NA 03.211.003Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982076014), received between Feb 22, 2022 and Apr 2, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 2, 2024Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT DRILL GUIDE HANDLE WOULD NOT KEY AND BENT ON OCCASIONS. NO OPERATION WAS INVOLVED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 2.0 VA LCKNG DRILL GUIDE/VARIABLE THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19023447 ↗
• MalfunctionApr 28, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THIS IS REPORT 1 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 CONI F/DRILL BIT DEVICE. THIS COMPLAINT INVOLVES TWO (2) DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14243430 ↗
• MalfunctionFeb 22, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SURGEON HAD DIFFICULTY INSERTING THE VA DRILL GUIDES INTO THE VA HOLES. THE GUIDE WAS NOT SEATING PROPERLY. NO OTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 2.0 VA LCKNG DRILL GUIDE/VARIABLE. THIS IS REPORT 1 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13577175 ↗
• MalfunctionFeb 22, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SURGEON HAD DIFFICULTY INSERTING THE VA DRILL GUIDES INTO THE VA HOLES. THE GUIDE WAS NOT SEATING PROPERLY. NO OTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 2.0 VA LCKNG DRILL GUIDE/VARIABLE. THIS IS REPORT 3 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13577154 ↗
• MalfunctionFeb 22, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE SURGEON HAD DIFFICULTY INSERTING THE VA DRILL GUIDES INTO THE VA HOLES. THE GUIDE WAS NOT SEATING PROPERLY. NO OTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 2.0MM VARIABLE ANGLE LOCKING DRILL GUIDE/VARIABLE. THIS IS REPORT 3 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13576934 ↗
• MalfunctionFeb 22, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE SURGEON HAD DIFFICULTY INSERTING THE VA DRILL GUIDES INTO THE VA HOLES. THE GUIDE WAS NOT SEATING PROPERLY. NO OTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 2.0MM VARIABLE ANGLE LOCKING DRILL GUIDE/VARIABLE THIS IS REPORT 1 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13576925 ↗