NA 03.617.905Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 10705034717197), received between Jan 19, 2018 and Feb 6, 2026 — classified as 29 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (25 reports).

1 other recall cover devices cleared under the same FDA submission (K112068, K152239); 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 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 6, 2026Mechanical Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE DRIVERS HAD STRIPPED ON THE SET AND WOULD NOT TIGHTEN THE SCREW. TO COMPLETE THE PROCEDURE A T8 DRIVER WAS OPENED FROM ANOTHER TRAUMA SET. THERE WAS NO IMPACT TO PATIENT OR PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24283912 ↗
• MalfunctionFeb 4, 2026Mechanical Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE DRIVERS HAD STRIPPED ON THE SET AND WOULD NOT TIGHTEN THE SCREW. THE T8 DRIVER FROM ANOTHER SET WAS OPENED TO COMPLETE THE PROCEDURE. THERE WAS NO IMPACT TO THE PATIENT OR PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24261190 ↗
• MalfunctionJun 21, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE INSTRUMENTS HAVE AN UNKNOWN ALLEGATION. IT OBSERVED DURING INSPECTION OF INSTRUMENTS. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) INNER SHAFT FOR ANGLED SCREWDRIVER. THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19590183 ↗
• MalfunctionJun 21, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE INSTRUMENTS HAVE AN UNKNOWN ALLEGATION. IT OBSERVED DURING INSPECTION OF INSTRUMENTS. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) INNER SHAFT FOR ANGLED SCREWDRIVER THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19588591 ↗
• MalfunctionJun 13, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE INSTRUMENTS WERE STRIPPED, BROKEN AND DID NOT WORK. THE DRIVERS WERE STRIPPED, AN AREA OF THE ANGLED DRIVER WHERE THE JOINT WAS, FLARED OUT AND DID NOT ALLOW THE PIECE TO WORK WITH OTHER INSTRUMENTS. THE TIPS OF THE DRIVER AND DRILL HAD ALSO BROKEN OFF. IT OBSERVED DURING INSPECTION OF INSTRUMENTS. THERE WAS NO PATIENT INVOLVEMENT. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT INVOLVES ONE (1) INNER SHAFT FOR ANGLED SCREWDRIVER THIS IS REPORT 7 OF 10 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19533215 ↗
• MalfunctionJun 13, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE INSTRUMENTS WERE STRIPPED, BROKEN AND DID NOT WORK. THE DRIVERS WERE STRIPPED, AN AREA OF THE ANGLED DRIVER WHERE THE JOINT WAS, FLARED OUT AND DID NOT ALLOW THE PIECE TO WORK WITH OTHER INSTRUMENTS. THE TIPS OF THE DRIVER AND DRILL HAD ALSO BROKEN OFF. IT OBSERVED DURING INSPECTION OF INSTRUMENTS. THERE WAS NO PATIENT INVOLVEMENT. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT INVOLVES ONE (1) INNER SHAFT FOR ANGLED SCREWDRIVER THIS IS REPORT 10 OF 10 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19533193 ↗
• MalfunctionJun 13, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE INSTRUMENTS WERE STRIPPED, BROKEN AND DID NOT WORK. THE DRIVERS WERE STRIPPED, AN AREA OF THE ANGLED DRIVER WHERE THE JOINT WAS, FLARED OUT AND DID NOT ALLOW THE PIECE TO WORK WITH OTHER INSTRUMENTS. THE TIPS OF THE DRIVER AND DRILL HAD ALSO BROKEN OFF. IT OBSERVED DURING INSPECTION OF INSTRUMENTS. THERE WAS NO PATIENT INVOLVEMENT. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT INVOLVES ONE (1) INNER SHAFT FOR ANGLED SCREWDRIVER THIS IS REPORT 9 OF 10 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19533176 ↗
• MalfunctionJun 13, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE INSTRUMENTS WERE STRIPPED, BROKEN AND DID NOT WORK. THE DRIVERS WERE STRIPPED, AN AREA OF THE ANGLED DRIVER WHERE THE JOINT WAS, FLARED OUT AND DID NOT ALLOW THE PIECE TO WORK WITH OTHER INSTRUMENTS. THE TIPS OF THE DRIVER AND DRILL HAD ALSO BROKEN OFF. IT OBSERVED DURING INSPECTION OF INSTRUMENTS. THERE WAS NO PATIENT INVOLVEMENT. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT INVOLVES ONE (1) INNER SHAFT FOR ANGLED SCREWDRIVER THIS IS REPORT 8 OF 10 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19533162 ↗
