NA 111653Recalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 00848486017316), received between Dec 18, 2018 and Sep 16, 2026 — classified as 2 injuries, 47 malfunctions.

The most frequently reported specific device problem is “Fracture” (29 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 25 most recent of 49 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Fracture

  The following was reported "While removing the checkpoint from the patient's pelvis, the checkpoint broke, leaving the tip inside the patient's body."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50791874 ↗
• MalfunctionSep 11, 2026Fracture

  The following information was provided: While removing the checkpoint from the patient's pelvis, the checkpoint fractured, leaving its tip inside the patient's body. The procedure was performed using a Mako robot (ROB 2408).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50728655 ↗
• MalfunctionFeb 5, 2026Fracture; Material Fragmentation

  THE FOLLOWING INFORMATION WAS PROVIDED: MAKO CHECKPOINT IMPACTION SCREW HEX 3.5MM FRACTURE. THE FRAGMENT COULD NOT BE REMOVED AND REMAINS IN THE PATIENT'S BODY PER THE SURGEON'S JUDGMENT.

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

  MAUDE report 24267816 ↗
• MalfunctionJan 28, 2026Fracture

  THE FOLLOWING INFORMATION WAS PROVIDED: AT THE END OF THE OPERATION, WHEN WE WANTED TO REMOVE THE PRODUCT FROM THE PATIENT, WE NOTICED THAT IT HAD BROKEN INSIDE THE PATIENT AND COULD NOT BE REMOVED. THE SURGEON IN THE OPERATING ROOM SHOWED ME THE BROKEN PRODUCT AND DIRECTED THE X-RAY IMAGE OF THE BROKEN PRODUCT REMAINING INSIDE THE PATIENT. NOTE: WE HAD EXPERIENCED THE SAME SITUATION TWICE BEFORE. IN THIS CASE, IT DOES NOT SEEM APPROPRIATE FOR US TO USE THIS PRODUCT IN THE FIELD.

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

  MAUDE report 24203751 ↗
• MalfunctionSep 16, 2025Fracture; Fracture

  THE FOLLOWING WAS REPORTED: ""BREAKAGE OF 3.5MM HEX IMPACTION CHECKPOINT, FRAGMENT LEFT IN PATIENT. AFTER THE 3.5MM CHECKPOINT WAS REMOVED FROM THAT PATIENTS' ANATOMY, IT WAS NOTICED BY THE SCRUB TEAM AND MYSELF THAT THE VERY TIP HAD BROKEN OFF IN THE PATIENTS BONE AND WAS NOT RETRIEVABLE. "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23061513 ↗
• MalfunctionAug 28, 2025Fracture; Fracture

  THE CUSTOMER REPORTED THAT DURING A THA PROCEDURE, THE CHECKPOINT THREAD SPLIT AND BROKE WHEN TRYING TO UNSCREW/ REMOVE THE CHECKPOINT FROM THE ACETABULUM. THE STRYKER REP FURTHER REPORTED THAT A BROKEN PIECE OF THE CHECKPOINT WAS LEFT INSIDE THE PATIENT. NO ADDITIONAL SCANS OF THE PATIENT WERE MADE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22919827 ↗
• MalfunctionAug 28, 2025Fracture; Material Fragmentation; Fracture; Material Fragmentation

  WHEN REMOVING THE CHECKPOINT 3.5MM HEX, IMPACTION (ACETABULAR CHECKPOINT) FROM THE PATIENT'S PELVIS AT THE CONCLUSION OF THE CASE, TIP OF CHECKPOINT WAS FOUND TO BE BROKEN OFF INSIDE BONE. ATTENDING SURGEON ATTEMPTED TO REMOVE BROKEN PIECE BUT WAS UNABLE TO. ATTENDING SURGEON MADE CLINICAL DECISION TO LEAVE DEVICE FRAGMENT IN PATIENT.

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

  MAUDE report 22919269 ↗
• MalfunctionJul 11, 2025Fracture; Fracture

  AFTER THE CHECKPOINT WAS NO LONGER NEEDED, IT WAS REMOVED FROM THE PATIENT, BUT IT BROKE AND REMAINED IN THE PATIENT'S BONE.

