NA 03.231.008Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982077356), received between Sep 24, 2021 and Nov 2, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (3 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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 2, 2023Break; Break

  IT WAS REPORTED THAT THE TIP OF VA DRILL GUIDE 4.3 LONG BROKE. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) VA DRILL GUIDE 4.3 LONG. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18054963 ↗
• MalfunctionDec 7, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2022, WHEN ATTEMPTING TO USE THE 4.3MM DRILL GUIDE, THE DRILL BIT WOULD NOT PASS. SEVERAL DRILL BITS WERE TRIED, AND IT WAS DETERMINED THAT THE GUIDE WAS FAULTY. THE SURGEON WAS ABLE TO PASS THE DRILL BIT UNDER POWER AND USED THE DRILL GUIDE TO COMPLETE THE CASE. THERE WAS NO SURGICAL DELAY AND THERE WAS NO PATIENT CONSEQUENCE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 4.3MM VA SPHERICAL DRILL GUIDE LONG F/5.0MM VA LCKNG SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15930924 ↗
• MalfunctionDec 1, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SWITZERLAND AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE 4.3MM DRILL BIT DID NOT FIT IN THE DRILL SLEEVE 03.231.008 DURING PREOPERATIVE WORKSHOP. THERE WERE NO PATIENT CONSEQUENCES. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 4.3MM VA SPHERICAL DRILL GUIDE LONG F/5.0MM VA LCKNG SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15894332 ↗
• MalfunctionSep 24, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT, WHEN THE CURVED CONDYLAR PLATE AND THE AIMING ARM WAS ATTACHED, IT WAS NOT ABLE TO ATTACH DUE TO THE STRIPPAGE OF THE SCREW HOLE OF THE PLATE. WHILE USING THE AIMING ARM ON THE NEW UNKNOWN PLATE, THE NEUTRAL SLEEVES WERE NOT CONNECTING TO THE HARPOON. THE PEDIATRIC AIMING ARM WAS OUTRIGGER. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH (10) MINUTES DELAY. NO PATIENT CONSEQUENCE. THIS REPORT IS FOR (1) 4.3MM VA SPHERICAL DRILL GUIDE LONG F/5.0MM VA LCKNG SCREWS. THIS IS REPORT 6 OF 8 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12525811 ↗