NA 03.617.902Recalls & reported problems

Summary

The FDA's MAUDE database contains 103 adverse event reports that list this exact device (DI 10705034717166), received between Dec 15, 2017 and Sep 21, 2026 — classified as 3 injuries, 100 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (57 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 25 most recent of 103 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50839784 ↗
• MalfunctionMay 29, 2026Material Integrity Problem

  IT WAS REPORTED THE TIPS OF THE SCREWDRIVERS ARE WORN DOWN. NO PATIENT HARM. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25330690 ↗
• MalfunctionMay 29, 2026Material Integrity Problem

  IT WAS REPORTED THE TIPS OF THE SCREWDRIVERS ARE WORN DOWN. NO PATIENT HARM. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25330681 ↗
• MalfunctionMay 29, 2026Material Integrity Problem

  IT WAS REPORTED THE TIPS OF THE SCREWDRIVERS ARE WORN DOWN. NO PATIENT HARM. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25330648 ↗
• MalfunctionMay 29, 2026Material Integrity Problem

  IT WAS REPORTED THE TIPS OF THE SCREWDRIVERS ARE WORN DOWN. NO PATIENT HARM. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25330641 ↗
• MalfunctionMay 6, 2026Material Integrity Problem

  IT WAS REPORTED THAT DRIVER STRIPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25096448 ↗
• MalfunctionMay 5, 2026Material Integrity Problem

  IT WAS REPORTED THAT THE SCREWDRIVERS HAD DULL/BROKEN TIPS. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25084360 ↗
• MalfunctionMay 5, 2026Material Integrity Problem

  IT WAS REPORTED THAT THE SCREWDRIVERS HAD DULL/BROKEN TIPS. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25084356 ↗
• MalfunctionMay 5, 2026Material Integrity Problem

  IT WAS REPORTED THAT THE SCREWDRIVERS HAD DULL/BROKEN TIPS. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25084354 ↗
• MalfunctionApr 24, 2026Material Integrity Problem

  IT WAS REPORTED THAT WHILE TORQUING THE FOUR SCREWS ON THE ZERO-P HOUSING, IT WAS NOTICED THAT THE TIPS OF BOTH SCREWDRIVERS WERE SEVERELY WORN; CONSEQUENTLY, THEY LACKED SUFFICIENT GRIP TO PROPERLY APPLY TORQUE. THE SCREWS WERE TIGHTENED AS MUCH AS POSSIBLE WITHOUT CAUSING FURTHER DAMAGE TO THEIR HEADS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24984351 ↗
• MalfunctionApr 24, 2026Material Integrity Problem

  IT WAS REPORTED THAT WHILE TORQUING THE FOUR SCREWS ON THE ZERO-P HOUSING, IT WAS NOTICED THAT THE TIPS OF BOTH SCREWDRIVERS WERE SEVERELY WORN; CONSEQUENTLY, THEY LACKED SUFFICIENT GRIP TO PROPERLY APPLY TORQUE. THE SCREWS WERE TIGHTENED AS MUCH AS POSSIBLE WITHOUT CAUSING FURTHER DAMAGE TO THEIR HEADS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24984332 ↗
• 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 24283913 ↗
• 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 24283911 ↗
• 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 24261199 ↗
• 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 24261191 ↗
• MalfunctionJan 21, 2026Material Integrity Problem

  IT WAS REPORTED TWO (2) SCREWDRIVER SHAFTS WERE NOTED TO BE STRIPPED DURING AN ACDF. SURGEON STRUGGLED TO ADVANCE THE SCREWS WITH THE SCREWDRIVERS ON THE SET. AN ALTERNATIVE KIT WITH THE SAME DRIVE-FEATURE WAS QUICKLY OPENED AND THE CASE WENT AHEAD SUCCESSFULLY. NO PATIENT HARM. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24134087 ↗
• MalfunctionJan 21, 2026Material Integrity Problem