• MalfunctionJun 13, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE INSTRUMENTS WERE STRIPPED, BROKEN AND DID NOT WORK. THE DRIVERS WERE STRIPPED, AN AREA OF THE ANGLED DRIVER WHERE THE JOINT WAS, FLARED OUT AND DID NOT ALLOW THE PIECE TO WORK WITH OTHER INSTRUMENTS. THE TIPS OF THE DRIVER AND DRILL HAD ALSO BROKEN OFF. IT OBSERVED DURING INSPECTION OF INSTRUMENTS. THERE WAS NO PATIENT INVOLVEMENT. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT INVOLVES ONE (1) INNER SHAFT FOR ANGLED SCREWDRIVER. THIS IS REPORT 6 OF 10 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19533108 ↗
• MalfunctionJun 13, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE INSTRUMENTS WERE STRIPPED, BROKEN AND DID NOT WORK. THE DRIVERS WERE STRIPPED, AN AREA OF THE ANGLED DRIVER WHERE THE JOINT WAS, FLARED OUT AND DID NOT ALLOW THE PIECE TO WORK WITH OTHER INSTRUMENTS. THE TIPS OF THE DRIVER AND DRILL HAD ALSO BROKEN OFF. IT OBSERVED DURING INSPECTION OF INSTRUMENTS. THERE WAS NO PATIENT INVOLVEMENT. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT INVOLVES ONE (1) INNER SHAFT FOR ANGLED SCREWDRIVER THIS IS REPORT 5 OF 10 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19533092 ↗
• MalfunctionJun 13, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE INSTRUMENTS WERE STRIPPED, BROKEN AND DID NOT WORK. THE DRIVERS WERE STRIPPED, AN AREA OF THE ANGLED DRIVER WHERE THE JOINT WAS, FLARED OUT AND DID NOT ALLOW THE PIECE TO WORK WITH OTHER INSTRUMENTS. THE TIPS OF THE DRIVER AND DRILL HAD ALSO BROKEN OFF. IT OBSERVED DURING INSPECTION OF INSTRUMENTS. THERE WAS NO PATIENT INVOLVEMENT. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT INVOLVES ONE (1) INNER SHAFT FOR ANGLED SCREWDRIVER THIS IS REPORT 4 OF 10 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19533075 ↗
• MalfunctionJun 13, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE INSTRUMENTS WERE STRIPPED, BROKEN AND DID NOT WORK. THE DRIVERS WERE STRIPPED, AN AREA OF THE ANGLED DRIVER WHERE THE JOINT WAS, FLARED OUT AND DID NOT ALLOW THE PIECE TO WORK WITH OTHER INSTRUMENTS. THE TIPS OF THE DRIVER AND DRILL HAD ALSO BROKEN OFF. IT OBSERVED DURING INSPECTION OF INSTRUMENTS. THERE WAS NO PATIENT INVOLVEMENT. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT INVOLVES ONE (1) INNER SHAFT FOR ANGLED SCREWDRIVER. THIS IS REPORT 1 OF 10 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19533007 ↗
• MalfunctionJan 2, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON UNKNOWN EVENT DATE DEVICE WORN DOWN. NO PATIENT CONSEQUENCES. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. THIS REPORT IS FOR ONE (1) INNER SHAFT FOR ANGLED SCREWDRIVER THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18426885 ↗
• MalfunctionJan 2, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON UNKNOWN EVENT DATE DEVICE WORN DOWN. NO PATIENT CONSEQUENCES. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. THIS REPORT IS FOR ONE (1) INNER SHAFT FOR ANGLED SCREWDRIVER THIS IS REPORT 2 OF 2 FOR COMPLAINT PC-(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18426883 ↗
• MalfunctionJan 5, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, THE SCREWDRIVER BROKE AT THE UNIVERSAL JOINT AS IT WAS FINAL TIGHTENING AT AN ANGLE, CAUSING THE UNIVERSAL JOINT TO EXPAND AND STOP MOVEMENT. TO REMEDY THE SITUATION, THE SURGEON USED ANOTHER SCREWDRIVER, BUT THE SAME THING HAPPENED. THE THIRD SCREWDRIVER WAS PERFECT. THERE WAS NO PATIENT HARM AND NO SURGICAL DELAY. NO FRAGMENTS WERE GENERATED AND THERE WAS NO MEDICAL ISSUE AT ALL. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE INNER SHAFT FOR ANGLED SCREWDRIVER. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16102741 ↗
• MalfunctionJan 5, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, THE SCREWDRIVER BROKE AT THE UNIVERSAL JOINT AS IT WAS FINAL TIGHTENING AT AN ANGLE, CAUSING THE UNIVERSAL JOINT TO EXPAND AND STOP MOVEMENT. TO REMEDY THE SITUATION, THE SURGEON USED ANOTHER SCREWDRIVER, BUT THE SAME THING HAPPENED. THE THIRD SCREWDRIVER WAS PERFECT. THERE WAS NO PATIENT HARM AND NO SURGICAL DELAY. NO FRAGMENTS WERE GENERATED AND THERE WAS NO MEDICAL ISSUE AT ALL. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE INNER SHAFT FOR ANGLED SCREWDRIVER. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16102738 ↗
