NA 143140Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00848486018146), received between Jun 4, 2018 and Jun 13, 2022 — classified as 2 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Fracture” (8 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryJun 13, 2022Fracture; Fracture

  THE 3.2 X 140 PINS USED TO PLACE THE FEMORAL ARRAY, WHEN BEING REMOVED WITH A DRILL, ONE PIN BROKE OFF IN THE FEMUR. THE PA REMOVING PIN DID NOT CATCH THAT IT WAS BROKEN AND PATIENT WAS SENT TO PACU WHERE A POST OP X-RAY DETECTED THE HALF BROKEN OFF. PATIENT WAS BROUGHT BACK AND THE REMAINING PIN WAS REMOVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 14675020 ↗
• MalfunctionFeb 26, 2020Fracture; Fracture

  DURING THE TKA OPERATION USING MAKO, DRILLED THE BONE PIN TO THE FEMORAL SHAFT TO PLACE THE FEMORAL ARRAY. THE TIP OF THE PIN BROKE WHEN IT REACHED THE SECOND CORTEX. REPLACED WITH ANOTHER PIN, BUT IT ALSO BROKE. THE THIRD PIN COULD BE PLACED, AND OPERATION WAS COMPLETED. HOWEVER, AFTER OPERATION, X-RAY CONFIRMED THREE BROKEN PIECE REMAINED IN THE PATIENT BONE. THOSE COULD NOT BE REMOVED, SO THOSE WERE LEFT AND OPERATION WAS FINISHED.

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

  MAUDE report 9752999 ↗
• MalfunctionFeb 25, 2020Fracture; Fracture

  DURING THE TKA OPERATION USING MAKO, DRILLED THE BONE PIN TO THE FEMORAL SHAFT TO PLACE THE FEMORAL ARRAY. THE TIP OF THE PIN BROKE WHEN IT REACHED THE SECOND CORTEX. REPLACED WITH ANOTHER PIN, BUT IT ALSO BROKE. THE THIRD PIN COULD BE PLACED, AND OPERATION WAS COMPLETED. HOWEVER, AFTER OPERATION, X-RAY CONFIRMED THREE BROKEN PIECE REMAINED IN THE PATIENT BONE. THOSE COULD NOT BE REMOVED, SO THOSE WERE LEFT AND OPERATION WAS FINISHED.

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

  MAUDE report 9750243 ↗
• MalfunctionFeb 25, 2020Fracture; Fracture

  IN TKA SURGERY USING MAKO, TO PLACE THE FEMORAL ARRAY ON THE FEMUR, DRILLED THE BONE PIN. IT GOES THROUGH THE ANTERIOR CORTEX AND REACHES THE OPPOSITE CORTEX. THE TIP OF THE PIN WAS BROKEN, AND THE TIP WAS EMBEDDED IN THE BONE. AT THE DOCTOR'S DISCRETION, ANOTHER PIN WAS USED TO PLACE THE PIN AT ANOTHER LOCATION, AND THE OPERATION WAS COMPLETED. HOWEVER, AFTER THE OPERATION, AN X-RAY WAS TAKEN AND CONFIRMED THE BROKEN TIP HAS REMAINED IN THE BONE. SINCE REMAINED INSIDE THE BONE, THE OPERATION HAS BEEN COMPLETED WITHOUT REMOVING IT.

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

  MAUDE report 9749619 ↗
• MalfunctionFeb 25, 2020Fracture; Fracture

  DURING SURGERY USING THE MAKO TOTAL KNEE SYSTEM, A PIN (3.2 MM X 140 MM) WAS INSERTED USING A HOSPITAL-OWNED HANDPIECE / PIN COLLET TO INSTALL AN ARRAY ON THE FEMUR SIDE.THE INNER CORTICAL BONE WAS PERFORATED WITHOUT ANY PROBLEM, BUT THE PIN STOPPED MOVING WHEN IT CAME INTO CONTACT WITH THE OUTER CORTICAL BONE. WHEN THE SURGEON REMOVED THE PIN COLLET AND MANUALLY CHECKED THE PIN'S FIXATION, HE DETERMINED THAT IT WAS SUFFICIENT TO FIX THE ARRAY AND CONTINUED THE OPERATION. WHEN THE PIN WAS REMOVED AFTER THE IMPLANT WAS INSTALLED, THE NURSE NOTICED A BREAK IN THE TIP OF THE PIN, AND WHEN CONFIRMED BY X-RAY AFTER THE OPERATION, A METAL PIECE OF ABOUT 3 MM WAS FOUND OUTSIDE THE DIAPHYSIS. THE OPERATION IS COMPLETED WITHOUT REMOVAL AT THE DISCRETION OF THE DOCTOR.

