NA 03.647.993Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034720869), received between Oct 11, 2018 and Apr 3, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K112068); they may or may not involve this specific model.

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.

• MalfunctionApr 3, 2025Failure to Cut; Material Twisted/Bent; Failure to Cut; Material Twisted/Bent

  IT WAS REPORTED THAT THIS WAS A HARD CASE. USER'S HOUSE SET WAS 10+ YEARS OLD SO THEY HAD MULTIPLE ISSUE. THE AWL WAS BENT AND DULL SO IT WOULD NOT MAKE A WHOLE FOR THE SCREW. THE PATIENTS BONE WAS STRONG AND IT MADE THE WEAK AWL BEND. THEY THEN TRIED PUTTING THE SCREW IN AND THE ANGLED DRIVER AND STRAIGHT DRIVER STRIPPED. THE MALLET ALSO WAS NO LONGER FULLY CEMENTED ON THE SHAFT SO THEY COULDN'T BANG IN THE SCREW ONCE THE MALLET BROKE. FRAGMENTS WERE NOT GENERATED. SURGERY WAS DELAYED DUE TO THE REPORTED EVENT. PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21762756 ↗
• MalfunctionApr 7, 2021Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT IN (B)(6) 2021 PRIOR TO THE SURGERY IT WAS FOUND THAT THE ANGLE AWL LOAN SET WAS BLUNT. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THIS REPORT IS FOR ONE (1) 2.5MM ANGLED AWL. THIS IS REPORT 1 OF 1 FOR COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11631005 ↗
• 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). THIS REPORT IS FOR ONE (1) ANGLED AWL. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7957930 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K112068. One submission often covers many models, so check the product and lot details in each record.

• Z-0455-2014 · Sep 30, 2013 · Terminated
  Synthes Zero-P VA Implant 7 MM Height Parallel Sterile The Synthes Zero-P VA Implant 7 MM Height Parallel Sterile is a stand alone anterior cervical interbody fusion device indica