NA 143080Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00848486018122), received between Jun 11, 2018 and Oct 16, 2018 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Non Reproducible Results” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 16, 2018Break; Non Reproducible Results; Break; Non Reproducible Results

  3.2MM MAKO PIN TIP BROKE OFF IN PATIENT TIBIA WHILST REMOVING PIN AT END OF MAKO TKA CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7970485 ↗
• MalfunctionJul 13, 2018Break; Non Reproducible Results; Break; Non Reproducible Results

  THE TIP OF THE 3.2X80MM BONE PIN WAS NOT INTACT WHEN THE SURGEON REMOVED THE PIN FROM THE PATIENT'S TIBIA. CASE TYPE: PKA. WAS THERE A SURGICAL DELAY? YES - =15 MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7685494 ↗
• MalfunctionJun 11, 2018Material Integrity Problem; Non Reproducible Results; Material Integrity Problem; Non Reproducible Results

  DOCTOR REMOVED THE REFERENCE TIP FROM THE TIBIA AND THE TIP WAS MISSING IN THE BONE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7586295 ↗