• MalfunctionJan 3, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, DURING ACDF OF C4-C7, THE U JOINT BROKE ON THE ZERO-P ANGLE SCREWDRIVERS BECAUSE OF THE ANGLE AND THE TORQUE ON THEM. THERE WAS NO TIME LOST IN THE PROCEDURE, AND THERE WAS NO HARM TO THE PATIENT. THE SCREWDRIVER WAS REPLACED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE INNER SHAFT FOR ANGLED SCREWDRIVER. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16085785 ↗
• MalfunctionJan 3, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, DURING ACDF OF C4-C7, THE U JOINT BROKE ON THE ZERO-P ANGLE SCREWDRIVERS BECAUSE OF THE ANGLE AND THE TORQUE ON THEM. THERE WAS NO TIME LOST IN THE PROCEDURE, AND THERE WAS NO HARM TO THE PATIENT. THE SCREWDRIVER WAS REPLACED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE INNER SHAFT FOR ANGLED SCREWDRIVER. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16085783 ↗
• MalfunctionDec 27, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING FINAL TIGHTENING THE SURGEON HAD TWO ANGLED DRIVERS BREAK OFF AT THE TIP. THERE WAS NO DELAY IN SURGERY, AND NO PATIENT HARM WAS REPORTED. THIS REPORT INVOLVES ONE INNER SHAFT FOR ANGLED SCREWDRIVER. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16052567 ↗
• MalfunctionDec 27, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING FINAL TIGHTENING THE SURGEON HAD TWO ANGLED DRIVERS BREAK OFF AT THE TIP. THERE WAS NO DELAY IN SURGERY, AND NO PATIENT HARM WAS REPORTED. THIS REPORT INVOLVES ONE INNER SHAFT FOR ANGLED SCREWDRIVER. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16052563 ↗
• MalfunctionJun 9, 2022Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE STAR DRIVE TIP OF THE ANGLED SCREWDRIVER HAS COMPLETELY COME AWAY FROM THE SHAFT AND IS NO LONGER FIT FOR PURPOSE. A DIFFERENT SCREWDRIVER WAS USED OFF THE SET. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT IMPACT. THIS REPORT INVOLVES ONE (1) INNER SHAFT FOR ANGLED SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14643433 ↗
• MalfunctionApr 27, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE SURGEON WAS PERFORMING AN ACDF USING ZERO-P VARIABLE ANGLE (VA). HE WENT TO TIGHTEN A CERVICAL SPINE SCREW WITH THE ANGLED SCREWDRIVER (SHAFT FOR ANGLED SCREWDRIVER AND HEX ADAPTOR). THE INSTRUMENT DIDN¿T SEEM TO WORK CORRECTLY. THE SURGERY WAS COMPLETED WITHOUT ANY DELAY OR ISSUES. UPON INSPECTING THE PART AFTER SURGERY, AT LEAST ONE COMPONENT (HEX ADAPTOR) WAS FOUND BENT. THERE WAS NO FRAGMENT GENERATED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WAS NO SURGICAL DELAY REPORTED. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: 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 COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) INNER SHAFT FOR ANGLED SCREWDRIVER. THIS REPORT IS 1 OF 1 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11734423 ↗
• MalfunctionFeb 18, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SURGEON INDICATED THAT HE BELIEVED THE YOKE ON THE INNER SHAFT FOR ANGLED SCREWDRIVER HAD WORN OUT. THE SALES CONSULTANT HAS THREE (3) OF THESE DRIVERS AND ALL THREE (3) SEEMED TO BE WORN AT THE SAME LEVEL. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) INNER SHAFT FOR ANGLED SCREWDRIVER. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11343549 ↗
• MalfunctionFeb 18, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SURGEON INDICATED THAT HE BELIEVED THE YOKE ON THE INNER SHAFT FOR ANGLED SCREWDRIVER HAD WORN OUT. THE SALES CONSULTANT HAS THREE (3) OF THESE DRIVERS AND ALL THREE (3) SEEMED TO BE WORN AT THE SAME LEVEL. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) INNER SHAFT FOR ANGLED SCREWDRIVER. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11343511 ↗
• MalfunctionFeb 18, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SURGEON INDICATED THAT HE BELIEVED THE YOKE ON THE INNER SHAFT FOR ANGLED SCREWDRIVER HAD WORN OUT. THE SALES CONSULTANT HAS THREE (3) OF THESE DRIVERS AND ALL THREE (3) SEEMED TO BE WORN AT THE SAME LEVEL. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) INNER SHAFT FOR ANGLED SCREWDRIVER. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11343466 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K112068, K152239. 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