MILAGRO 219500Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10886705023196), received between Apr 24, 2018 and Sep 4, 2024 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (9 reports).

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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 4, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY ANTERIOR CRUCIATE LIGAMENT PROCEDURE, IT WAS DISCOVERED THAT THE DRIVER TIP OF THE MILAGRO ADVANCE MODULAR DRIVER DEVICE WAS BENT WHEN THE SCREW WAS INSERTED. IT WAS REPORTED THAT THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE AS A SPARE DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 20135025 ↗
• MalfunctionApr 11, 2023Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE 35MM MODULAR DRIVER - MILAGRO ADVANCE DEVICE BROKE UPON INSERTION. IT WAS UNKNOWN IF AND HOW THE PROCEDURE WAS COMPLETED. 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 16717985 ↗
• MalfunctionApr 4, 2023Material Deformation; Material Deformation

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6)2023, IT WAS OBSERVED THAT THE 35MM MODULAR DRIVER - MILAGRO ADVANCE DEVICE WAS TORQUED/TWISTED UPON INSERTION. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE MODULAR DRIVE WAS DEFORMED AT THE DISTAL PART. ACCORDING TO THE REPORT, THE SCREW WAS FULLY INSERTED AND IMPLANTS WERE COMPLETED 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 16674525 ↗
• MalfunctionSep 27, 2022Material Deformation; Material Deformation

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION ON (B)(6) 2022, IT WAS OBSERVED THAT THE 35MM MODULAR DRIVER - MILAGRO ADVANCE WAS BENT DURING INSERTION. 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 15490397 ↗
• MalfunctionSep 8, 2022Material Deformation; Material Deformation

  IT WAS REPORTED BY SALES REP THAT DURING AN ACL (ANTERIOR CRUCIATE LIGAMENT) RECONSTRUCTION PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE THE 35MM MODULAR DRIVER - MILAGRO ADVANCE DEVICE WAS BENT THAT IT WAS DIFFICULT TO TURN THE SCREW. 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 15382954 ↗
• MalfunctionMar 31, 2022Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN SWEDEN THAT DURING A KNEE ARTHROSCOPY PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE MILAGRO ADVANCE MODULAR DRIVER DEVICE BROKE WHEN TRYING TO TAKE OUT A SCREW. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. 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 13967483 ↗
• MalfunctionFeb 7, 2022Material Deformation; Material Deformation

  IT WAS REPORTED BY SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE MILAGRO ADVANCE MODULAR DRIVER DEVICE GOT BENT AND FAILED TO ADVANCE THE SCREW UPON INSERTION. 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 13475031 ↗
• MalfunctionJun 11, 2021Material Deformation; Material Deformation

  IT WAS REPORTED BY THE SALES REP THAT THE 35MM MODULAR DRIVER - MILAGRO ADVANCE DEVICE WAS BENT. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11986405 ↗
• MalfunctionMay 20, 2021Material Deformation; Material Deformation

