MILAGRORecalls & reported problems across all models
Depuy Mitek, LLC · 10 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 88
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls
- 0
We found 10 models of MILAGRO by Depuy Mitek, LLC in the FDA's device registry (GUDID). Together they are named in 88 adverse event reports in the FDA's MAUDE database, received between Jan 3, 2018 and Sep 29, 2026 — classified as 9 injuries, 79 malfunctions.
The most frequently reported specific device problem is “Break” (58 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported MILAGRO problems
Device problems
- Break58
- Material Deformation9
- Material Twisted/Bent6
- Adverse Event Without Identified Device or Use Problem5
- Deformation Due to Compressive Stress4
- Difficult to Advance4
- Crack3
- Migration or Expulsion of Device2
Patient problems
- No Clinical Signs, Symptoms or Conditions40
- No Consequences Or Impact To Patient38
- No Code Available5
- Not Applicable4
- Unspecified Infection4
- No Known Impact Or Consequence To Patient2
- Tissue Damage2
- Abscess1
MILAGRO models
10 models, most reported first. Each model has its own page with its reports, recalls and device details.
- MILAGRO 231800Screw, fixation, bone26 reports
- MILAGRO 231810FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE23 reports
- MILAGRO 231815FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE11 reports
- MILAGRO 231820FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE9 reports
- MILAGRO 231805FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE5 reports
- MILAGRO 231825Screw, fixation, bone5 reports
- MILAGRO 231835FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE5 reports
- MILAGRO 231850FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE2 reports
- MILAGRO 231840FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE1 report
- MILAGRO 231855FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE1 report
Recent MILAGRO adverse event reports
The 15 most recent reports across all models, 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 ↗MalfunctionMay 11, 2026Break
IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ANTERIOR CRUCIATE LIGAMENT REPAIR PROCEDURE THE MILAGRO INTSCR 9X23MM ANCHOR DEVICE BROKE. ALL BROKEN PIECES 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. THIS IS REPORT 2 OF 3 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25142462 ↗MalfunctionDec 15, 2025Break; Break
IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT PROCEDURE, WHILE USING THE MILAGRO INTSCR 7X23MM AND THE TRUESPAN 12 DEGREE PEEK DEVICES, AFTER 1ST FIRING, COULD NOT FIRE AGAIN. WHEN INSERT THE SCREW, THE SCREW'S WAS BROKEN, ALL THE PIECES WERE REMOVED FROM THE PATIENT. ANOTHER DEVICES WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 2 FOR THE SAME EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23804905 ↗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 ↗MalfunctionMay 5, 2025Break; Break
IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY PROCEDURE, IT WAS OBSERVED THAT THE SCREW OF THE MILAGRO INTSCR 7X23MM DEVICE BROKE OFF UPON INSERTION. 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 21959777 ↗MalfunctionApr 30, 2025Break; Break
IT WAS REPORTED THAT DURING AN UNKNOWN SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE MILAGRO INTSCR 7X30MM *EA DEVICE ANCHOR WAS BROKEN OFF, REMOVED ALL BROKEN PARTS. 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 21933750 ↗MalfunctionMar 19, 2025Break; Break
IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE MILAGRO INTSCR 9X23MM ANCHOR DEVICE WAS BROKEN OFF. IT WAS REPORTED THAT 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 21646902 ↗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 28, 2025Break; Break
IT WAS REPORTED THAT DURING A CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE IT WAS OBSERVED THAT THE MILAGRO INTSCR 7X23MM ANCHOR DEVICE WAS BROKEN OFF. IT WAS REPORTED THAT ALL BROKEN PARTS WERE REMOVED FROM THE PATIENT. 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 21252888 ↗MalfunctionJan 23, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT REPAIR SURGERY, IT WAS OBSERVED THAT WHEN THE MILAGRO INTSCR 7X23MM DEVICE ANCHOR WAS INSERTED, IT WAS NOTED THAT THE ANCHOR WAS PEELED. 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 21218681 ↗
Other Depuy Mitek, LLC products
- VAPR30 models · 1,986 reports
- HEALIX ADVANCE6 models · 873 reports · 2 recalls
- VAPR COOLPULSE2 models · 779 reports
- FMS9 models · 434 reports
- BIOKNOTLESS PANACRYL ETHIBOND3 models · 35 reports · 2 recalls
- LUPINE ORTHOCORD4 models · 112 reports
- QUICKANCHOR ETHIBOND TAPERCUT2 models · 104 reports
- INTRAFIX14 models · 91 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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