PANGEA 542110Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327625042), received between Jul 2, 2026 and Aug 26, 2026 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50459567 ↗
• MalfunctionAug 5, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50147215 ↗
• InjuryJul 28, 2026Fracture

  As reported: "The surgeon was drilling using 542110 through the targeter. The drill bit broke inside of the tibial canal attempting to drill through the far cortex.The tip of the drill bit that broke off stayed inside the tibia. The surgeon decided it would cause more harm than good to try and fish the broken piece out of the tibia."

  Patient problems: Foreign Body In Patient

  MAUDE report 50061368 ↗
• MalfunctionJul 2, 2026Fracture

  AS REPORTED: "THE SURGEON WAS DRILLING USING 542110 THROUGH THE TARGETER. THE DRILL BIT BROKE INSIDE OF THE TIBIAL CANAL ATTEMPTING TO DRILL THROUGH THE FAR CORTEX."

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 25690343 ↗