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

  MAUDE report 22477320 ↗
• MalfunctionApr 29, 2025Fracture; Material Fragmentation; Fracture; Material Fragmentation

  THE SALES REP REPORTED: "CHECKPOINT (111653) 3.5 HEX TIP BROKE WHILST REMOVING IT FROM THE ACETABULAR BONE."

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

  MAUDE report 21924459 ↗
• MalfunctionMar 20, 2025Fracture; Material Fragmentation; Fracture; Material Fragmentation

  SALES REP REPORT: "DURING A MAKO THA PROCEDURE, AN ESTIMATED 1CM OF THE 3.5 HEX IMPACTION CHECKPOINT BROKE OFF AND WAS LEFT IN THE PATIENTS ACETABULUM. THIS OCCURRED AFTER CUP REAMING/ IMPACTION WHEN THE SURGEON WAS USING THE CORRECT CHECKPOINT DRIVER TO REMOVE THE CHECKPOINT."

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

  MAUDE report 21652733 ↗
• MalfunctionMar 3, 2025Fracture; Material Fragmentation; Fracture; Material Fragmentation

  THE FOLLOWING WAS REPORTED BY THE CUSTOMER: "DURING REMOVAL OF ACETABULAR/PELVIC CHECK POINT, THE CHECKPOINT BROKE OF AND TIP OF IT REMAINS INSIDE THE PATIENT."

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

  MAUDE report 21503573 ↗
• MalfunctionFeb 24, 2025Fracture; Material Fragmentation; Fracture; Material Fragmentation

  NO NEW INFORMATION.

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

  MAUDE report 21449729 ↗
• MalfunctionFeb 5, 2025Fracture; Material Fragmentation; Fracture; Material Fragmentation

  NO NEW INFORMATION.

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

  MAUDE report 21315304 ↗
• MalfunctionAug 5, 2024Break; Material Fragmentation; Break; Material Fragmentation

  DURING REMOVAL AFTER IMPLANT INSERTION, THE TIP BROKE OFF AND FELL ONTO THE PELVIC SURFACE. THE CIRCUMFERENCE WAS ENLARGED WITH A K-WIRE, ETC., AND THE DAMAGED FRAGMENT WAS PICKED UP AND REMOVED.

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

  MAUDE report 19913404 ↗
• InjuryApr 18, 2022Use of Device Problem; Appropriate Device Problem Term/Code Not Available; Use of Device Problem; Appropriate Device Problem Term/Code Not Available

  AS REPORTED: "CHECKPOINT WAS LEFT IN GREATER TROCH AND REMOVED POST OP. SURGICAL DELAY > 30 MINUTES. CASE TYPE / APPLICATION: THA" SPOKE TO MPS. AFTER SURGERY WAS COMPLETE AND THE PATIENT WAS OUT OF THE O.R., POST-OP X-RAY SHOWED THE CHECKPOINT LEFT IN THE PATIENT. PATIENT WAS BROUGHT BACK INTO THE O.R., PUT BACK UNDER ANESTHESIA, AND THE CHECKPOINT WAS REMOVED. THERE WAS NO INTRA-OPERATIVE DELAY, MPS WAS TRYING TO REPORT THAT THE REMOVAL TOOK > 30 MINUTES. MPS MAY BE ABLE TO PROVIDE SOME ADDITIONAL PATIENT INFORMATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 14135862 ↗
• InjuryApr 6, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  DURING MAKO THA PROCEDURE THE PATIENTS WOUND WAS CLOSED WITH THE 3.5MM CHECKPOINT STILL IN THE TROCHANTER. THE POST OP X-RAY MADE THE SURGEON AND STAFF AWARE. THE PATIENT WAS BROUGHT BACK INTO OR TO HAVE THE CHECKPOINT REMOVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 11618456 ↗
• MalfunctionMay 8, 2020Fracture; Fracture

  WHEN THE CHECKPOINT, 3.5 HEX IMPACTION WAS REMOVED, THE PIN WAS BROKEN. THE BROKEN PART OF THE PIN WAS REMOVED SAFELY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10038184 ↗
• MalfunctionMar 23, 2020Fracture; Fracture

