NA 72202009Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010644992), received between Jul 25, 2023 and Jul 25, 2023 — classified as 1 injury.

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

• InjuryJul 25, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, A DRILL TIP PASSING PIN SNAPPED IN HALF WHILE DRILLING A PASSAGE TO PASS AN ACL GRAFT. THE PROCEDURE COULD BE COMPLETED WITH THE SAME DEVICE. THE TWO HALVES WERE REMOVED BY THE SURGEON AND AN X RAY WAS OBTAINED SHOWING FRAGMENTS OF METAL IN THE BONE. A NON-SIGNIFICANT DELAY WAS REPORTED. NO HARM TO DATE.

  Patient problems: Foreign Body In Patient

  MAUDE report 17393559 ↗