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RIO 111430Recalls & reported problems

Mako Surgical Corp. · KNEE APPLICATION DUAL PIN BASE CLAMP · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00848486002770), received between Aug 24, 2018 and Aug 24, 2018 — classified as 1 malfunction.

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

Most reported problems

Device problems

  • Break1
  • Material Integrity Problem1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 24, 2018Break; Material Integrity Problem; Break; Material Integrity Problem

    PKA DR (B)(6) WAS TIGHTENING THE ARRAY CLAMP ONTO THE FEMORAL BONE PIN, WHEN THE TIGHTENING MECHANISM SNAPPED. THE BONE PINS WERE STUCK INSIDE OF THE CLAMP AND WERE TAKEN OUT WITH BOLT CUTTERS AND THE PIN DRIVER. SURGICAL DELAY YES, 25 MINUTES-YES, THE PATIENT WAS UNDER ANESTHESIA.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7812507 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.