NA 213524Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327412369), received between Dec 3, 2018 and Mar 6, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (4 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.

• MalfunctionMar 6, 2025Fracture; Fracture

  THE TIP OF THE MAKO BONE PIN 3.2MM×110MM BROKE WHILE IT WAS BEING INSERTED INTO THE TIBIA AND REMAINED INSIDE THE BONE. IT WAS POSSIBLE TO REMOVE IT BY EXCAVATING AROUND THE REMAINED PIN USING A CHISEL AND K-WIRE. A DEFECT WAS CREATED IN THE ANTERIOR CORTICAL BONE OF THE TIBIA, AND THE SURGERY TIME WAS EXTENDED BY 10 MINUTES.

  Patient problems: Bone Notching; Foreign Body In Patient

  MAUDE report 21539975 ↗
• MalfunctionOct 1, 2019Break; Non Reproducible Results; Break; Non Reproducible Results

  ON (B)(6) 2019 DURING A MAKO TKA PROCEDURE DR. (B)(6) WAS TRIALING THE NEWLY DESIGNED 3.2X110 BONE PINS. DR. (B)(6) PUT BOTH THE 3.2X110 BONE PINS INTO THE TIBIA AND PLACED THE TIBIA ARRAY ON. THE TKA PROCEDURE WAS COMPLETED SUCCESSFULLY, WHEN DR. (B)(6) WENT TO TAKE THE TIBIA ARRAY OFF THE TIBIA AND REMOVE THE 3.2X110MM BONE PINS ONE THE PINS TIP WAS BROKEN OFF. DR. (B)(6) SHOWED ME THIS AND TOLD ME HE NEVER WANTED TO USE THESE PINS AGAIN. THIS IS THE SAME PROBLEM DR. (B)(6) HAD WITH THE PREVIOUS DESIGN ON THESE BONE PINS. I LOOKED AT BOTH PINS AND ONE DEFIANTLY WAS MISSING THE TIP. BOTH 3.2X110MM BONE PINS WERE CLEANED AND STERILIZED IN ORDER TO SEND THEM BACK. CASE TYPE: TKA. UPDATE: BONE BIN BROKE IN THE PATIENT WHEN THE EVENT OCCURRED, DEBRIS/COMPONENTS LEFT INSIDE THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9141318 ↗
• MalfunctionSep 25, 2019Break; Fracture; Break; Fracture

  PRIMARY LEFT MAKO TKA. IT WAS REPORTED THAT A BONE PIN BROKE IN THE PATIENT'S TIBIA. THE SURGEON REPORTED THE PORTION IN THE PATIENT'S BONE WOULD NOT BE REMOVED AS THE REMOVAL WOULD CAUSE MORE HARM TO THE PATIENT. SURGERY WAS COMPLETED WITH NO DELAY. PATIENT'S BONE QUALITY WAS "GOOD". THE REP WAS NOT PRESENT FOR THE PROCEDURE AND DOES NOT KNOW WHICH OF THE HOSPITAL'S 3 ROBOTS WERE USED. THE REP MAY BE ABLE TO OBTAIN THE OPERATIVE REPORT AND POST-OP X-RAYS, BUT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Foreign Body In Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9119596 ↗
• MalfunctionSep 17, 2019Break; Material Integrity Problem; Break; Material Integrity Problem

  DR. (B)(6) STATES THAT WHEN DRILLING THE 3.2 BONE PIN INTO THE TIBIA THERE WAS AN ODD SOUND. INTRA-INCISIONAL TIBIA PINS WERE DETERMINED TO BE LOW ENOUGH TO NOT INTERFERE WITH PRESS FIT PUNCH OR IMPLANT. UPON REMOVING THE PIN IT WAS DISCOVERED THAT AN ABOUT A CM OF THE THREADS HAD SHEARED OFF AND WAS LEFT IN PATIENT BONE. A POST OP X-RAY IS SCHEDULED TO DETERMINE IF PIN CAUSED A CRACK IN BONE. CASE TYPE: NOT REPORTED

  Patient problems: Foreign Body In Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9077669 ↗
• MalfunctionDec 3, 2018Break; Non Reproducible Results; Break; Non Reproducible Results

  PIN (213524) TIP BROKE OFF IN TIBIA UPON INSERTION. SURGEON ATTEMPTED TO PUT PIN IN TIBIAL CREST OF MALE PATIENT WITH DENSE BONE (ACCORDING TO SURGEON). CASE TYPE: PKA. POST X-RAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8125796 ↗