ORTHOMATCH 71442162Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885556583753), received between Sep 16, 2021 and Oct 23, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 23, 2024Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) ORTHOMATCH TIB CUT BLK 3 DEG {} CONNECTO BROKE DURING INITIAL USE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20514875 ↗
• MalfunctionNov 28, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA, A ORTHOMATCH TIB CUT BLK 3 DEG {} CONNECTO BROKE, THEREFORE, THE SURGEON HAD TO FIX THE GUIDE IN HIS FREE HAND, CAUSING DELAYS DUE TO CHECKING THE ALIGNMENT OF THE CUT. SURGERY WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH THE SAME DEVICE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18223204 ↗
• MalfunctionJul 22, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING PTJ SURGERY, THE ORTHOMATCH TIB CUT BLK 3 DEG CONNECTO LOOSENED THE PIN THAT FITS INTO THE TIBIAL CUTTING BUR, NOT AFFECTING THE SURGERY, AS THE TIBIAL CUTTING HAD ALREADY BEEN DONE. THIS OCCURED WHILE THE DEVICE WAS HANDLED INSIDE THE PATIENT. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE SAME DEVICE. SURGERY WAS NOT DELAYED AS A CONSEQUENCE OF THIS ISSUE. THE PATIENT WAS NOT HARMED BEYOND THE REPORTED INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15088059 ↗
• MalfunctionSep 16, 2021Break; Break

  IT WAS REPORTED THAT THE ORTHOMATCH TIB CUT BLK 3 HAD AN UNSPECIFIED FAILURE. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE WITH A DELAY OF FEWER THAN 30 MINUTES. NO FURTHER COMPLICATION WERE REPORTED. THE INVESTIGATION FOUND THAT THE TABS OF THE DEVICE PAIRED WITH THE MATING SLIDING MECHANISM ARE BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12485440 ↗