MILAGRO 231810Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10886705010776), received between Jun 15, 2018 and Sep 29, 2026 — classified as 23 malfunctions.

The most frequently reported specific device problem is “Break” (15 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933379 ↗
• MalfunctionAug 19, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50322668 ↗
• MalfunctionJun 4, 2026Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED ARTHROSCOPIC PROCEDURE THE MILAGRO INTSCR 8X23MM SCREW DEVICE BROKE. ALL BROKEN PARTS 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25399921 ↗
• MalfunctionMay 12, 2026Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ANTERIOR CRUCIATE LIGAMENT REPAIR PROCEDURE THE MILAGRO INTSCR 8X23MM SCREW DEVICE IS UNABLE TO BE TIGHTENED. THE SCREW WAS 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25151467 ↗
• MalfunctionJul 26, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT THE MILAGRO INTSCR 8X23MM EA DEVICE ANCHOR WAS BROKEN. 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 22621399 ↗
• MalfunctionMay 29, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT REPAIR SURGERY, IT WAS OBSERVED THAT THE MILAGRO INTSCR 8X23MM DEVICE THREAD WAS INCOMPLETE. 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 22104224 ↗
• MalfunctionMay 28, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT REPAIR PROCEDURE, IT WAS DISCOVERED THAT THE ANCHOR ON THE MILAGRO INTSCR 8X23MM EA 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 22097129 ↗
• MalfunctionFeb 25, 2025Break; Break

  IT WAS REPORTED THAT DURING A CRUCIATE LIGAMENT RECONSTRUCTION SURGICAL PROCEDURE IT WAS OBSERVED THAT THE MILAGRO INTSCR 8X23MM ANCHOR WAS BROKEN OFF. IT WAS REPORTED THAT ALL THE 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 21459405 ↗
• MalfunctionJan 14, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE, IT WAS DISCOVERED THAT AS THE SURGEON BEGAN TO SCREW IN THE COMPOSITE SCREW OF THE MILAGRO INTSCR 8X23MM *EA DEVICE, THE SCREW SPLIT IN HALF AFTER A FEW TURNS BEFORE BEING FULLY INSERTED IN THE PATIENT'S FEMORAL TUNNEL. THE SURGEON REMOVED THE BROKEN PIECES AND SCREWED THE FRAGMENT THAT WAS CLOSEST TO THE PATIENT FURTHER IN. THERE WAS LESS THAN A FIVE-MINUTE DELAY TO THE SURGICAL PROCEDURE. IT WAS NOT REPORTED WHETHER A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT REPORTED. 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 21151440 ↗
• MalfunctionJan 13, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE, IT WAS OBSERVED THAT THE DEVICE BROKE OFF, THEN ALL THE BROKEN PARTS WERE REMOVED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS PATIENT INVOLVEMENT. 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 21138572 ↗
• MalfunctionSep 30, 2024Material Deformation; Material Deformation

  IT WAS REPORTED FROM CHINA THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE MILAGRO INTSCR 8X23MM DEVICE CUTTER APPEARED TO BE BENT AS THE SUTURE COULD NOT BE CUT WELL AND THE SUTURE WOULDN'T HOLD IN THE CUTTER. 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 20333127 ↗
• MalfunctionApr 25, 2024Break; Break

  IT WAS REPORTED FROM CHINA THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE MILAGRO INTSCR 8X23MM *EA DEVICE ANCHOR WAS BROKEN 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 19180195 ↗
• MalfunctionSep 10, 2021Difficult to Advance; Mechanical Jam; Difficult to Advance; Mechanical Jam

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE MILAGRO INTSCR 8X23MM DEVICE WAS NOT POSSIBLE TO SCREW INTO THE CANAL CORRECTLY; AND THAT IT COULD NOT BE REMOVED FROM THE SCREWDRIVER. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A DELAY OF FIVE MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12453080 ↗
• MalfunctionFeb 18, 2021Break; Break

  IT WAS REPORTED BY THE CUSTOMER IN CHINA THAT DURING A POSTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE MILAGRO INTSCR 8X23MM EA DEVICE BROKE. ALL THE FRAGMENTS WERE REMOVED. ANOTHER LIKE 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 11345014 ↗
• MalfunctionOct 24, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, DURING RECONSTRUCTION OF THE LEFT KNEE ANTERIOR CRUCIATE AFTER THE FIXATION, THE ANCHOR WAS SCREWED INTO THE TENDON THAT WAS EXPOSED AT THE TIBIA. THE MILAGRO INTSCR 8X23MM *EA WAS BROKEN OFF FROM THE MIDDLE AND THE BROKEN PIECES WERE REMOVED FROM THE PATIENT. A NEW MILAGRO INTSCR 8X23MM *EA HAD TO BE USED TO COMPLETE THE SURGERY. NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) MILAGRO INTSCR 8X23MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9234712 ↗
• MalfunctionAug 2, 2019Break; Break

  UPDATED: DATE OF SURGERY WAS REPORTED AS JULY 5, 2019. THE SURGERY WAS COMPLETED WITH ANOTHER SCREW OF THE SAME DIAMETER. THE LARGE FRAGMENT WAS REMOVED FROM THE PATIENT HOWEVER, THERE WAS SOME RESIDUE LEFT BEHIND. SURGICAL DELAY OF 30 MINUTES WAS NOTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8857415 ↗
• MalfunctionMay 6, 2019Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, IT WAS OBSERVED THAT THE TIP OF THE 8X23MM MILAGRO SCREW WAS SMASHED SO THAT THE SURGEON COULD NOT INSERT THE SCREW INTO THE PATIENT'S BODY. THE SURGERY WAS FINISHED WITHOUT ANY OTHER PROBLEM, ALTHOUGH IT WAS NOT REPORTED HOW THE SURGERY WAS COMPLETED. IT WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8581858 ↗
• MalfunctionFeb 15, 2019Crack; Crack

