCREW 5X30 MM BROKE DURING SURGERY IN THE CLINIC. THE SCREW BROKE DURING TIGHTENING. A UNFORTUNATELY, THE BROKEN PIECE OF THE SCREW WAS THROWN OUT. THE PHOTO OF THE LABEL IN THE ATTACHMENT. THE PATIENT IS IN A SATISFACTORY CONDITION. LOCATION OF THE INCIDENT: (B)(6). IT WAS REPORTED BY THE AFFILIATE IN RUSSIA THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE 5MM X 30MM MILAGRO SCREW DEVICE BROKE DURING TIGHTENING. ACCORDING TO THE REPORT, APPROXIMATELY 2/3 OF THE SCREW WAS SCREWED AND REMAINED INTO THE BONE WHILE THE OTHER 1/3 OF THE SCREW BROKE OFF DURING THE FINAL STAGE OF THE OPERATION. IT WAS FURTHER REPORTED THAT SINCE THERE WAS NO OTHER SCREW OF THIS SIZE AND THE FIXATION WAS 2/3 OF THE SCREW, THEY DECIDED NOT TO UNSCREW THE SCREW 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 16308158 ↗
• MalfunctionDec 30, 2022Material Deformation; Material Deformation

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN CHINA THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE THREADS ON THE 5MM X 30MM MILAGRO SCREW WERE PEELED. 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 16080203 ↗
• MalfunctionMar 26, 2020Break; Break

  IT WAS REPORTED BY SALES REPRESENTATIVE VIA COMPLAINT SUBMISSION TOOL THAT DURING THE PROCEDURE THE MILAGRO INSCR SMALL SIZE 5 X 30 AFTER ATTEMPTING TO INSERT A 5 X 30 MILAGRO INTO HIS DRILL HOLE, THE DR. PULLED THE SCREW BACK OUT AND NOTICED THAT THE DISTAL TIP OF THE SCREW HAD BROKEN OFF. THE PIECE WAS RECOVERED AND A NEW MILAGRO SCREW WAS OPENED. THE SURGERY PROCEEDED WITHOUT ANY FURTHER DELAY OR PATIENT HARM. THE DEVICE IS NOT AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: Not Applicable

  MAUDE report 9883969 ↗
• MalfunctionMay 28, 2019Break; Break

  IT WAS REPORTED BY THE SALES REP VIA CST THAT DURING A MPFL REPAIR PROCEDURE THE FIRST 5 X 30 MM MILAGRO SCREW WAS BEING INSERTED INTO THE PATIENT'S BONE TUNNEL WHEN THE DISTAL TIP OF THE SCREW BROKE OFF. THE BREAKAGE OCCURRED AFTER THE SUCCESSFUL PURCHASE OF THE LUPINES AND PASSING OF THE GRAFT THROUGH THE BONE TUNNEL. A 5 X 23 MM MILAGRO SCREW WAS OPENED AND EXPERIENCED THE SAME PROBLEM. THE BROKEN TIPS OF THE IMPLANTS REMAINED IN THE PATIENT AS THE IMPLANTS ARE MADE FROM BR MATERIAL. THERE WAS A FIVE MINUTE SURGICAL DELAY TO OPEN THE NEW MILAGRO SCREW. IT IS UNKNOWN IF THE CASE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Foreign Body In Patient; Not Applicable

