NA 112340Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00848486017460), received between Apr 24, 2019 and Oct 23, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 23, 2019Break; Break

  DURING IMPACTION OF THE CHECKPOINT, THE CHECKPOINT DRIVER WAS DAMAGED. ONE PIECE OF THE PRONG BROKE AND WAS LOCATED ON THE BACK TABLE. IT IS NOT USABLE AND NEEDS TO BE REPLACED ASAP. CASE TYPE: THA.

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

  MAUDE report 9227615 ↗
• MalfunctionSep 17, 2019Break; Break

  CHECKPOINT DRIVER PIECE BROKE. CASE TYPE: THA. UPDATE: AS PER MPS: "BROKE WHILE IMPACTING THE CHECKPOINT. ONE OF THE LITTLE CLIPS THAT HOLD THE CHECKPOINT BROKE OFF".

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

  MAUDE report 9079084 ↗
• MalfunctionApr 24, 2019Break; Fracture; Break; Fracture

  WHILE IMPACTING THE TIBIAL CHECKPOINT ON THE FEMUR FOR A MAKO THA, A PIECE BROKE OFF FROM THE TIP THAT GRABS THE CHECKPOINT. CASE TYPE: THA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8547683 ↗