  IT WAS REPORTED BY SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE 35MM MODULAR DRIVER - MILAGRO ADVANCE TIP WAS BENT. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WAS NO SURGICAL DELAY NOR ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11858156 ↗
• MalfunctionOct 16, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT THE 35MM MODULAR DRIVER - MILAGRO ADVANCE IS BENT. THE SALES REP DID NOT PROVIDED MORE INFORMATION AT THE TIME OF THE CALL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10689536 ↗
• MalfunctionJul 7, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED BY THE SALES REP THAT THE 35MM MODULAR DRIVER - MILAGRO ADVANCE WAS BENT. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10240762 ↗
• MalfunctionSep 26, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED BY THE SALES REP THAT IT WAS NOTICED DURING AN ACL RECONSTRUCTION PROCEDURE THAT THE CUSTOMER'S MILAGRO ADVANCE MODULAR DRIVER WAS BENT AT THE DISTAL TIP. THE SALES REP DID NOT KNOW HOW THE DEVICE BECAME BENT. THE SALES REP STATED THAT THEY ATTEMPTED TO USE THE DEVICE, BUT THE SCREW WOULD NOT STAY ON. THE CASE WAS COMPLETED WITH ANOTHER LIKE-DEVICE WITH NO PATIENT HARM OR DELAY. THERE WAS NO DELAY IN THE SURGICAL PROCEDURE. THERE WAS A SPARE DEVICE AVAILABLE FOR USE TO COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9122550 ↗
• MalfunctionSep 25, 2019Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN ACL PROCEDURE ON AN UNKNOWN DATE THE CUSTOMER'S 35 MM MODULAR DRIVER MILAGRO ADVANCE DISTAL TIP WAS BENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER LIKE DEVICE WITH NO PATIENT HARM OR DELAYS TO THE CASE. THE SALES REP WAS NOT PRESENT FOR THE CASE THEREFORE COULD NOT PROVIDE ANY FURTHER INFORMATION OR A LOT NUMBER FOR THE DEVICE. THE SALES REP STATED THAT THE DEVICE WAS DISCARDED BY THE CUSTOMER. THERE WAS NO DELAY IN THE SURGICAL PROCEDURE. THERE WAS A SPARE DEVICE AVAILABLE FOR USE TO COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9117412 ↗
• MalfunctionSep 23, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) SURGICAL PROCEDURE, IT WAS OBSERVED THAT MILAGRO ADVANCE MODULAR DRIVER WAS BENT DURING INSERTION. ACCORDING TO THE REPORTER, THERE WAS A LOT OF PRESSURE WAS USED. A NEW DRIVER WAS OPENED TO CONTINUE TO CASE. IT WAS NOT REPORTED IF THERE WAS A DELAY IN THE SURGICAL PROCEDURE. THERE WAS A SPARE DEVICE AVAILABLE FOR USE TO COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9103843 ↗
• MalfunctionSep 23, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED BY THE SALES REP VIA CST THAT DURING A KNEE ARTHROSCOPY WITH ACL RECONSTRUCTION THE MILAGRO ADVANCE DRIVER WAS BEING USED TO INSERT THE MILAGRO ADVANCE SCREWS. THE KNEE WAS SLIGHTLY BENT WHILE THEY WERE INSERTING THE SCREWS TO PROVIDE A BETTER ANGLE, BUT THE MILAGRO ADVANCE DRIVER BENT WHEN THE KNEE WAS BENT. THE CASE WAS COMPLETED WITH ANOTHER LIKE-DEVICE WITH NO PATIENT HARM OR SURGICAL DELAY. THERE WAS NO DELAY IN THE SURGICAL PROCEDURE. THERE WAS A SPARE DEVICE AVAILABLE FOR USE TO COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9103775 ↗
• MalfunctionSep 13, 2019Deformation Due to Compressive Stress; Material Deformation; Material Twisted/Bent; Deformation Due to Compressive Stress; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED BY THE SALES REP THAT THE CUSTOMER'S MILAGRO ADVANCE SCREW DRIVER BENT AT THE TIP DURING AN ACL (ANTERIOR CRUCIATE LIGAMENT) PROCEDURE WHEN PUTTING IN THE SCREW. THERE WERE NO PATIENT CONSEQUENCES OR DELAYS. THE CASE WAS COMPLETED WITH ANOTHER LIKE DEVICE. THE PATIENT HAD HARD BONE. THE DEVICE WAS DISCARDED BY THE CUSTOMER. THERE WAS NO DELAY IN THE SURGICAL PROCEDURE. THERE WAS A SPARE DEVICE AVAILABLE FOR USE TO COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 9028791 ↗
• MalfunctionMay 23, 2018Break; Break

  IT WAS REPORTED VIA PHONE BY THE SALES REP THAT DURING AN ACL PROCEDURE, THE CUSTOMER'S MILAGRO ADVANCE DRIVER TIP STRIPPED AND BROKE OFF IN THE SCREW. THE DOCTOR TAPPED THE BONE FIRST, BUT STATED THE PATIENT HAD HARD BONE. THE DOCTOR WAS ABLE TO REMOVE THE TIP FROM THE SCREW AND USED ANOTHER LIKE DEVICE TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES OR DELAYS. THE COMPLAINT DEVICES ARE BEING RETURNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7536982 ↗
• MalfunctionApr 24, 2018Break; Break

  TIP OF THE DRIVER BROKE OFF WHILE DOCTOR WAS INSERTING SCREW. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7456404 ↗