  AFTER RETRIEVING CHECKPOINT SCREW AT THE PELVIS SIDE, IT WAS FOUND THAT TIP OF IT WAS CHIPPED. X-RAY COULDN'T FIND BROKEN PIECE. AFTER THAT, BROKEN PIECE WAS FOUND IN THE BONE EXCISED BY REAMING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9866070 ↗
• MalfunctionMar 18, 2020Fracture; Fracture

  PATIENT UNDERWENT THA. CHECKPOINT SCREW WAS REMOVED AND FOUND TO BE BROKEN. SURGEON THOUGHT REMAINING WAS NOT A BIG ISSUE, SO FINISHED OPERATION WITHOUT RETRIEVING BROKEN PIECE. BROKEN PIECE REMAINED IN PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 9850303 ↗
• MalfunctionFeb 26, 2020Fracture; Fracture

  THE CUSTOMER REPORTED THAT DURING A ROBOTIC LEFT HIP THE SURGEON WAS SCREWING IN THE CHECKPOINT FOR THE ROBOT. THE STEM OF THE CHECKPOINT SNAPPED AND THE TIP HAS BEEN LEFT INSIDE THE PATIENT'S LEFT PELVIS / ACETABULA. THE SURGEON LEFT THE PIECE IN SITU AS REMOVING IT WOLD HAVE CAUSED MORE DAMAGE TO THE PATIENT. THE PIECE IS FLUSH TO THE BONE AND THERE IS NO METAL VISIBLE.

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

  MAUDE report 9758245 ↗
• MalfunctionFeb 14, 2020Break; Fracture; Break; Fracture

  WHEN DR. (B)(6) PULLED THE IMPACTION CHECKPOINT OUT OF THE PELVIS, A SMALL TIP OF IT BROKE OFF AND WAS LEFT IN THE PATIENT. DR. (B)(6) DECIDED TO LEAVE IT AND DECLARED NO CONCERN FOR THE PATIENT. CASE TYPE: THA.

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

  MAUDE report 9711078 ↗
• MalfunctionFeb 4, 2020Fracture; Fracture

  THE PELVIC CHECKPOINT BROKE OFF IN THE PATIENT WHEN DR. JERABEK TRIED TO TAKE IT OUT. DR. JERABEK ELECTED TO LEAVE THE BROKEN CHECKPOINT TIP IN THE PATIENT. SURGICAL DELAY = 15 MINUTES. CASE TYPE: THA. RIGHT SIDE.

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

  MAUDE report 9663274 ↗
• MalfunctionJan 30, 2020Fracture; Fracture

  SUBMITTED THROUGH A MEDWATCH "DURING THE PROCEDURE A PORTION OF THE ACETABULAR CHECKPOINT REMAINED WITHIN THE PELVIS. IT WAS BURIED IN THE BONE. IT WAS NOT NEAR THE JOINT NOR ANY OTHER METAL. IT WAS NOT PROMINENT FROM THE BONE AND NOT IRRITATING ANY SOFT TISSUES. FURTHER DEBRIDEMENT WOULD HAVE DAMAGED THE BONE IN ORDER TO REMOVE." ORIGINAL CASE TYPE: RIGHT THA WITH DIRECT ANTERIOR APPROACH WITH ROBOTIC ARM ASSISTANCE. UPDATE: "CEMENTLESS RIGHT TOTAL HIP ARTHROPLASTY WITH DIRECT ANTERIOR APPROACH WITH ROBOTIC ARM ASSISTANCE. THE ISSUE WAS NOTICED WHEN ATTEMPT TO REMOVE THE CHECKPOINT PIN; NO KNOWN SURGICAL DELAY."

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

  MAUDE report 9646681 ↗
• MalfunctionJan 17, 2020Break; Fracture; Break; Fracture

  PIN PART OF CHECKPOINT BROKE OFF INSIDE PATIENT PELVIS. CASE TYPE: THA.

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

  MAUDE report 9602204 ↗
• MalfunctionJan 17, 2020Break; Fracture; Break; Fracture

  ACETABULUM CHECKPOINT BROKE OFF UPON REMOVAL. PIECE WAS REMOVED FROM HIP USING MIDAS BURR. CASE TYPE: THA. SURGICAL DELAY: = 15 MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9602191 ↗