NA 014485Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010025869), received between Jul 15, 2019 and Jul 15, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionJul 15, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION SURGERY, WHEN POSITIONING, THE DRILL GOT BROKEN INSIDE THE PATIENT'S ANATOMY. BACK-UP DEVICE WAS USED TO COMPLETE THE SURGERY. NO PATIENT INJURIES OR SIGNIFICANT DELAY REPORTED. SOME BROKEN PIECES WERE REMOVED WITH PLIERS, HOWEVER, AS PER REPORTER RESPONSE NOT ALL THE PIECES WERE REMOVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8788751 ↗