NA 03.617.941Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034717272), received between Oct 11, 2018 and Oct 13, 2021 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 13, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING AN ANTERIOR CERVICAL DISCECTOMY AND FUSION, THE ANGLED DRIVER WAS BROKEN WHILE INSERTING THE 2ND SCREW. THE ADAPTER WAS CLEANLY BROKEN WHERE IT CONNECTS TO THE HANDLE AND PART OF THE ADAPTER REMAINED IN THE HANDLE. NO FRAGMENTS WERE GENERATED. THE SURGEON USED A STRAIGHT SCREW DRIVER TO FINISH THE PROCEDURE. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) HEX ADAPTOR-QC HIGH-STRENGTH. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12627911 ↗
• MalfunctionMar 22, 2021Compatibility Problem; Compatibility Problem

  IT WAS REPORTED THAT ON (B)(6), 2021 DURING AN ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) WHILE TIGHTENING A CERVICAL SPINE SCREW WITH THE ANGLED SCREWDRIVER (SHAFT FOR ANGLED SCREWDRIVER AND HEX ADAPTOR), THE INSTRUMENT DIDN¿T WORK CORRECTLY. THE SURGERY WAS COMPLETED WITHOUT ANY DELAY OR ISSUES WITH A STRAIGHT SCREWDRIVER FROM OUR SET. UPON INSPECTING THE PART AFTER SURGERY IT WAS DISCOVERED THAT AT LEAST ONE COMPONENT (HEX ADAPTOR) WAS BENT. CERVICAL SPINE SCREW (PART# 04.647.836; LOT# UNKNOWN; QUANTITY 1). INNER SHAFT FOR ANGLED SCREWDRIVER (PART# 03.617.905; LOT# UNKNOWN; QUANTITY: 1). THIS REPORT IS FOR ONE (1) HEX ADAPTOR-QC HIGH-STRENGTH. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11545965 ↗
• MalfunctionOct 11, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, DURING ZERO-PROFILE VARIABLE ANGLE(VA) PROCEDURE, THE HANDLE OF ANGLED AWL CAME OFF BEHIND THE CASE AFTER THE SURGEON USED THE MALLET ON THE BACK. DURING THE PROCEDURE, QUICK CONNECT OF HEX ADAPTOR BROKE AS IT WAS ENTERED IN THE SCREW. THE QUICK CONNECT SHAFT THAT GOES INTO THE RATCHETING SCREWDRIVER HANDLE BROKE WERE IT CONNECT SO THAT IT CANNOT ENTER IN THE HANDLE. THE BROKEN PIECE IS STILL INSIDE THE HANDLE AND CANNOT BE REMOVED. THERE WAS NO SURGICAL DELAY REPORTED. PROCEDURE WAS SUCCESSFULLY COMPLETED. IT CAME OUT OF PATIENT FINE YET FELL OFF WHEN PASSING IT OFF. PATIENT WAS NOT HARMED DUE TO MALFUNCTION. CONCOMITANT DEVICE REPORTED: SCREW (PART UNKNOWN, LOT UNKNOWN, QUANTITY 1), MALLET (PART UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) HEX ADAPTOR. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7958001 ↗