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

  MAUDE report 9749565 ↗
• MalfunctionFeb 4, 2020Fracture; Fracture

  TKA WAS PERFORMED WITH MAKO SYSTEM. TO LOCATE FEMORAL ARRAY, BONE PIN WAS DRILLED INTO FEMORAL SHAFT. TRIED TO FIX BICORTICALLY, BUT COULDN'T DRILL INNER CORTEX. REMOVED BONE PIN AND FOUND TIP OF THE PIN BROKEN. USED ANOTHER BONE PIN. THE TIP OF THE IN WAS REMAINED IN FEMORAL INTRASPINAL. IMPOSSIBLE TO REMOVE BROKEN PIECE, SO FINISHED SURGERY WITHOUT REMOVING IT. UPDATE: " PLEASE ESTIMATE ANY SURGICAL DELAY, EVEN IF UNDER A MINUTE (OR INDICATE ¿NONE¿ TO CONFIRM THERE WAS ABSOLUTELY NO DELAY): APPROXIMATELY 10 MINUTES".

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

  MAUDE report 9664952 ↗
• MalfunctionDec 19, 2019Fracture; Fracture

  THE TIP OF BONE PIN WAS BROKEN IN THE SURGICAL FIELD. AFTER SURGICAL PROCEDURE, THIS WAS NOTICED BECAUSE OF X-RAY. EXTRACTION WAS NOT PERFORMED, AND THE SURGERY WAS FINISHED WITH BROKEN PIECE LEFT IN THE PATIENT BODY. CASE TYPE: TKA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9498355 ↗
• MalfunctionNov 26, 2019Fracture; Fracture

  SMALL END PIECE OF WORK ONE 3.2MM X 140MM BONE BIN FOUND TO BE MISSING WHEN PINS REMOVED FROM FEMUR AT COMPLETION OF OPERATION. SMALL PIECE REMAINS IN PATIENT BONE. MALE PATIENT UNDERGOING L) TKA. PIECE OF PIN REMAINS IN PATIENT. WILL REQUIRE X-RAY TO DETERMINE POSITION AND IF ANY FURTHER ACTION REQUIRED. NO SURGICAL DELAY OR EFFECT ON PROCEDURE.

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

  MAUDE report 9378222 ↗
• InjuryFeb 5, 2019Use of Device Problem; Non Reproducible Results; Use of Device Problem; Non Reproducible Results

  PATIENT EXPERIENCED FRACTURE AT FEMORAL PIN SITE POST OP THE PIN WAS REMOVED AND DISCARDED AFTER THE CASE. A FEW WEEKS AFTER THE CASE, THE PATIENT¿S FEMUR FRACTURED WHERE THE PIN WAS. THE PIN IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED AFTER THE CASE. CASE TYPE: TKA.

  Patient problems: Bone Fracture(s)

  MAUDE report 8306999 ↗
• MalfunctionDec 5, 2018Break; Non Reproducible Results; Break; Non Reproducible Results

  WHEN RETRIEVING A PIN 3.2X140 REF143140 LOTW53705 FROM THE PATIENT¿S FEMUR, WE NOTICED THAT IT WAS BROKEN AND THAT A PIECE OF IT REMAINED DEEP IN THE BONE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8134797 ↗
• MalfunctionNov 28, 2018Break; Non Reproducible Results; Break; Non Reproducible Results

  TIP OF TIBIAL BONE PIN BROKE OFF UPON INSERTION OF SECOND CORTICAL. CASE TYPE: (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8112761 ↗
• MalfunctionAug 15, 2018Break; Non Reproducible Results; Break; Non Reproducible Results

  ONE OF THE 3.2X140 BONE PINS BROKE OFF IN THE FEMUR OF A PATIENT. SURGEON IS LEAVING THE TIP OF THE PIN IN THE PATIENT. SURGICAL DELAY- 15 MINUTES; CASE TYPE: PKA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7786670 ↗
• MalfunctionJun 11, 2018Material Integrity Problem; Non Reproducible Results; Material Integrity Problem; Non Reproducible Results

  DOCTOR SLAPPEY WAS INSERTING HIS FIRST 3.2 X 140MM TIBIAL PIN AND THE TIP BROKE OFF IN THE PATIENT¿S BONE. HE USED X-RAY TO DETERMINE THE TIP WAS EMBEDDED IN BONE AND NOT FLOATING AND DECIDED TO LEAVE IT IN AND SWITCH TO 4.0 X 140MM PINS AND COMPLETED THE CASE ROBOTICALLY WITH MINIMAL DELAY. DOCTOR SLAPPEY ADMITTED THE FAILURE COULD HAVE BEEN DUE TO HOW HE INSERTED THE PIN (AT AN ANGLE AND WITH TOO MUCH TORQUE) BUT WE STILL DECIDED TO MOVE TO 4.0 PINS. TKA PROCEDURE DELAYED =15 MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7586220 ↗
• MalfunctionJun 4, 2018Material Integrity Problem; Non Reproducible Results; Material Integrity Problem; Non Reproducible Results

  THE 3.2 BONE PIN WAS BEING USED ON TIBIA AND THE TIP OF THE 3.2 PIN BROKE OFF IN THE BONE AS HE WAS DRILLING. THE DOCTOR BACKED THE BROKEN PIN OUT AND MADE A NEW INCISION AND OPENED A NEW PIN AND CONTINUED THE CASE. THE DOCTOR WAITED UNTIL THE END OF THE CASE TO ASSESS THE BROKEN TIP AND USED C-ARM TO DECIDE THAT IT WAS NOT GOING TO HARM THE PATIENT AND DECIDED TO LEAVE IT IN THE BONE. TKA CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7565037 ↗