NA 1299-01-058Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295026952), received between Nov 23, 2022 and Nov 23, 2022 — classified as 1 malfunction.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 23, 2022Break; Entrapment of Device; No Apparent Adverse Event; Break; Entrapment of Device; No Apparent Adverse Event

  I WAS ALERTED BY CSSD STAFF OF AN INCIDENT IN (B)(6) 2022, WHERE AN ATTUNE NAVIGATION PIN BROKE AND WAS NOT PICKED UP UNTIL THE POST OPERATIVE X-RAY WAS DONE. THE SURGEON IDENTIFIED THIS AND TALKED TO THE PATIENT. SURGEON STATES HE TOLD THE PATIENT HE DOES NOT NEED TO REMOVE IT AS IT IS IN BONE, AND UNLESS IT STARTS CAUSING AN ISSUE. WHICH HE ALSO STATED THAT IT HAS NOT SINCE. THE HOSPITAL HAS STARTED THEIR INVESTIGATION NOW HENCE WHY THEY HAVE ONLY ALERTED THE COMPANY RECENTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15852069 ↗