MILAGRO 231809Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10886705010769), received between Jul 25, 2018 and May 13, 2026 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 18, 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 13, 2026Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, WHEN USING THE GRYPHON ORTHOCORD, THE ANCHOR BROKE OFF. ALL THE BROKEN PARTS WERE REMOVED. CHANGED ANOTHER THE SAME PRODUCT CODE OF THE GRYPHON ORTHOCORD ANCHOR TO CONTINUE THE SURGERY. AFTERWARDS, WHEN THE MILAGRO SCREW WAS INSERTED, THE SCREW BROKE. ALL THE PIECES WERE REMOVED FROM THE PATIENT. ANOTHER THE SAME PRODUCT CODE OF THE MILAGRO SCREW WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25162688 ↗
• MalfunctionAug 1, 2025Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT THE MILAGRO INSCR SMALL SIZE 6X30 SCREW DEVICE SCREW SLIPPED OFF AND COULD NOT BE INSERTED. 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 22689958 ↗
• MalfunctionJan 3, 2025Break; Break

  IT WAS REPORTED THAT DURING A TENDON REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT THE MILAGRO INSCR SMALL SIZE 6X30 ANCHOR DEVICE BROKE OFF. IT WAS REPORTED THAT ALL BROKEN PARTS WERE REMOVED. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21072630 ↗
• MalfunctionAug 9, 2023Break; Break

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN CHINA THAT DURING A PATELLAR LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE 6MM X 30MM MILAGRO SCREW 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 17490634 ↗
• MalfunctionAug 3, 2021Break; Break

  IT WAS REPORTED BY THE CUSTOMER IN (B)(4) THAT DURING AN ARTHROSCOPIC PATELLAR EXPLORATION + INCISION ANCHOR RECONSTRUCTION PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE MILAGRO INSCR SMALL SIZE 6X30 DEVICE BROKE. ALL BROKEN PARTS WERE REMOVED. 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 12269374 ↗
• InjuryMar 27, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED BY AFFILIATE VIA COMPLAINT SUBMISSION TOOL THAT A MONTH AFTER PROCEDURE THE MILAGRO INSCR SMALL SIZE 6X30 SCREW MOVED UPWARDS INTO THE JOINT SPACE, AS A CONSEQUENCE THE PATIENT HAD STRANGE FEELING IN THE POPLITEUS, A SURGERY WAS PERFORMED AND THE SURGEON WAS NOT ABLE TO REMOVE THE SCREW. THE DEVICE IS NOT AVAILABLE TO BE RETURNED FOR EVALUATION. ADDITIONAL INFORMATION PROVIDED BY THE AFFILIATE REPORTED THE SURGEON REPORTED THE PATIENT FEELS SOMETHING DISTURBING TO HIM NEAR HIS POPLITEUS. IT WAS REPORTED AN X-RAY IS SCHEDULED TO OCCUR SOME TIME SOON BUT THE EXACT TIME IS UNKNOWN. THE AFFILIATE REPORTED IT WAS UNKNOWN IF THE SCREW HAS CAUSED ANY ADDITION HARM OR WHAT THE PATIENT'S PROGNOSIS MAYBE. IT WAS ALSO REPORTED THE LOT NUMBER IS UNKNOWN.

  Patient problems: No Code Available; Tissue Damage

  MAUDE report 9890985 ↗
• MalfunctionFeb 7, 2019Break; Break

  PHYSICIAN REPORTED THAT SCREW IS BROKEN. NO ADDITIONAL DETAILS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8317418 ↗
• MalfunctionJan 30, 2019Fracture; Fracture

  IT WAS REPORTED THAT DURING MPFL RECONSTRUCTION THE SURGEON USED THE DEVICE FOR GRAFT FIXATION OF THE FEMUR. IT WAS REPORTED THAT THE TIP OF THE DEVICE BROKE WHEN HE INSERTED THE DEVICE IN A 6MM BONE HOLE AFTER PASSING A GRAFT THROUGH THE BONE HOLE AND INSERTING A GUIDE PIN. HE STOPPED USING THE DEVICE AND SUCCESSFULLY INSERTED A SHORTER SIZE OF THE DEVICE (6X23MM). IT WAS ALSO REPORTED THAT NO BROKEN PIECE WAS LEFT IN THE PATIENT¿S BODY. THERE WAS NO SURGICAL DELAY OR HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8288434 ↗
• MalfunctionJul 25, 2018Break; Break

  IT WAS REPORTED THAT THE SCREWS IN QUESTION WERE USED FOR OUTSIDE-IN ACL RECONSTRUCTION USING BTB GRAFT. DURING INSERTION OF MILAGRO BR 6 X 30 MM INTO THE FEMORAL SIDE, IT COULD NOT BE INSERTED FURTHER IN THE MIDDLE OF THE BONE HOLE. WHEN THE SURGEON REVERSED AND TRIED PULLED IT OUT, THE TIP OF THE SCREW (3-5 MM) WAS BROKEN AND THE BROKEN PIECE GOT STUCK BETWEEN THE BONE HOLE AND THE GRAFT. THE SURGEON REMOVED THE BROKEN PIECE USING AN OSTEOTOME AND RASPATORY, AND FIXED THE GRAFT WITH THE COMPETITOR¿S SCREW (6 X 30 MM) INSTEAD. FOR THE TIBIAL SIDE, MILAGRO ADVANCE 8 X 23 MM WAS USED, HOWEVER, THE DESIRED TENSION WAS NOT OBTAINED BY THE SCREW. THE SURGEON REMOVED THE SCREW AND RE-FIXED WITH THE COMPETITOR¿S DSP. THE PROCEDURE WAS COMPLETED WITHOUT ANY SURGICAL DELAY OR HARM TO THE PATIENT BECAUSE OF THESE PROBLEMS. THE BACKUP DEVICE WAS USED TO COMPLETE THE CASE. PLEASE SEE ALSO MEDWATCH REPORT 1221934-2018-52390.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7720195 ↗

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-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-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