Aequalis Reversed II MWB107Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03700386968709), received between Dec 4, 2018 and Jun 19, 2026 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 19, 2026Fracture

  DURING THE STANDARD INTRAOPERATIVE PROCEDURE, IT WAS DISCOVERED THAT THE TIP OF THE DRILL BIT WAS MISSING. SUSPECTING REMAINING THE BROKEN TIP IN THE PATIENT'S BODY, THE BASE PLATE, WHICH WAS ALREADY IMPLANTED IN THE PATIENT, WAS REMOVED FOR INSPECTION. AFTER THE SURGERY, THE DISTRIBUTOR CHECKED THE PHOTO, WHICH WAS TAKEN BETWEEN CLEANING COMPLETION AND STARTING STERILIZATION BEFORE SURGERY, AND FOUND THAT THE TIP OF THE DRILL BIT WAS ALREADY GONE AT THAT TIME.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25566194 ↗
• InjuryApr 25, 2025Break; Fracture; Break; Fracture

  WHILE DRILLING FOR THE BASEPLATE SCREWS, THE DRILL BIT BROKE WITHIN THE PATIENTS SCAPULA. THE DRILL WAS TOO FAR IN THE EXTRACT SO SURGEON PLACED SHORTER SCREW IN THE SAME HOLE. THE DRILL STILL IN PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 21912357 ↗
• MalfunctionFeb 25, 2022Fracture; Fracture

  THIS PATIENT HAD A SURGERY OF AEQUALIS REVERSED. WHEN THE ''DIA 3MM DRILL BIT (220MM)''WAS USED, THE DRILL TIP PART GOT STUCK AND COULDN'T PULL OUT. IT WAS MANAGED TO PULL OUT FORCEDLY, BUT THE DRILL TIP PART GOT BROKED. THIS DRILL TIP PART COULDN'T BE PULLED OUT , SO IT HAD TO REMAIN INSIDE THE BODY. ACCORDING TO THE SURGEON,THIS CASE WAS CAUSED BY A TECHNICAL ERROR. HE COULD NOT PULL OUT BECAUSE THE DRILL TIP PART WAS CLOGGED IN THE CORACOID PROCESS OF SCAPULA. THE DRILL IS USUALLY USED WITH CAUTION, BUT THIS TIME IT TOOK TOO LONG HANDLING THE DRILL. THE REVISION SURGERY WAS CARRIED OUT ON JUNE 6,AND THE BROKEN DRILL TIP WAS REMOVED WITHOUT ANY PROBLEM.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 13606871 ↗
• MalfunctionDec 4, 2018Material Fragmentation; Material Fragmentation

  DURING DRILLING THE INFERIOR PERIPHERAL HOLE FOR THE BASEPLATE FIXATION: THE DRILL BIT BROKE OFF AND HAS BEEN LEFT INSIDE THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8128333 ↗