NA 03.617.900Recalls & reported problems

Summary

The FDA's MAUDE database contains 77 adverse event reports that list this exact device (DI 10705034717142), received between Apr 11, 2017 and Jan 7, 2026 — classified as 77 malfunctions.

The most frequently reported specific device problem is “Break” (53 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 25 most recent of 77 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 7, 2026Material Integrity Problem

  IT WAS REPORTED THAT ZERO-P VA CAGE LRG LORDOTIC H7 PEEK AND SCRDRIVER T8 SELF-HOLDING ANGL W/SLEEVE WERE INVOLVED IN AN INTRAOPERATIVE EVENT DURING A SPINAL FUSION PROCEDURE. DURING INSERTION OF THE INFERIOR SCREW, TWO ARTICULATING DRIVERS BROKE AND THE TITANIUM PORTION OF THE CAGE DETACHED. THE PIN AT THE ARTICULATING JOINT OF THE DRIVERS SHEARED OFF. THE CAGE WAS REMOVED AND REPLACED WITH A NEW ONE, AND A STRAIGHT SHAFT DRIVER WAS USED TO COMPLETE THE PROCEDURE. THE EVENT RESULTED IN A 10-MINUTE SURGICAL DELAY, BUT THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY ADVERSE PATIENT CONSEQUENCES. ALL DEVICE FRAGMENTS WERE REMOVED WITHOUT ADDITIONAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23990194 ↗
• MalfunctionJan 7, 2026Material Integrity Problem

  IT WAS REPORTED THAT ZERO-P VA CAGE LRG LORDOTIC H7 PEEK AND SCRDRIVER T8 SELF-HOLDING ANGL W/SLEEVE WERE INVOLVED IN AN INTRAOPERATIVE EVENT DURING A SPINAL FUSION PROCEDURE. DURING INSERTION OF THE INFERIOR SCREW, TWO ARTICULATING DRIVERS BROKE AND THE TITANIUM PORTION OF THE CAGE DETACHED. THE PIN AT THE ARTICULATING JOINT OF THE DRIVERS SHEARED OFF. THE CAGE WAS REMOVED AND REPLACED WITH A NEW ONE, AND A STRAIGHT SHAFT DRIVER WAS USED TO COMPLETE THE PROCEDURE. THE EVENT RESULTED IN A 10-MINUTE SURGICAL DELAY, BUT THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY ADVERSE PATIENT CONSEQUENCES. ALL DEVICE FRAGMENTS WERE REMOVED WITHOUT ADDITIONAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23990174 ↗
• MalfunctionSep 2, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE TWO ARTICULATING ZERO PVA DRIVERS WERE STRIPPED DURING THE CASE. ALSO THE BONE TAMP WAS NICKED RESULTING IN A SHARP EDGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22945875 ↗
• MalfunctionSep 2, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE TWO ARTICULATING ZERO PVA DRIVERS WERE STRIPPED DURING THE CASE. ALSO, THE BONE TAMP WAS NICKED RESULTING IN A SHARP EDGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22945845 ↗
• MalfunctionJul 1, 2025Calibration Problem; Compatibility Problem; Calibration Problem; Compatibility Problem

  IT WAS REPORTED THAT THE REPORTER WAS HAVING MAJOR ISSUES WITH THE ANGLED STAR-DRIVE SCREWDRIVER. THE MECHANISM THAT THREADS INTO THE ANGLES DRIVER FROM SCREWDRIVER KEEPS OVER TIGHTENING DURING SCREW INSERTION. IT LOCKS UP AND THE SURGEON CAN NO LONGER CONTINUE TO ADVANCE SCREW FURTHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22373198 ↗
• MalfunctionJul 1, 2025Calibration Problem; Compatibility Problem; Calibration Problem; Compatibility Problem

  IT WAS REPORTED THAT THE REPORTER WAS HAVING MAJOR ISSUES WITH THE ANGLED STARDRIVE SCREWDRIVER. THE MECHANISM THAT THREADS INTO THE ANGLED DRIVER FROM SCREWDRIVER KEEPS OVER TIGHTENING DURING SCREW INSERTION. IT LOCKS UP AND THE SURGEON CAN NO LONGER CONTINUE TO ADVANCE SCREW FURTHER. THIS CONTINUES TO HAPPEN ON A REGULAR BASIS AND IS AN AREA OF MAJOR CONCERN. ISSUES STARTED HAPPENING IN THE LAST 9 MONTHS OR SO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22371119 ↗
• MalfunctionApr 3, 2025Material Integrity Problem; Material Integrity Problem

  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 21762710 ↗
• MalfunctionApr 3, 2025Material Integrity Problem; Material Integrity Problem

  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 HOLE 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 21762552 ↗
• MalfunctionMar 19, 2025Compatibility Problem; Material Integrity Problem; Compatibility Problem; Material Integrity Problem

