NA 116230Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00848486002978), received between Oct 19, 2018 and Feb 10, 2026 — classified as 3 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Fracture” (6 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 10, 2026Fracture

  THE FOLLOWING INFORMATION WAS PROVIDED: WHEN REMOVING THE 3.5MM HEX CHECKPOINT FROM THE PELVIS, THE SCREW PORTION BROKE OFF FROM THE TOP OF IT. SURGEON ELECTED TO NOT REMOVE IT SINCE IT WAS DIFFICULT TO FIND. CASE TYPE / APPLICATION: THA 4.1.

  Patient problems: Insufficient Information

  MAUDE report 24303029 ↗
• MalfunctionJan 19, 2026Fracture

  THE FOLLOWING INFORMATION WAS PROVIDED: DURING CHECKPOINT REMOVAL PRIOR TO WOUND CLOSURE, EXTRACTION REQUIRED ADDITIONAL TIME USING A DRIVER. AFTER REMOVAL, THE CHECKPOINT TIP WAS FOUND CHIPPED. NO RESIDUAL FRAGMENTS WERE DETECTED IN THE WOUND; HOWEVER, SMALL METAL FRAGMENTS WERE OBSERVED WITHIN THE REAMED BONE. THE WOUND WAS IRRIGATED BEFORE AND AFTER IMPLANT INSERTION, CONFIRMING NO RESIDUAL MATERIAL REMAINED. WOUND CLOSURE PROCEEDED, AND POSTOPERATIVE X-RAY CONFIRMED NO RESIDUAL FOREIGN MATERIAL INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24108889 ↗
• MalfunctionDec 23, 2025Use of Device Problem; Use of Device Problem

  DURING ACETABULAR REAMING AT MTHA, THE CHECKPOINT SCREW HEX 3.5MM INSTALLED IN THE PELVIS WAS ACCIDENTALLY SHAVED OFF. THE SCREW WAS WORN DOWN INSIDE THE BODY.

  Patient problems: Foreign Body In Patient

  MAUDE report 23879853 ↗
• MalfunctionNov 27, 2025Material Fragmentation; Use of Device Problem; Material Fragmentation; Use of Device Problem

  DURING REAMING WITH MAKO, THE BONE WAS TOO HARD TO CUT. MANUAL REAMING WAS PERFORMED USING THE HANDPIECE MICS. SUBSEQUENTLY, THE CHECK PIN DISLODGED DURING THE PROCEDURE. POSTOPERATIVELY, THE CHECK PIN WAS EXAMINED AND FOUND TO HAVE A WORN TIP. ADDITIONALLY, UPON INSPECTION OF THE REAMED BONE POSTOPERATIVELY, POWDER-LIKE PARTICLES RESEMBLING METAL FRAGMENTS WERE OBSERVED. UPDATE: WHY WAS MANUAL REAMING PERFORMED? WAS THE DEVICE CAUSING ANY ISSUES? THE PATIENT¿S BONE QUALITY WAS HARD. WAS THERE ANY POWDER LIKE PARTICLES OBSERVED ACTUALLY AS THE ADVERSE CONSEQUENCES MENTION THAT THERE WERE NO PARTICLES POST X RAY WAS DONE?: YES. UPON EXAMINING THE REAMED BONE, POWDERY MATERIAL BELIEVED TO BE METAL FRAGMENTS WAS OBSERVED. WHY WAS A BONE GRAFT PERFORMED? WAS IT DUE TO DEVICE CAUSING ISSUES?: IT WAS NORMAL PROCEDURE. IT IS NOT RELATED THE EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 23665490 ↗
• MalfunctionOct 20, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  THE ACETABULAR CHECKPOINT PIN LOOSENED AND STRAYED POSTERIORLY INTO THE PELVIS. THE PIN WAS REMOVED USING AN X-RAY IMAGE INTENSIFIER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23334682 ↗
• InjurySep 19, 2025Positioning Failure; Positioning Failure

  DURING INSERTION OF CHECKPOINT PIN 116230 INTO THE PELVIS, IT ACCIDENTALLY PENETRATED THE ILIAC BONE AND WAS IMPLANTED INTO THE ABDOMINAL CAVITY. MAKO THA WAS COMPLETED WITHOUT ANY PROBLEMS.

  Patient problems: Insufficient Information

  MAUDE report 23097777 ↗
• MalfunctionAug 19, 2025Material Fragmentation; Material Fragmentation

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22838634 ↗
• InjuryJul 30, 2025Break; Material Fragmentation; Break; Material Fragmentation

  PELVIC PIN BROKEN OFF.

