ORTHOMATCH 71442171Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00885556497104), received between Jul 6, 2020 and Nov 3, 2025 — classified as 3 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (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. 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 3, 2025Break; Break

  IT WAS REPORTED THAT, DURING A KNEE REPLACEMENT PROCEDURE, THE ORTHOMATCH TIB-INSERT IMPLANT IMPACTOR BROKE WHILE IMPACTING THE FINAL TIBIAL BASE. THE FEMORAL IMPACTOR WAS USED TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23460449 ↗
• MalfunctionMay 27, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) ORTHOMATCH TIB-INSERT IMPLANT IMPACTOR BROKE IN HALF WHEN THE SURGEON WAS IMPACTING THE TIBIAL IMPLANT. NO EXCESSIVE FORCE WAS USED AND IT WAS DONE WITHIN THE TECHNIQUE. 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 22089574 ↗
• MalfunctionNov 28, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE ORTHOMATCH TIB-INSERT IMPLANT IMPACTOR BROKE. IT IS UNKNOWN IF ANY PIECE FELL INSIDE THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20805653 ↗
• MalfunctionOct 1, 2024Break; Break

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE ORTHOMATCH TIB-INSERT IMPLANT IMPACTOR BROKE. THE PROCEDURE WAS PERFORMED, AFTER A NON-SIGNIFICANT DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20344489 ↗
• MalfunctionMay 14, 2022Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A ORTHOMATCH TIB-INSERT IMPLANT IMPACTOR WAS FOUND BROKEN. SURGERY WAS FINISHED WITHOUT ANY DELAY, WITH THE SAME DEVICE. NO BROKEN PIECES FELL INSIDE THE PATIENT. NO HARM TO THE PATIENT OR FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14403107 ↗
• InjuryDec 30, 2021Break; Break

  IT WAS REPORTED THAT, DURING TKA SURGERY, AN ORTHOMATCH TIB-INSERT IMPLANT IMPACTOR BROKE OFF INSIDE THE PATIENT. BROKEN PIECES WERE REMOVED FROM THE PATIENT WITH TWEEZERS. THE PROCEDURE WAS COMPLETED USING A S+N BACK-UP DEVICE. SURGERY WAS LESS THAN OR EQUAL TO 30MINS DELAYED. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13118891 ↗
• InjurySep 1, 2020Break; Break

  IT WAS REPORTED THAT DURING SURGERY THE ORTHOMATCH TIB-INSERT IMPLANT IMPACTOR BROKE WHILE INSIDE THE PATIENT, IT BROKE INSIDE BUT NONE OF THE PIECES FELL INSIDE THE WOUND. ALL PIECES WERE RECOVERED. NO PATIENT INJURY OR DELAY. PROCEDURE WAS COMPLETED WITH THE SAME INSTRUMENT. NO COMPLICATIONS OR CHANGES IN TECHNIQUE DURING THE OPERATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10479543 ↗
• InjuryJul 6, 2020Break; Break

  IT WAS REPORTED THAT DURING AN ANTHEM TKA PROCEDURE, THE ORTHOMATCH TIBIAL-INSERT IMPLANT IMPACTOR BROKE DURING ACTUAL IMPLANT IMPACTION. THE DEVICE WAS INSIDE THE PATIENT. IT IS UNKNOWN HOW THE PROCEDURE CONTINUED. THERE WERE NO DELAYS AND NO INJURIES REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10232514 ↗