  IT WAS REPORTED TWO (2) SCREW DRIVER SHAFTS WERE NOTED TO BE STRIPPED DURING AN ACDF. SURGEON STRUGGLED TO ADVANCE THE SCREWS WITH THE SCREWDRIVERS ON THE SET. AN ALTERNATIVE KIT WITH THE SAME DRIVE-FEATURE WAS QUICKLY OPENED AND THE CASE WENT AHEAD SUCCESSFULLY. NO PATIENT HARM. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24134078 ↗
• MalfunctionSep 20, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON SEPTEMBER 12, 2024, THE TIP OF DRIVER WORE OUT. NO PATIENT HARM, DELAY, NO FRAGMENT. THIS REPORT IS FOR A STARDRIVE SCREWDRIVER SHAFT T8 SELF-RETAINING/QC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20269331 ↗
• MalfunctionSep 20, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2024 , THE TIP OF DRIVER WORE OUT. NO PATIENT HARM, DELAY, NO FRAGMENT. THIS REPORT IS FOR A STARDRIVE SCREWDRIVER SHAFT T8 SELF-RETAINING/QC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20269322 ↗
• MalfunctionSep 18, 2024Activation, Positioning or Separation Problem; Material Integrity Problem; Activation, Positioning or Separation Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2024 , THE SURGEON WAS DOING A 3 - LEVEL ACDF USING ZERO-P NATURAL PLATE. AFTER IMPLANTING A 7MM ZERO-P NATURAL PLATE AND SPACER AT C6-C7, THEY PLACED 14MM SCREWS. THE TORQUE LIMITING DEVICE WAS NOT PLACED ON THE STRAIGHT SCREW DRIVER RESULTING IN BREAKING OFF THE DRIVER TIP IN THE SCREW HEAD. THE SCREW WAS FULLY PLACED, BUT THE DRIVER TIP WOULD NOT COME OUT. AFTER SOME TIME TRYING TO REMOVE THE BROKEN DRIVER TIP WITH NO SUCCESS, THE SURGEON MOVED ON TO FINISH THE CASE SUCCESSFULLY. THERE WAS AN UNKNOWN SURGICAL DELAY. PATIENT IS DOING GREAT AND IS RECOVERING NICELY. THIS REPORT IS FOR A STARDRIVE SCREWDRIVER SHAFT T8 SELF-RETAINING/QC.

  Patient problems: Foreign Body In Patient

  MAUDE report 20249126 ↗
• MalfunctionJul 29, 2024Compatibility Problem; Material Integrity Problem; Compatibility Problem; Material Integrity Problem

  IT WAS REPORTED DURING THE SURGERY THE HOLDING SLEEVE PARTS OF THE T8 SELF-FASTENING SCREWDRIVER, ARE IN POOR CONDITION DO NOT ALLOW TORQUE TO THE LOCKED SCREWS OF THE PLATE OF THE ZERO-P SYSTEM. THE SURGEON COULD NOT PERFORM THE RESPECTIVE TORQUE TO THE SCREWS, HOWEVER THE SURGERY WAS SUCCESSFULLY COMPLETED, WITHOUT ALTERATIONS IN THE SURGICAL TIMES AND WITHOUT AFFECTING THE PATIENT. THIS REPORT IS FOR HOLDING SLEEVE FOR STARDRIVE SCREWDRIVER SHAFT T8 THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19850123 ↗
• MalfunctionFeb 6, 2024Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2024, THAT BOTH SCREWDRIVER TIPS WERE ROLLED, AND THAT MADE SURGERY DIFFICULT. THE DOCTOR WAS VERY UPSET; IT WAS NOT POSSIBLE TO TORQUE THE LAST SCREW, AND THE OTHERS WERE DIFFICULT BECAUSE OF THE BAD GRIP OF THE TIPS. PLEASE REVIEW AND CHANGE IT SO AS NOT TO HAVE DIFFICULTY WITH IT. THIS REPORT IS FOR ONE (1) SCRDRIVER SHAFT T8 SELF-HOLDING. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18649499 ↗
• MalfunctionFeb 6, 2024Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED ON (B)(6)2024, THAT BOTH SCREWDRIVER TIPS WERE ROLLED, AND THAT MADE SURGERY DIFFICULT. THE DOCTOR WAS VERY UPSET; IT WAS NOT POSSIBLE TO TORQUE THE LAST SCREW, AND THE OTHERS WERE DIFFICULT BECAUSE OF THE BAD GRIP OF THE TIPS. PLEASE REVIEW AND CHANGE IT SO AS NOT TO HAVE DIFFICULTY WITH IT. THIS REPORT IS FOR ONE (1) SCRDRIVER SHAFT T8 SELF-HOLDING THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18649498 ↗
• MalfunctionOct 19, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2023, THE TIPS OF THE INSTRUMENTS IN QUESTION WERE WORN DOWN. THERE WAS NO REPORTED PATIENT OR PROCEDURE INTERACTION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A STARDRIVE SCREWDRIVER SHAFT T8 SELF-RETAINING/QC. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17965743 ↗
• MalfunctionOct 19, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2023, THE TIPS OF THE INSTRUMENTS IN QUESTION WERE WORN DOWN. THERE WAS NO REPORTED PATIENT OR PROCEDURE INTERACTION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A STARDRIVE SCREWDRIVER SHAFT T8 SELF-RETAINING/QC. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17965742 ↗