NA 143110Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00848486018139), received between Aug 3, 2018 and Mar 23, 2020 — classified as 1 injury, 18 malfunctions.

The most frequently reported specific device problem is “Break” (17 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 23, 2020Break; Fracture; Break; Fracture

  IN BERN SALEM WHILE DOING A PKA CASE WITH DOCTOR THE TIP OF THE PIN BROKE. UPDATE: "1. WAS THE PATIENT IN THE O.R. AT THE TIME OF EVENT? YES; 1. WAS THE PATIENT UNDER ANESTHESIA? YES; 2. DID THE DEVICE BREAK IN THE PATIENT? YES; 1. WERE ALL PIECES REMOVED? MOST PROBABLY; 1. IF SO, HOW WAS THIS VERIFIED? VISUALLY; 2. IF NOT, WHY NOT? MIGHT BE THAT A SMALL PART OF THE TIP REMAINED. ".

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

  MAUDE report 9865013 ↗
• MalfunctionMar 18, 2020Break; Break

  DURING THE FIRST CASE OF THE DAY (PKA) IN (B)(6), THE DOCTOR NOTICED THAT THE 3.2MM PINS BROKE WHILE HE WAS SCREWING. REF143110 LOT W50726-2. UPDATE: 1. WAS THE PATIENT IN THE OPERATING ROOM AT THE TIME OF EVENT? YES. 1. WAS THE PATIENT UNDER ANESTHESIA? YES. 2. DID THE DEVICE BREAK IN THE PATIENT? YES. 1. WERE ALL PIECES REMOVED? NO. 2. IF NOT, WHY NOT? BROKEN PART TOO DEEP IN BONE LEFT OR RIGHT SIDE :RIGHT WAS SURGICAL PROCEDURE COMPLETED MANUALLY (YES/ NO/ NO ASSOCIATED PROCEDURE)? NO, WITH MAKO TILL THE END. RIO SYSTEM DETAILS: O ROB#: (B)(4)"

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

  MAUDE report 9850127 ↗
• MalfunctionFeb 27, 2020Break; Fracture; Break; Fracture

  TIBIA PIN BROKEN OFF IN PATIENT TIBIA WHILE TRYING TO EXTRACT. IT IS BELIEVED PIN WAS HIT WITH KEEL PUNCH WHEN PREPARING TIBIA AND THUS CREATED WEAK POINT. PINS WERE 3.2MM X 110MM MAKO CONSUMABLES. TWO PACKETS OF PINS OPENED FOR BILATERAL CASE SO NOT SURE WHICH LOT NUMBER OF BROKEN PIN. SURGEON NOTED IT WAS ONLY SMALL PIECE AND NO POINT REMOVING.

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

  MAUDE report 9764604 ↗
• MalfunctionFeb 27, 2020Break; Fracture; Break; Fracture

  TIBIA PIN BROKEN OFF IN PATIENT TIBIA WHILE TRYING TO EXTRACT. IT IS BELIEVED PIN WAS HIT WITH KEEL PUNCH WHEN PREPARING TIBIA AND THUS CREATED WEAK POINT. PINS WERE 3.2MM X 110MM MAKO CONSUMABLES. TWO PACKETS OF PINS OPENED FOR BILATERAL CASE SO NOT SURE WHICH LOT NUMBER OF BROKEN PIN. IMAGE ATTACHED. SURGEON NOTED IT WAS ONLY SMALL PIECE AND NO POINT REMOVING.

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

  MAUDE report 9764600 ↗
• 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 9758000 ↗
• MalfunctionSep 17, 2019Break; Fracture; Material Integrity Problem; Break; Fracture; Material Integrity Problem

  MAKO TIBIAL 3.2 X110MM PINS BENT AND BROKE OFF INSIDE PATIENT UPON REMOVAL AT END OF CASE. SEE ATTACHED IMAGES. MAKO 3.2X110MM PINS, ONE ITEM AFFECTED OUT OF PACK OF 2 PROCEDURE: MAKO LEFT TOTAL KNEE.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9076685 ↗
• MalfunctionAug 26, 2019Break; Break

  3.2MM PIN BROKE WHILST PLACING IN TIBIA DURING MAKO TKA. NO MEDICAL RECORDS OR XRAYS AVAILABLE. PIN FULLY RETRIEVED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8932807 ↗
• InjuryAug 14, 2019Break; Non Reproducible Results; Break; Non Reproducible Results

  (B)(6) HAD A PATIENT RECEIVE A STRESS FRACTURE AT THE TIBIAL PIN SITE SIX MONTHS AGO AND IS STILL RECOVERING FROM IT. CASE TYPE: TKA. ADDITIONAL INFORMATION FROM MPS: HERE IS ALL THE INFORMATION I RECEIVED YESTERDAY REGARDING THE STRESS FRACTURE COMPLAINT: PATIENT IS 6 MONTH. POST OP, HAS STRESS FRACTURE AT TIBIAL PIN SITE. PATIENT IS STILL HEALING.

