NA 03.110.023Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886982071941), received between Sep 27, 2021 and Mar 3, 2026 — classified as 8 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 3, 2026Break

  IT WAS REPORTED THAT ON (B)(6) 2026 THE DEVICE SNAPPED OFF ON ONE END. THERE WAS GENERATION OF FRAGMENTS WHICH WERE REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THERE WAS NO PATIENT CONSEQUENCES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24500578 ↗
• 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) 1.8 VARIABLE ANG LCKNG DRILL GUIDE/CONE THIS IS REPORT 5 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13577181 ↗
• 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) 1.8 VARIABLE ANG LCKNG DRILL GUIDE/CONE THIS IS REPORT 2 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13577158 ↗
• 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) 1.8MM VARIABLE ANGLE LOCKING DRILL GUIDE/CONE THIS IS REPORT 4 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13576937 ↗
• 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 (1) 1.8MM VARIABLE ANGLE LOCKING DRILL GUIDE/CONE. THIS IS REPORT 2 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13576929 ↗
• MalfunctionFeb 10, 2022Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT, BOTH THE DRILL GUIDES HAVE CHIPS IN THEM. THE DEPTH GAUGE WAS BENT AND DID NOT HOOK. NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) 1.8 VARIABLE ANG LCKNG DRILL GUIDE/CONE. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13506557 ↗
• MalfunctionFeb 10, 2022Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT, BOTH THE DRILL GUIDES HAVE CHIPS IN THEM. THE DEPTH GAUGE WAS BENT AND DID NOT HOOK. NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) 1.8 VARIABLE ANG LCKNG DRILL GUIDE/CONE. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13506556 ↗
• MalfunctionSep 27, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT, WHILE INSPECTING THE INSTRUMENTS AFTER GOING THROUGH THE DECONTAMINATION PROCESS THERE WERE 2 INSTRUMENTS THAT WERE DAMAGED. THIS ITEM WAS A SMALL SCREWDRIVER AND THE WOODEN HANDLE IS CRACKED. AS THE WOOD SWELLS WITH WATER AND HEAT THE CRACK IS MORE PROFOUND. THE SECOND ITEM WAS A CONE AND THE TIP OF THE CONE WAS BEND. HOWEVER, WHEN THE ITEM WAS SET ASIDE A STAFF MEMBER AT THE HOSPITAL DISPOSED OF IT IN THE RED SHARPS CONTAINER AND WAS UNABLE TO RETRIEVED DUE TO SAFETY CONCERNS. THIS REPORT IS FOR (1) 1.8MM VARIABLE ANGLE LOCKING DRILL GUIDE/CONE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12533441 ↗