NA SD03.617.902Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034701950), received between Jun 13, 2024 and Jun 21, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 21, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE INSTRUMENTS HAVE AN UNKNOWN ALLEGATION. IT OBSERVED DURING INSPECTION OF INSTRUMENTS. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) UNIVERSAL JOINT ANGLED DRIVE THIS IS REPORT 3 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19588587 ↗
• MalfunctionJun 13, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE INSTRUMENTS WERE STRIPPED, BROKEN AND DID NOT WORK. THE DRIVERS WERE STRIPPED, AN AREA OF THE ANGLED DRIVER WHERE THE JOINT WAS, FLARED OUT AND DID NOT ALLOW THE PIECE TO WORK WITH OTHER INSTRUMENTS. THE TIPS OF THE DRIVER AND DRILL HAD ALSO BROKEN OFF. IT OBSERVED DURING INSPECTION OF INSTRUMENTS. THERE WAS NO PATIENT INVOLVEMENT. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT INVOLVES ONE (1) UNIVERSAL JOINT ANGLED DRIVE THIS IS REPORT 2 OF 10 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19533039 ↗