  MAUDE report 8647808 ↗
• MalfunctionMay 2, 2019Break; Break

  IT WAS REPORTED THAT DURING A MPFL PROCEDURE FOR KNEE SURGERY, THE FIRST 5X30MM MILAGRO SCREW WAS BEING INSERTED AND THE TIP OF THE IMPLANT BROKE OFF IN THE PATIENT. THE CASE WAS COMPLETED WITH ANOTHER LIKE-SCREW. FRAGMENTS WERE GENERATED, BUT THE TIP OF THE IMPLANT REMAINED IN THE PATIENT. PATIENT'S BONE QUALITY WAS REPORTED AS DECENT. SAME BONE HOLE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A THREE MINUTE DELAY TO OPEN THE NEW IMPLANT AND NO PATIENT CONSEQUENCE WAS REPORTED. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8575345 ↗
• MalfunctionApr 12, 2019Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED BY THE SALES REP VIA CST THAT DURING A MEDICAL PATELLAFEMORAL RECONSTRUCTION PROCEDURE, TWO MILAGRO INTERFERENCE SCREWS BROKE DURING INSERTION. THE SALES REP STATED THE DOCTOR WAS USING TWO LUPINES AND TWO MILAGRO INTERFERENCE SCREWS WITH AN ALLOGRAFT. AFTER SECURE FIXATION OF THE GRAFT TO THE PATELLA USING THE TWO LUPINES, THE SURGEON DRILLED THE FEMORAL TUNNEL AND PULLED THE GRAFT THROUGH. THE FIRST MILAGRO INTERFERENCE SCREW TIP BROKE OFF DURING INSERTION. THE SURGEON THEN ATTEMPTED TO USE A SECOND MILAGRO INTERFERENCE SCREW AND THIS IMPLANT ALSO BROKE WHILE INSERTING. DEEMING ENOUGH FIXATION WAS ACCOMPLISHED EVEN WITH THE BROKEN TIPS OF THE IMPLANTS REMAINING IN THE PATIENT, THE CASE WAS FINISHED AND THE FRAGMENTS WERE NOT REMOVED. THERE WAS A FIVE MINUTE DELAY TO THE CASE TO OPEN THE NEW IMPLANT.

  Patient problems: Not Applicable

  MAUDE report 8509957 ↗
• MalfunctionApr 12, 2019Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED BY THE SALES REP VIA CST THAT DURING A MEDICAL PATELLAFEMORAL RECONSTRUCTION PROCEDURE, TWO MILAGRO INTERFERENCE SCREWS BROKE DURING INSERTION. THE SALES REP STATED THE DOCTOR WAS USING TWO LUPINES AND TWO MILAGRO INTERFERENCE SCREWS WITH AN ALLOGRAFT. AFTER SECURE FIXATION OF THE GRAFT TO THE PATELLA USING THE TWO LUPINES, THE SURGEON DRILLED THE FEMORAL TUNNEL AND PULLED THE GRAFT THROUGH. THE FIRST MILAGRO INTERFERENCE SCREW TIP BROKE OFF DURING INSERTION. THE SURGEON THEN ATTEMPTED TO USE A SECOND MILAGRO INTERFERENCE SCREW AND THIS IMPLANT ALSO BROKE WHILE INSERTING. DEEMING ENOUGH FIXATION WAS ACCOMPLISHED EVEN WITH THE BROKEN TIPS OF THE IMPLANTS REMAINING IN THE PATIENT, THE CASE WAS FINISHED AND THE FRAGMENTS WERE NOT REMOVED. THERE WAS A FIVE MINUTE DELAY TO THE CASE TO OPEN THE NEW IMPLANT.

  Patient problems: Not Applicable

  MAUDE report 8509892 ↗
• MalfunctionDec 5, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A MEDIAL PATELLA FEMORAL LIGAMENT RECONSTRUCTION SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE 5X30MM MILAGRO SCREW DEVICE BROKE IN HALF. THE SALES REP STATED THEY WERE ATTEMPTING TO FIXATE THE GRAFT WHEN THE SCREW BROKE. THE SALES REP STATED THAT HALF OF THE SCREW WAS RECOVERED BY USING A DRIVER AND THE REMAINING HALF WAS LEFT IN THE BONE FOR FIXATION. THE CASE WAS COMPLETED WITH HALF OF THE SCREW WITH NO PATIENT HARM OR DELAY. THE REMOVED HALF OF THE SCREW WAS DISCARDED BY THE CUSTOMER. THE SALES REP REPORTED THAT ADDITIONAL SCREWS WERE USED BUT NO ADDITIONAL BONE HOLE HAD TO BE CREATED. 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 8133146 ↗

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-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-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-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