NA 210195Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00848486031947), received between May 22, 2019 and Jun 26, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Damaged by Another Device” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 26, 2019Material Deformation; Material Integrity Problem; Material Deformation; Material Integrity Problem

  GAUGED RETRACTOR FOUND IN CPD WHILE PROCESSING TRAYS. CASE TYPE: NO ASSOCIATED PROCEDURE. UPDATE: "THE RETRACTORS GET GAUGED AFTER PERFORMING SEVERAL MAKO CASES DUE TO THE SAW BLADE HITTING THEM DURING CUTTING."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8736422 ↗
• MalfunctionMay 22, 2019Device Damaged by Another Device; Non Reproducible Results; Device Damaged by Another Device; Non Reproducible Results

  GAUGES IN RETRACTOR (FOUND IN CPD). CASE TYPE: NO ASSOCIATED PROCEDURE. CAN WE PLEASE CONFIRM HOW AND WHEN THE RETRACTORS BECAME DAMAGED? DURING THE PROCEDURE OR IN CPD? AS PER THE MPS: "I CANNOT SAY EXACTLY WHEN THEY WERE DAMAGED SINCE THEY WERE FOUND IN CPD, BUT MY BEST GUESS IS DURING THE PROCEDURE DUE TO THE IMPACT OF THE SAW".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8633312 ↗