  IT WAS REPORTED AN ANGLED SCREWDRIVER DOES NOT ASSEMBLE PROPERLY PROVIDING FRICTION AND RESISTANCE WHEN TURNING THE HANDLE. PERPENDICULAR HANDLE DOES NOT FIT ON SLEEVE/WILL NOT SLIDE ALL THE WAY DOWN; THE INNER TUBE IS PROBABLY BENT. AS A RESULT THE INSTRUMENT DOES NOT ANGLE OR ADVANCE THE SCREW PROPERLY. NO SURGICAL DELAY. PROCEDURE COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21642425 ↗
• MalfunctionJan 22, 2024Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THERE WAS AN ISSUE DURING A PROCEDURE ON (B)(6) 2023 WITH THE ANGLED +- STRAIGHT SCREWDRIVERS IN THE ZERO PVA SET IN CASES. IT WAS NOTED THE SCREWDRIVER IS A LITTLE STIFF AND TURNS THE ANGLE OF THE SCREWDRIVER ROUND RATHER THAN THE INNER DRIVER. THERE WAS NO SIGNIFICANT DELAY IN THE CASE. THE SURGERY WAS COMPLETED SUCCESSFULLY AND THE PATIENT IS DOING WELL. THIS REPORT IS FOR ONE ANGLED STARDRIVE SCREWDRIVER T8 WITH SLEEVE/SELF-RETAINING FOR (B)(4) THIS COMPLAINT IS LINKED TO (B)(4). FOR A SECOND EVENT WITH A DIFFERENT PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18553757 ↗
• MalfunctionDec 30, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON UNKNOWN DATE, SCRDRIVER T8 SELF-HOLDING ANGL W/SLEEVE FOUND BROKEN AFTER CASE. NO PATIENT CONSEQUENCE WAS THERE. THIS REPORT IS FOR ONE (1) SCRDRIVER T8 SELF-HOLDING ANGL W/SLEEVE THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16080555 ↗
• MalfunctionDec 2, 2022Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE SCREWDRIVER T8 SELFHOLDING ANGLE W/SLEEVE DID NOT ROTATE WHEN IT WAS PUT TOGETHER. IT WAS TOUGH TURN AND THE SURGEON WAS NOT ABLE TO USE IT. SURGERY WAS DELAYED BY 10 MINUTES DUE TO THE EVENT. THE DRIVER HAD TO BE PULLED APART AND PUT BACK TOGETHER AGAIN. THIS INSTRUMENT WAS NOT USED FOR THE CASE. A STRAIGHT DRIVER WAS USED TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE ANGLED STARDRIVE SCREWDRIVER T8 WITH SLEEVE/SELF-RETAINING. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15907129 ↗
• MalfunctionNov 28, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, DURING INSERTION OF SCREW WITH ZERO-P VA THE ANGLED SCREWDRIVER BROKE AT THE HINGE OF THE DRIVE MECHANISM. THIS CAUSED THE HANDLE TO TURN BUT NOT THE DRIVE MECHANISM. NO SURGICAL DELAY. NO FRAGMENTS WERE GENERATED. PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR AN ANGLED STARDRIVE SCREWDRIVER T8 WITH SLEEVE/SELF-RETAINING. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15873181 ↗
• MalfunctionJun 9, 2022Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, DURING A PROCEDURE THE PUNCH BREAKS DURING BONE PERFORATION, A FRAGMENT REMAINS INSIDE THE PATIENT IN THE VERTEBRAL BODY. THE SCREWDRIVER BROKE WHEN THE DOCTOR WAS INSERTING THE SCREW INTO THE BONE, HE FINISHED PUTTING THE SCREW WITH A STRAIGHT SCREWDRIVER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE (1) ANGLED STARDRIVE SCREWDRIVER T8 WITH SLEEVE/SELF-RETAINING. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14642643 ↗
• MalfunctionMay 4, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, DURING A C4-5 ANTERIOR CERVICAL DISCECTOMY FUSION (ACDF) PROCEDURE USING A ZERO-P VA, IT WAS OBSERVED THAT AFTER THE DISCECTOMY AND DECOMPRESSION WERE PERFORMED, THE SURGEON SELECTED THE SIZE OF THE DESIRED IMPLANT AND PLACED IT INTO POSITION. WHILE ATTEMPTING TO INSERT A 16MM SELF-DRILLING SCREW ON THE RIGHT SIDE OF THE IMPLANT, THE STARDRIVE SCREWDRIVER BROKE. THE DRIVER WAS REMOVED FROM THE FIELD AND REPLACED WITH ANOTHER ONE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAYS. THERE WERE FRAGMENTS GENERATED; HOWEVER, THEY WERE EASILY REMOVED WITHOUT ADDITIONAL INTERVENTION. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) SCRDRIVER T8 SELF-HOLDING ANGL W/SLEEVE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14281116 ↗
• MalfunctionMar 2, 2022Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM THE (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON AN UNKNOWN DATE, THE ANGLED SCREWDRIVER IN A ZEROPVA KIT BROKE. THIS REPORT IS FOR AN UNKNOWN SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4)..

