MILAGRO 231815Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10886705010783), received between Jul 3, 2018 and Nov 12, 2023 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 12, 2023Break; Break

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN CHINA THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE MILAGRO INTERFERENCE SCREW ABSORBABLE 8 X 30MM 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 18117334 ↗
• MalfunctionSep 16, 2021Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A POSTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE MILAGRO INTSCR 8X30MM DEVICE WAS BROKEN OFF. ALL THE BROKEN PARTS WERE REMOVED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE SURGERY. 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 12482931 ↗
• MalfunctionJul 24, 2020Break; Break

  THIS IS REPORT 1 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP IN (B)(6) THAT DURING AN ORTHOPEDIC PROCEDURE, TWO MILAGRO INTERFERENCE SCREW ABSORBABLE 8 X 30MM DEVICES BROKE. NO SURGICAL DELAY OR PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10319435 ↗
• MalfunctionJul 24, 2020Break; Break

  THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP IN (B)(6) THAT DURING AN ORTHOPEDIC PROCEDURE, TWO MILAGRO INTERFERENCE SCREW ABSORBABLE 8 X 30MM DEVICES BROKE. NO SURGICAL DELAY OR PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10319434 ↗
• MalfunctionDec 26, 2018Deformation Due to Compressive Stress; Material Twisted/Bent; Deformation Due to Compressive Stress; Material Twisted/Bent

  ADDITIONAL INFORMATION RECEIVED FROM AFFILIATE STATING THAT THE EVENT OCCURRED INTRA-OPERATIVE. THERE WAS A DELAY OF 10 MINUTES. THERE WAS NO PATIENT IMPACT DUE TO THE DELAY. THE SAME BONE HOLE WAS USED TO COMPLETE THE PROCEDURE. A DIFFERENT READILY AVAILABLE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE DEVICE WILL BE RETURNING FOR EVALUATION.

  Patient problems: Injury; No Consequences Or Impact To Patient; Not Applicable

  MAUDE report 8196583 ↗
• MalfunctionAug 23, 2018Break; Break

  IT WAS REPORTED THAT DURING AN IMPLANT OF THE DEVICE, ONE (1) MILAGRO INTERFERENCE SCREW BROKE OFF. THERE WERE NO PATIENT ADVERSE CONSEQUENCES REPORTED. THERE IS NO FURTHER INFORMATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7810502 ↗
• MalfunctionAug 1, 2018Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING ANTERIOR CRUCIATE LIGAMENT TIBIAL FIXATION, THE MILAGRO SCREW HEAD BROKE WHILE TIGHTENING THEN THE SCREW CRACKED. IT WAS REPORTED THAT A SPARE SCREW DEVICE WAS USED TO COMPLETE THE PROCEDURE. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE. 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 7738843 ↗
• MalfunctionJul 23, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A BTB ACL REPAIR THAT THE CUSTOMER'S MILAGRO INTERFACE SCREW, 8 X 30MM CRUMBLED WHEN THE SURGEON ATTEMPTED TO INSERT IT INTO THE PATIENT'S JOINT SPACE. THE SURGEON FULLY REMOVED THE BROKEN PIECES AND USED ANOTHER SAME TYPE, SAME SIZE SCREW IN THE SAME BONE HOLE TO COMPLETE THE PROCEDURE. THE SALES REP CONFIRMED THERE WERE NO PATIENT CONSEQUENCES OR TIME DELAY. THE SALES REP COULD NOT PROVIDE THE LOT NUMBER. THE CUSTOMER ALREADY DISCARDED THE COMPLAINT DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7711304 ↗
• MalfunctionJul 18, 2018Break; Break

  OUR AFFILIATE REPORTED THE SCREW WAS BROKEN DURING INSERTION WHILE SCREWING IN THE BONE DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7699923 ↗
• MalfunctionJul 10, 2018Break; Break

  IT WAS REPORTED BY OUR AFFILIATE THAT A SCREW BROKE WHILE BEING INSERTED. IT WAS NOTED THAT THE SCREW BROKE DURING THE FIRST MOVEMENT WITHOUT PRESSURE. THE PROCEDURE WAS COMPLETED USING A LIKE PRODUCT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7673573 ↗
• MalfunctionJul 3, 2018Crack; Crack

  THE SALES REP REPORTED THAT DURING AN ACL PROCEDURE, THE CUSTOMER'S BIOINTRAFIX LARGE SHEATH WAS CRUSHED WHEN TAKEN OUT OF THE PACKAGE. THE PACKAGING WAS NOT DAMAGED. THE SURGEON THEN WENT TO INSERT THEIR 8X30MM MILAGRO INTERFERENCE SCREW AND UPON INSERTION IT BROKE INTO PIECES. THE SURGEON REMOVED ALL BROKEN FRAGMENTS OF THE ANCHOR AND WENT TO INSERT THEIR BIOINTRAFIX TAPERED SCREW AND IT ALSO BROKE INTO PIECES. THE SURGEON REMOVED ALL BROKEN FRAGMENTS OF THE SECOND ANCHOR AND USED A COMPETITOR'S ANCHOR TO COMPLETE THE PROCEDURE. THE SALES REP STATED THE PROCEDURE WAS DELAYED 20 MINUTES DUE TO THIS AND ALL COMPLAINT DEVICES WERE DISCARDED. NO PATIENT INFORMATION COULD BE PROVIDED OTHER THAN IT BEING GOOD BONE. NO PICTURES WERE AVAILABLE. PLEASE SEE ALSO MEDWATCH REPORT 1221934-2018-51117.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7660662 ↗

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-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-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-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