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN ACL RECONSTRUCTION PROCEDURE THE SALES REP'S 8X23MM MILAGRO INTERFERENCE SCREW CRACKED WHILE INSERTING INTO THE PATIENT. THE SALES REP STATED THAT THERE WAS A LINEAR CRACK ON THE FACE OF THE SCREW. THE SCREW WAS BACKED OUT OF THE PATIENT WITH A DRIVER WITH NO DEBRIS LEFT BEHIND. THE SALES REP STATED THAT THE PATIENT HAD HARD BONE QUALITY. THE CASE WAS COMPLETED WITH ANOTHER LIKE-IMPLANT WITH NO PATIENT HARM OR DELAY. THERE IS NO NEED FOR SURGICAL INTERVENTION. THE DEVICE WAS DISCARDED BY THE CUSTOMER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8345097 ↗
• MalfunctionDec 26, 2018Migration or Expulsion of Device; Deformation Due to Compressive Stress; Material Twisted/Bent; Migration or Expulsion of Device; Deformation Due to Compressive Stress; Material Twisted/Bent

  ADDITIONAL INFORMATION RECEIVED FROM THE AFFILIATE ON 01/11/2019 STATING THE EVENT OCCURRED ON (B)(6)2018 AND THE ADVERSE EVENT WAS DESCRIBED AS THE ACL PULLOUT FROM FEMUR OR TIBIAL. IT WAS REPORTED THAT THE CASE WAS COMPLETED OPENING OTHER STOCKS. ADDITIONAL INFORMATION RECEIVED FROM THE AFFILIATE ON 01/15/2019 STATING THAT THE EVENT OCCURRED INTRA-OP AND THERE WAS A SURGICAL DELAY OF 15 MINUTES DUE TO THE EVENT. THERE WAS NO PATIENT HARM DUE TO THE SURGICAL DELAY. THE CASE WAS COMPLETED WITH ANOTHER IMPLANT AND THERE ALL PIECES OF THE BROKEN IMPLANT WERE REMOVED. THE SURGEON WAS NOT OFF AXIS WHILE USING THE IMPLANT AND THE SAME BONE HOLE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient; Tissue Damage

  MAUDE report 8196542 ↗
• MalfunctionNov 26, 2018Break; Break

  IT WAS REPORTED THAT DURING AN ACL RECON, A MILAGRO WAS SCREWED INTO TO BONE. DURING SCREWING, THE SURGEON FELT THAT EVERYTHING WAS FINE BUT IN THE END THE SCREWDRIVER DIDN´T WORK ANYMORE. WHEN HE PULLED OUT THE SCREW, IT WAS NOTED TO BE PARTIALLY BROKEN. THE LARGER PART STAYED IN A BONE AND EVERYTHING WAS FINE AND FIXED. THE OPERATION WAS FINISHED AND NOTHING WAS DAMAGED. NO DELAY IN PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8102871 ↗
• MalfunctionAug 6, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) REPAIR, IT WAS OBSERVED THAT MILAGRO INTERFACE SCREW, 8 X 23MM BROKE WHEN IT WAS HALF WAY INSERTED INTO THE BONE TUNNEL. THE SURGEON LEFT THE TOP HALF SECURELY IN THE BONE AND REMOVED THE BROKEN PIECE. THE SURGOEN COMPLETED THE PROCEDURE BY PLACING ANOTHER MILAGRO INTERFACE SCREW, 8X 23MM ON TOP OF THE BROKEN ONE WITH NO PATIENT CONSEQUENCES OR DELAYS. THE SALES REP REPORTED THAT THE BONE HOLE WAS PREPPED WITH A REAMER. HE REPORTED THAT THE PATIENT WAS A YOUNG FEMALE WITH STANDARD BONE QUALITY. 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 7753832 ↗
• MalfunctionAug 2, 2018Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING ACL (ANTERIOR CRUCIATE LIGAMENT) REPAIR, IT WAS OBSERVED THAT THE MILAGRO INTERFERENCE SCREW, 8 X 23MM BROKE. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED WITH SAME LIKE PRODUCT. IT WAS NOT REPORTED IF THERE WERE ANY 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 7742836 ↗
• MalfunctionJun 15, 2018Break; Break

  AT TIBIAL BTB FIXATION THE MILAGRO SCREW BROKE WITHOUT USING ADDITIONAL FORCE. ADDITIONAL INFORMATION WAS RECEIVED FROM OUR AFFILIATE ON APRIL 24, 2013. THE SCREW BROKE IN THE MIDDLE DURING INSERTION INTO THE PATIENT. THE SURGEON DID NOT NOTCH PRIOR TO INSERTION, AND DID NOT INSERT THE SCREW OFF AXIS. THE SURGEON REMOVED THE BROKEN PIECE OF THE SCREW AND WAS SATISFIED WITH THE FIXATION OF THE DISTAL PORTION WHICH REMAINED IN THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7605245 ↗

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-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-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