  Patient problems: Bone Fracture(s)

  MAUDE report 8892706 ↗
• MalfunctionJun 28, 2019Break; Non Reproducible Results; Break; Non Reproducible Results

  143110 MAKO 3.2MM X110MM PIN SNAPPED. SOME OF THE PIN IS INSIDE THE PATIENT TIBIA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8743610 ↗
• MalfunctionJun 10, 2019Break; Non Reproducible Results; Break; Non Reproducible Results

  BONE PIN TIP BROKE OFF WHILE DRILLING IT INTO TIBIA. SMALL FRAGMENT/TIP WAS LEFT IN BONE OF PATIENT. CASE TYPE: PKA. UPDATE: "WAS PATIENT IN THE OPERATING ROOM AT THE TIME OF DISCOVERY? OPERATING ROOM WAS PATIENT UNDER ANESTHESIA? YES"

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8684690 ↗
• MalfunctionMay 13, 2019Break; Non Reproducible Results; Break; Non Reproducible Results

  DURING LEFT TOTAL KNEE ARTHROPLASTY WITH ROBOTIC ASSIST, WHILE PLACING THE FIRST GUIDANCE DRILL PIN, THE TIP OF THE PIN BROKE OFF INTO THE TIBIAL CANAL. THE SURGEON DOCUMENTED THE BREAK OCCURRED DUE TO THE PT'S BONE QUALITY. TH SURGEON ELECTED TO RETAIN THE SMALL FRAGMENT AS THE RISKS OF REMOVAL FAR OUTWEIGHED THE RISKS OF RETENTION. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8603037 ↗
• MalfunctionMar 15, 2019Break; Non Reproducible Results; Break; Non Reproducible Results

  AS REPORTED: "3.2 X 110 PIN TIP BROKE OFF IN PATIENT'S RIGHT TIBIA DURING INSERTION FOR PLACEMENT OF MAKO TIBIAL TRACKER". REP REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE FROM THE HOSPITAL OR SURGEON. UPDATE 06/MARCH/2019: SPOKE TO REP. BROKEN PORTION OF THE PIN WAS LEFT IN THE PATIENT. REP CONFIRMED THERE WAS ABSOLUTELY NO SURGICAL DELAY. CASE TYPE TKA. SURGERY WAS NOT COMPLETED MANUALLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8425989 ↗
• MalfunctionFeb 6, 2019Break; Non Reproducible Results; Break; Non Reproducible Results

  TIP OF MAKO 3.2MM PIN BROKE IN FEMUR WHEN PLACING AT START OF MAKO TKA PIN FAILED TO FIX INTO BONE, NOTED ON BACKING OUT PIN. X-RAY CONFIRMED TIP EMBEDDED IN POSTERIOR CORTEX OF FEMUR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8310035 ↗
• MalfunctionJan 31, 2019Fracture; Non Reproducible Results; Fracture; Non Reproducible Results

  ONE 3.2MM X 110MM PIN BROKE OFF IN PATIENT BONE (TIBIA) UPON EXTRACTION AT END OF CASE. SURGEON BELIEVES HE MAY HAVE HIT THE PIN UPON PUNCHING THE TIBIAL KEEL CAUSING IT TO BREAK OR BECOME WEAK.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8294480 ↗
• MalfunctionDec 13, 2018Break; Break

  MAKO TIBIAL PIN (3.2 X 110MM) SNAPPED INSITU UPON REMOVAL. SURGICAL DELAY<15 MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8161726 ↗
• MalfunctionSep 19, 2018Break; Non Reproducible Results; Break; Non Reproducible Results

  A SMALL PIECE OF A TIBIAL PIN 3.2X110 REF 143110 LOT W53978-1 BLOKE AND REMAINED IN THE PATIENT¿S TIBIA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7888887 ↗
• MalfunctionAug 10, 2018Break; Non Reproducible Results; Break; Non Reproducible Results

  WHEN PUTTING IN FIRST TIBIA 3.2 X 110 MM PIN FOR TIBIA ARRAY, PIN WOULD NOT ADVANCE. SURGEON PULLED PIN OUT AND REALIZED THE TIP OF THE PIN WAS MISSING. PKA. DR. (B)(6) PULLED THE DRILL WITH THE PIN IN IT OUT AFTER IT WOULD NOT ADVANCE AND REALIZED THE TIP OF THE PIN WAS MISSING. TIP OF PIN COULD NOT BE RETRIEVED FROM PATIENT. SURGICAL DELAY APPROXIMATELY 3 MINUTES, ATTEMPTING TO RETRIEVE TIP OF PIN AND OPEN A NEW DISPOSABLE PACK OF PINS TO USE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7772325 ↗
• MalfunctionAug 3, 2018Break; Non Reproducible Results; Break; Non Reproducible Results

  AFTER THE TKA MAKO CASE WAS DONE IT WAS NOTICED THE EXTRA-INCISION BONE PIN TIPS ON THE 3.2X110 BONE PINS USED HAD BOTH BROKEN OFF INSIDE THE PATIENT BONE. WHICH WERE LEFT INSTEAD OF BEING REMOVED. THIS IS THE 2ND INCIDENT AT OUR LOCATION ANY INFORMATION WOULD BE BENEFICIAL. SURGICAL DELAY: 16-30 MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7746996 ↗
• MalfunctionAug 3, 2018Break; Non Reproducible Results; Break; Non Reproducible Results

  AFTER THE TKA MAKO CASE WAS DONE IT WAS NOTICED THE EXTRA-INCISION BONE PIN TIPS ON THE 3.2X110 BONE PINS USED HAD BOTH BROKEN OFF INSIDE THE PATIENT BONE. WHICH WERE LEFT INSTEAD OF BEING REMOVED. THIS IS THE 2ND INCIDENT AT OUR LOCATION. ANY INFORMATION WOULD BE BENEFICIAL. SURGICAL DELAY: 16-30 MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7746995 ↗