MILAGRO 231811Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886705020416), received between Jul 31, 2018 and Jun 15, 2026 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 15, 2026Difficult to Advance

  IT WAS REPORTED THAT DURING AN UNSPECIFIED FEMORAL-SIDE SURGERY FOR A ¿BTB¿ A 7X15 MM MILAGRO INTERFERENCE SCREW WAS USED. THE BONE WAS NOT ESPECIALLY WEAK. TAPPING FELT GOOD. A 7X15 MM SIZE HAD BEEN CHOSEN AS USUAL, BUT FIXATION OF THE SCREW FELT INSECURE. THEREFORE, THE SIZE WAS CHANGED TO 8X23 MM. THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE. 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 25503509 ↗
• MalfunctionMar 29, 2023Difficult to Advance; Difficult to Advance

  IT WAS REPORTED BY THE AFFILIATE IN JAPAN THA DURING A LONG HEAD OF BICEPS TENDON REPAIR PROCEDURE ON (B)(6), 2023, A 7X15MM MILAGRO INTERFERENCE SCREW DEVICE WAS USED. ACCORDING TO THE REPORT, THE SURGEON TRIED TO INSERT THE DEVICE AND FIX USING A GUIDE PIN. IT WAS REPORTED THAT AT FIRST, THE DEVICE WENT IN WITH EACH TURN OF THE SCREWDRIVER BUT IT SLIPPED AND FELL INTO THE BURR HOLE AFTER ABOUT THE THIRD TURN. IT WAS REPORTED THAT THE DEVICE WAS REMOVED BY THE FORCEPS. 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 16639728 ↗
• InjuryJul 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A REVIEW OF NEW ZEALAND ACL REGISTRY DEPUY IMPLANT REPORT RECEIVED AS PER IIS (B)(4) CONTRACT MILESTONE DELIVERABLE THAT POSTOPERATIVELY TO AN ANTERIOR CRUCIATE LIGAMENT PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE 7X15MM MILAGRO INTERFERENCE SCREW DEVICE FAILED THAT REQUIRED A REVISION SURGERY. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 14991119 ↗
• MalfunctionJan 26, 2021Difficult to Advance; Difficult to Advance

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A BICEPS TENDON FIXATION PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE 7X15 MILAGRO INTERFRENCE SCREW DEVICE WAS NOT ABLE TO BE FIXATED THAT IT CAME OFF AFTER INSERTION. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. THE DEVICE WAS THE FIRST USE WHEN THE ISSUE OCCURRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11231223 ↗
• MalfunctionJul 31, 2018Break; Break

  THE SALES REP REPORTED THAT UPON INSERTION THE SPIRAL AREA OF THEMILAGRO BR SCREW, 7 X 15 MM FRACTURED. THE FRACTURED SCREW WAS REMOVED AND A NEW LIKE SCREW WAS USED AND REPOSITIONED IN THE SHOULDER. THE FRACTURED SCREW WAS DISCARDED. THE SALES REP REPORTED THAT THERE WAS A 5 MINUTE DELAY AND NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7736593 ↗