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NA 111120Recalls & reported problems

Mako Surgical Corp. · SQUARE DRILL ADAPTOR · 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 00848486002725), received between Aug 7, 2019 and Aug 7, 2019 — 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
  • Detachment of Device or Device Component1

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 7, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

    SURGEON WAS TAKING OUT TIBIA BONE PINS AND METAL PIECE FELL OUT OF DRILL. ONCE WE INSPECTED THE DRILL WE SAW THE METAL SIDE ON DRILL HAD BROKEN. CASE TYPE: TKA. UPDATE: "THE PATIENT WAS UNDER ANESTHESIA."

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8871150 ↗

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