NA 3010-19-022Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10705034561431), received between Aug 29, 2023 and Jan 30, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (7 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 18, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 30, 2026Break

  IT WAS REPORTED THAT DURING A PROCEDURE ON AN UNKNOWN DATE, THE TIP OF THE AWL-TIP TAP BROKE OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24222016 ↗
• MalfunctionJan 30, 2026Break

  IT WAS REPORTED THAT DURING A PROCEDURE ON AN UNKNOWN DATE, THE TIP OF THE AWL-TIP TAP BROKE OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24221996 ↗
• MalfunctionJan 30, 2026Break

  IT WAS REPORTED THAT DURING A PROCEDURE ON AN UNKNOWN DATE, THE TIP OF THE AWL-TIP TAP BROKE OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24221995 ↗
• MalfunctionJul 9, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THE AWL BECAME DULL. THERE WAS NO SURGICAL DELAY. THERE WERE NO FRAGMENTS GENERATED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22460939 ↗
• MalfunctionJul 9, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THE AWL BECAME DULL. THERE WAS NO SURGICAL DELAY. THERE WERE NO FRAGMENTS GENERATED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22460921 ↗
• MalfunctionMar 7, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THE TAPS BECAME BLUNT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21553120 ↗
• MalfunctionMar 7, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THE TAPS BECAME BLUNT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21553107 ↗
• MalfunctionMar 7, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THE TAPS BECAME BLUNT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21553086 ↗
• MalfunctionFeb 21, 2024Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT TORQUE IS NOT AS PRECISE ANYMORE. AND THE TAP NOT AS SHARP. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FRAGMENT WAS GENERATED. THERE WERE NO PATIENT OUTCOME OR CONSEQUENCES. THIS REPORT IS FOR ONE (1)5MM NAV DUAL LEAD AWL TIP TAP. THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18748972 ↗
• MalfunctionFeb 21, 2024Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT TORQUE IS NOT AS PRECISE ANYMORE. AND THE TAP NOT AS SHARP. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FRAGMENT WAS GENERATED. THERE WERE NO PATIENT OUTCOME OR CONSEQUENCES. THIS REPORT IS FOR ONE (1)5MM NAV DUAL LEAD AWL TIP TAP. THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18748945 ↗
• MalfunctionAug 29, 2023Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2023, DURING INTRA-OP WHILE USING THE 5.0MM VERSE NABLOCK TAP, SURGEON WAS HAVING DIFFICULTIES ADVANCING THE 5.0MM TAP WHILE UNDER THE NORMAL FORCE OF ADVANCEMENT. APPROXIMATELY 30MM OF THE TAP WAS INTO THE PEDICLE OF L5 (RIGHT) THE DISTAL END OF THE TAP SNAPPED OFF LEAVING THE THREADED PART OF THE TAP IN THE PATIENT'S PEDICLE. THE TAP BROKE AT THE TRANSITION POINT OF THE TREADS AND THE SHAFT OF THE TAP. SURGEON DECIDED THAT NO HARM WOULD COME FROM LEAVING THE BROKEN PART OF THE INSTRUMENT. SUBSEQUENTLY, PEDICLE SCREWS WERE PLACED AT L4 AND S1 AND SKIPPING L5 ON THE RIGHT SIDE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO SURGICAL DELAY. DISTAL TIP OF TAP (APPROX. 30MM) WAS LEFT IN THE PATIENT, UNABLE TO REMOVE WITHOUT ADDITIONAL INTERVENTION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A NAVIGATION ENABLED INSTRUMENTS DUAL LEAD AWL TIP TAP 5MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17642273 ↗