TRACKER 219453Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886705006557), received between May 9, 2022 and Sep 15, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2023Break; Break

  THIS IS REPORT 2 OF 2 FOR (B)(4).. IT WAS REPORTED BY SALES REP THAT DURING AN ANTERIOR TIBIAL SURGERY PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE TRACKER CUT BLOCK W/PIVOT TOTAL DEVICE PIVOT PORTION SNAPPED OF FROM ONE SIDE. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED WITH LESS THAN 30 MINUTES SURGICAL DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17755986 ↗
• MalfunctionMay 9, 2022Material Deformation; Material Deformation

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE TRACKER CUTTING BLOCK TOTAL AND THE TRACKER CUT BLOCK W/PIVOT TOTAL WERE BENT AND NOT MATCHING ANYMORE. ANOTHER LIKE DEVICES WERE USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS COMPLAINT INVOLVES TWO (2) DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14337493 ↗