NA 03.211.004Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982076021), received between Apr 28, 2022 and Oct 18, 2023 — classified as 2 malfunctions.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 18, 2023Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A PIECE WAS BROKEN OFF ON THE CONTROL STATIC VARIABLE ANGLE (VA) DRILL GUIDE. IT IS UNKNOWN WHEN THE BREAKAGE OCCURRED. THE DEVICE WAS LAST USED FOR A CASE ON SEPTEMBER 7, 2023. THIS REPORT IS FOR A 2.0MM VARIABLE ANGLE LOCKING DRILL GUIDE/COAXIAL.

  Patient problems: Insufficient Information

  MAUDE report 17958281 ↗
• MalfunctionApr 28, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING AN UNKNOWN SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE 2.7 CONICAL AND COAXIAL DRILL GUIDES DEVICES WOULD NOT SIT ON THE PLATES. ANOTHER LIKE DEVICES WERE USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) VA-LCP DRILL SLEEV 2.7 COAX F/DRILL BIT DEVICE. THIS COMPLAINT INVOLVES TWO (2) DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14243771 ↗