N/A 204990Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00848486021849), received between Oct 31, 2018 and Feb 9, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 9, 2023Residue After Decontamination; Residue After Decontamination

  AFTER MULTIPLE WASHES, STERILIZATION AND DETAILED CLEANING, THERE IS PRESENT OIL OR FLUIDS COMING OUT OF SAW ATTACHMENT. ALSO BLACK RESIDUE LEFT ON LIP OF SAW ATTACHMENT THAT IS COMING OFF ON GLOVES BUT IS NOT COMING OFF WITH STERILIZATION. DISCOVERED DURING PRE-OP, NO PATIENT UNDER ANESTHESIA, NO DELAY. CASE TYPE / APPLICATION: PKA 3.0.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16342247 ↗
• MalfunctionAug 12, 2020Fluid/Blood Leak; Leak/Splash; Fluid/Blood Leak; Leak/Splash

  PART IS LEAKING FLUID. PATIENT WAS NOT UNDER ANESTHESIA. CASE TYPE: PKA (MICS).

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10396145 ↗
• MalfunctionOct 15, 2019Fluid/Blood Leak; Contamination of Device Ingredient or Reagent; Fluid/Blood Leak; Contamination of Device Ingredient or Reagent

  PIECE IS LEAKING OIL. CASE TYPE: PKA (MICS). PATIENT UNDER ANESTHESIA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9191239 ↗
• MalfunctionAug 29, 2019Fluid/Blood Leak; Mechanical Problem; Fluid/Blood Leak; Mechanical Problem

  DURING BONE PREPARATION IN A MAKO PKA 3.0 CASE THE SURGEON NOTED THAT THE ROTARY BURR ATTACHMENT WAS HEATING UP AND GETTING HOT DURING USE. UPON FURTHER INVESTIGATION IT WAS NOTICED THERE WAS SOME SORT OF LUBRICANT/OIL BEING RELEASED FROM THE BODY OF THE ROTARY ATTACHMENT (SEE ATTACHED PHOTO). THIS LUBRICANT/OIL WAS ORIGINATING FROM THE ROTARY ATTACHMENT BODY. THE ISSUE WAS NOTICES WHILST THE INSTRUMENT WAS BEING USED BY THE SURGEON.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8946464 ↗
• MalfunctionOct 31, 2018Mechanical Problem; Non Reproducible Results; Mechanical Problem; Non Reproducible Results

  SCRUB REPORTED PLASTIC PIECE STUCK ON BURR AFTER CASE. UNSURE IF PIECE CAME FROM BURR GUARD OR ROTARY ATTACHMENT. CASE TYPE: (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8025718 ↗