  Patient problems: Foreign Body In Patient

  MAUDE report 22663299 ↗
• MalfunctionJun 12, 2025Material Fragmentation; Improper or Incorrect Procedure or Method; Material Fragmentation; Improper or Incorrect Procedure or Method

  THIS EVENT OCCURRED BEFORE REMOVING THE MAKO CHECK POINT PIN ON MAKO THA PROCEDURE. DR. TELLS SALE REP THAT THE CHECKPOINT PIN ON THE MOLAR WAS NOT FOUND AND MAY HAVE ENTERED THE MOLAR. DR. DECIDED THAT IT WOULD BE MORE BENEFICIAL TO THE PATIENT TO LEAVE THE CHECKPOINT PIN IN PLACE RATHER THAN PERFORM A CUP REPLACEMENT TO REMOVE THE CHECKPOINT PIN. AN X-RAY OF THE FRONTAL VIEW WAS THEN TAKEN TO CONFIRM THAT THE INTERNAL DISC HAD NOT BEEN PENETRATED, AND THE REMAINING CHECKPOINT PIN AND MAKO PIN WERE REMOVED TO CLOSE THE WOUND. AFTER PROCEDURE, DR. AND SALES REP HAVE CHECKED THE POSTOPERATIVE CT. THE PIN HAD SUNK TO AROUND 20MM BELOW WHERE IT WAS ORIGINALLY STRUCK. IT WAS DETERMINED THAT IT DID NOT PENETRATE THE INNER BEDROCK.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22199392 ↗
• MalfunctionApr 4, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IN A CASE OF MTHA, WHEN CHECKING THE WOUND TO REMOVE THE PELVIC CHECK-POINT PIN AFTER IMPLANTING, SURGEON NOTICED THE PIN WAS MISSING. AN X-RAY REVEALED A PIN BETWEEN THE CUP AND THE ACETABULUM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21775773 ↗
• MalfunctionMar 31, 2025Fracture; Use of Device Problem; Fracture; Use of Device Problem

  A CHECKPOINT THAT WAS INSERTED OUTSIDE OF THE ACETABULUM BROKE OFF AND REMAINED IN THE PATIENT'S BONE. THIS WAS DETERMINED AT THE TIME OF REMOVAL.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 21732094 ↗
• InjuryFeb 20, 2024Break; Fracture; Break; Fracture

  DURING THE MAKO THA SURGERY, DURING INSERTION OF THE CHECKPOINT ABOVE THE ACETABULUM, THE CHECKPOINT BROKE THROUGH THE INTERNAL DISK AND BURIED ITSELF INTO THE ABDOMINAL CAVITY. ADDITIONAL INFORMATION: WHEN THE CHECKPOINT PIN WAS PLACED WITH A SCREWDRIVER IN A CLOCKWISE DIRECTION ABOVE THE ACETABULUM, IT PERFORATED THE BRITTLE BONE AND PENETRATED THE PELVIS, REACHING INTO THE ABDOMINAL CAVITY.

  Patient problems: Bone Fracture(s); Foreign Body In Patient

  MAUDE report 18744079 ↗
• MalfunctionJan 30, 2020Fracture; Fracture

  SUBMITTED THROUGH A MEDWATCH "DURING A CEMENTLESS RIGHT THA WITH ROBOTIC ARM ASSISTANCE THROUGH DIRECT ANTERIOR APPROACH THE MAKO CHECKPOINT PIN BROKE DURING REMOVAL. WHEN THE PIN WAS REMOVED THE HEAD OF THE CHECKPOINT CAME OUT AND THE NAIL PORTION STAYED IN THE PELVIC BONE. " ORIGINAL CASE TYPE: CEMENTLESS RIGHT THA WITH ROBOTIC ARM ASSISTANCE THROUGH DIRECT ANTERIOR APPROACH, FLUOROSCOPIC ASSISTANCE FOR RIGHT HIP PRIMARY OSTEOARTHRITIS. UPDATE: "SURGERY DATE AND PROCEDURE: (B)(6) 2019, CEMENTLESS RIGHT TOTAL HIP ARTHROPLASTY WITH ROBOTIC ARM ASSISTANCE THROUGH DIRECT ANTERIOR APPROACH, FLUOROSCOPIC ASSISTANCE THERE WAS NO KNOWN DELAY."

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

  MAUDE report 9646678 ↗
• MalfunctionJun 11, 2019Difficult to Remove; Non Reproducible Results; Difficult to Remove; Non Reproducible Results

  CHECKPOINT WAS LEFT IN PATIENT. DOCTOR MADE THIS CHOICE. CASE TYPE: THA. SURGICAL DELAY: X - =15 MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8689847 ↗
• MalfunctionOct 19, 2018Break; Fracture; Break; Fracture

  PELVIC CHECKPOINT BREAK.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7986220 ↗