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13652586 ↗
• MalfunctionDec 14, 2021Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SCREWDRIVER WAS FOUND TO BE WORN. THIS REPORT INVOLVES ONE (1) ANGLED STARDRIVE SCREWDRIVER T8 WITH SLEEVE/SELF-RETAINING. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13003517 ↗
• MalfunctionNov 29, 2021Mechanical Problem; Compatibility Problem; Mechanical Problem; Compatibility Problem

  IT WAS REPORTED THAT THE REPORTED ISSUE WAS NOTICED DURING INSPECTION. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12885165 ↗
• MalfunctionApr 12, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE ANGLED STARDRIVE SCREWDRIVER WITH SLEEVE/SELF-RETAINING WAS STRIPPED AND WOULD NOT SELF-RETAIN THE SCREW. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11649884 ↗
• MalfunctionOct 23, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING ANTERIOR CERVICAL FUSION USING THE ZERO VARIABLE ANGLE ZERO-PROFILE SYSTEM WHILE USING THE ANGLED STARDRIVE SCREWDRIVER WITH SLEEVE/SELF RETAINING TO INSERT TITANIUM CERVICAL SPINE SCREW THE DISTAL END OF THE DRIVE BROKE OFF. THE FRAGMENT WAS RETRIEVED AND THE SURGEON FINISHED INSERTING THE SCREW USING THE STRAIGHT SCREWDRIVER IN THE SET. THE DELAY WAS VERY MINIMAL. PROCEDURE OUTCOME WAS UNKNOWN. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: TITANIUM CERVICAL SPINE SCREW (PART# 04.647.836, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR 1 ANGLED STARDRIVE SCREWDRIVER WITH SLEEVE/SELF-RETAINING THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10726256 ↗
• MalfunctionOct 16, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE ANGLED SCREWDRIVER WITH THE SLEEVE WAS BEING USED TO INSERT SCREWS DURING AN UNKNOWN PROCEDURE. AT THE COMPLETION OF THE PROCEDURE, WHEN THE SURGEON REMOVED THE SLEEVE FROM THE ANGLE DRIVER, IT WAS EXTREMELY STIFF AND DIFFICULT TO REMOVE. WHEN PLACING THE SLEEVE BACK ON THE DRIVER, IT WAS ALSO VERY STIFF. NO PATIENT CONSEQUENCE REPORTED. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS: SPINE-US (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) ANGLED STARDRIVE SCREWDRIVER T8 WITH SLEEVE/SELF-RETAINING. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10689507 ↗
• MalfunctionSep 29, 2020Break; Break

  IT WAS REPORTED THAT DURING A C6-7 ACDF PROCEDURE ON (B)(6) 2020, THE ANGLED STARDRIVE SCREWDRIVER WAS BROKEN WHILE ATTEMPTING TO REMOVE THE SCREW FROM ZERO-P. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE USE OF ANOTHER SCREWDRIVER. THERE WERE NO SURGICAL DELAY AND NO PATIENT CONSEQUENCE REPORTED. CONCOMITANT DEVICE REPORTED: UNKNOWN ZERO-P SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) ANGLED STARDRIVE SCREWDRIVER T8 WITH SLEEVE/SELF-RETAINING THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10599553 ↗
• MalfunctionSep 24, 2020Break; Break

  IT WAS REPORTED THAT ON SEPTEMBER 1, 2020, THE ANGLED STARDRIVE SCREWDRIVER IN THE ZERO TVA SET BROKE IN THE SURGEONS HANDS WHILE IN THE PATIENT. THERE WAS A POST-OPERATIVE X-RAY TAKEN AND THE X-RAY CONFIRMED THAT ALL FRAGMENTS WERE REMOVED. THERE WAS A THIRTY (30) TO (40) MINUTE SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT WAS STABLE AFTER THE PROCEDURE. THIS REPORT INVOLVES ONE (1) ANGLED STARDRIVE SCREWDRIVER T8 WITH SLEEVE/SELF-RETAINING. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10579313 ↗
• MalfunctionMay 29, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, WHILE THE SURGEON WAS IMPLANTING THE TITANIUM CERVICAL SPINE SCREW, THE ANGLE STARDRIVE SCREWDRIVER BROKE OFF THE DRIVER SHAFT. THE BROKEN STARDRIVE SCREWDRIVER WAS REMOVED IN ONE PIECE FROM THE SURGICAL SITE. FRAGMENTS WERE GENERATED FROM THE BROKEN DEVICE AND WERE REMOVED EASILY. ANOTHER DRIVER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: TITANIUM CERVICAL SPINE SCREW (PART NUMBER 04.647.836, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE (1) ANGLED STARDRIVE SCREWDRIVER T8 WITH SLEEVE/SELF-RETAINING. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10101391 ↗
• MalfunctionFeb 17, 2020Material Integrity Problem; Material Integrity Problem

  UPDATED EVENT DESCRIPTION CONCOMITANT DEVICE REPORTED: UNKNOWN SCREW (PART #: UNKNOWN, LOT #: UNKNOWN, QUANTITY: 1).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9716585 ↗