TRACKER 219455Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886705006571), received between Jan 11, 2019 and May 5, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (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. 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.

• MalfunctionMay 5, 2022Material Deformation; Material Deformation

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE (B)(6) 2022, IT WAS OBSERVED THAT THE TRACKER BONE CLAMP DEVICE WAS NOT WORKING PROPERLY. ACCORDING TO THE REPORT, THE CLAMP DEVICE WOULD NOT STAY CLAMPED BY ITSELF. 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 14290793 ↗
• MalfunctionDec 3, 2020Mechanical Jam; Mechanical Jam

  IT WAS REPORTED BY THE SALES REP THAT DURING A TIBIAL REALIGNMENT PROCEDURE ON (B)(6) 2020, IT WAS OBSERVED THAT THE TRACKER SLOPE SELECT ARM DEVICE WAS NOT LETTING THE DRILL BIT TO GO THROUGH. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10943188 ↗
• MalfunctionJan 11, 2019Mechanical Jam; Mechanical Jam

  IT WAS REPORTED BY THE SALES REP THAT DURING A KNEE REPAIR SURGICAL PROCEDURE, IT WAS OBSERVED THAT HIS CORTICAL SCREW, 4.5MMX 42MM BECAME STRIPPED WHEN THE SURGEON WAS INSERTING IT INTO VERY HARD BONE. THE SALES REP REPORTED THAT THE SURGEON HAD TAPPED WHEN PREPPING THE BONE HOLE. THE SALES REP REPORTED THAT HIS TRACKER SLOPE SELECT ARM AND HIS TRACKER DRILL BIT ALSO BECAME COLD WELDED DURING THE PROCEDURE. THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER LIKE DEVICE IN THE SAME BONE HOLE WITH NO PATIENT CONSEQUENCES. THERE WAS A 25 MINUTE DELAY IN THE PROCEDURE. THE SALES REP COULD NOT PROVIDE THE LOT NUMBERS FOR THE DEVICES. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8241492 ↗